ORCID Profile
0000-0002-2785-5864
Current Organisations
Royal North Shore Hospital
,
Imperial College London
,
UNSW Sydney
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Publisher: Springer Science and Business Media LLC
Date: 14-08-2013
DOI: 10.1007/S00134-013-3044-3
Abstract: Bleeding frequently complicates critical illness and may have serious consequences. Our objectives are to describe the predictors of major bleeding and the association between bleeding and mortality in medical-surgical critically ill patients receiving heparin thromboprophylaxis. We prospectively studied patients from 67 intensive care units and six countries enrolled in a thromboprophylaxis trial (NCT00182143) comparing dalteparin with unfractionated heparin. Patients with trauma, orthopedic surgery or neurosurgery were excluded. Trained research coordinators used a validated tool to document bleeding, which underwent duplicate independent blinded adjudication. Major bleeding was defined as hypovolemic shock, bleeding into critical sites, requiring an invasive intervention or transfusion of at least two units of red blood cells, or associated with hypotension or tachycardia in the absence of other causes. Adjusted Cox proportional hazard regression analysis was used to identify major bleeding predictors and the association between bleeding and mortality. Among 3,746 patients, bleeding occurred in 208 [5.6 %, 95 % confidence interval (CI) 4.9-6.3 %]. Time-dependent predictors were prolonged activated partial thromboplastin time [hazard ratio (HR) 1.10, 1.05-1.14 per 10 s increase], lower platelet count (HR 1.16, 1.09-1.24 per 50 × 10(9)/L decrease), therapeutic heparin (HR 3.26, 1.72-6.17), antiplatelet agents (HR 1.38, 1.02-1.88), renal replacement therapy (HR 1.75, 1.20-2.56), and recent surgery (HR 1.64, 1.01-2.65). Type of pharmacologic thromboprophylaxis was not associated with bleeding. Patients with bleeding had a higher risk of in-hospital death (HR 2.09, 1.69-2.57). As major bleeding has modifiable risk factors and is associated with in-hospital mortality, strategies to mitigate these factors should be evaluated in critically ill patients.
Publisher: Springer Science and Business Media LLC
Date: 04-09-2019
DOI: 10.1007/S12028-019-00835-Z
Abstract: Neurocritical care is devoted to the care of critically ill patients with acute neurological or neurosurgical emergencies. There is limited information regarding epidemiological data, disease characteristics, variability of clinical care, and in-hospital mortality of neurocritically ill patients worldwide. We addressed these issues in the Point PRevalence In Neurocritical CarE (PRINCE) study, a prospective, cross-sectional, observational study. We recruited patients from various intensive care units (ICUs) admitted on a pre-specified date, and the investigators recorded specific clinical care activities they performed on the subjects during their first 7 days of admission or discharge (whichever came first) from their ICUs and at hospital discharge. In this manuscript, we analyzed the final data set of the study that included patient admission characteristics, disease type and severity, ICU resources, ICU and hospital length of stay, and in-hospital mortality. We present descriptive statistics to summarize data from the case report form. We tested differences between geographically grouped data using parametric and nonparametric testing as appropriate. We used a multivariable logistic regression model to evaluate factors associated with in-hospital mortality. We analyzed data from 1545 patients admitted to 147 participating sites from 31 countries of which most were from North America (69%, N = 1063). Globally, there was variability in patient characteristics, admission diagnosis, ICU treatment team and resource allocation, and in-hospital mortality. Seventy-three percent of the participating centers were academic, and the most common admitting diagnosis was subarachnoid hemorrhage (13%). The majority of patients were male (59%), a half of whom had at least two comorbidities, and median Glasgow Coma Scale (GCS) of 13. Factors associated with in-hospital mortality included age (OR 1.03 95% CI, 1.02 to 1.04) lower GCS (OR 1.20 95% CI, 1.14 to 1.16 for every point reduction in GCS) pupillary reactivity (OR 1.8 95% CI, 1.09 to 3.23 for bilateral unreactive pupils) admission source (emergency room versus direct admission [OR 2.2 95% CI, 1.3 to 3.75] admission from a general ward versus direct admission [OR 5.85 95% CI, 2.75 to 12.45 and admission from another ICU versus direct admission [OR 3.34 95% CI, 1.27 to 8.8]) and the absence of a dedicated neurocritical care unit (NCCU) (OR 1.7 95% CI, 1.04 to 2.47). PRINCE is the first study to evaluate care patterns of neurocritical patients worldwide. The data suggest that there is a wide variability in clinical care resources and patient characteristics. Neurological severity of illness and the absence of a dedicated NCCU are independent predictors of in-patient mortality.
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC11917
Publisher: BMJ
Date: 07-12-1996
Publisher: American Thoracic Society
Date: 15-08-2017
Publisher: Wiley
Date: 2012
Publisher: Springer Science and Business Media LLC
Date: 31-01-2012
DOI: 10.1007/S00134-012-2478-3
Abstract: PURPOSE: To determine whether fever is associated with an increased or decreased risk of death in patients admitted to an intensive care unit (ICU) with infection. METHODS: We evaluated the independent association between peak temperature in the first 24 h after ICU admission and in-hospital mortality according to whether there was an admission diagnosis of infection using a database of admissions to 129 ICUs in Australia and New Zealand (ANZ) (n = 269,078). Subsequently, we sought to confirm or refute the ANZ database findings using a validation cohort of admissions to 201 ICUs in the UK (n = 366,973). RESULTS: A total of 29,083/269,078 (10.8%) ANZ patients and 103,191/366,973 (28.1%) of UK patients were categorised as having an infection. In the ANZ cohort, adjusted in-hospital mortality risk progressively decreased with increasing peak temperature in patients with infection. Relative to the risk at 36.5-36.9°C, the lowest risk was at 39-39.4°C (adjusted OR 0.56 95% CI 0.48-0.66). In patients without infection, the adjusted mortality risk progressively increased above 39.0°C (adjusted OR 2.07 at 40.0°C or above 95% CI 1.68-2.55). In the UK cohort, findings were similar with adjusted odds ratios at corresponding temperatures of 0.77 (95% CI 0.71-0.85) and 1.94 (95% CI 1.60-2.34) for infection and non-infection groups, respectively. CONCLUSIONS: Elevated peak temperature in the first 24 h in ICU is associated with decreased in-hospital mortality in critically ill patients with an infection randomised trials are needed to determine whether controlling fever increases mortality in such patients.
Publisher: Springer Science and Business Media LLC
Date: 10-08-2022
DOI: 10.1007/S12028-022-01551-X
Abstract: Management of patients with severe traumatic brain injury (sTBI) is highly variable and inconsistently aligned with evidence derived from high-quality trials, including those examining intravenous fluid resuscitation and use of decompressive craniectomy surgery. This study explored the barriers and facilitators of general and specific evidence-based practices in sTBI from the perspectives of stakeholder clinicians. This was a qualitative study of semistructured interviews conducted with specialist clinicians responsible for acute care of patients with sTBI. Interview analysis was guided by the Theoretical domains framework (TDF), and key themes were mapped to relevant TDF behavioral domains. Ten neurosurgeons, 12 intensive care specialists, and three trauma physicians from six high-income countries participated between May 2020 and May 2021. Key TDF domains were environmental context and resources, social influences, and beliefs about consequences. Evidence-aligned management of patients with sTBI is perceived to be facilitated by admission to academic research-oriented hospitals, development of local practice protocols, and interdisciplinary collaboration. Determinants of specific practices varied and included health policy change for fluid resuscitation and development of patient-centered goals for surgical decision-making. In choosing interventions for patients with sTBI, clinicians integrate local environmental, social, professional, and emotional influences with evidence and associated clinical practice guideline recommendations. This study highlights determinants of evidence-based practice that may inform implementation efforts and thereby improve outcomes for patients with sTBI.
Publisher: Springer Science and Business Media LLC
Date: 04-12-2017
Publisher: Wiley
Date: 26-11-2017
Abstract: The Sepsis-3 task force recommends the use of the quick Sequential Organ Failure Assessment (qSOFA) score to identify risk for adverse outcomes in patients presenting with suspected infection. Lactate has been shown to predict adverse outcomes in patients with suspected infection. The aim of the study is to investigate the utility of a post hoc lactate threshold (≥2 mmol/L) added qSOFA score (LqSOFA Retrospective cohort study was conducted on a merged dataset of suspected or proven sepsis patients presenting to ED across multiple sites in Australia and The Netherlands. Patients are identified as candidates for quality improvement initiatives or research studies at respective sites based on local screening procedures. Data-sharing was performed across sites of demographics, qSOFA, SOFA, lactate thresholds and outcome data for included patients. LqSOFA In a merged dataset of 12 555 patients where a full qSOFA score and outcome data were available, LqSOFA The lactate ≥2 mmol/L threshold-based LqSOFA
Publisher: Sciedu Press
Date: 03-07-2022
DOI: 10.5430/JHA.V11N1P23
Abstract: There is paucity of data on critical care resources, disaster preparedness, and sepsis management in countries within the Asia Pacific region. An online survey was conducted from 15 April to 17 July 2020. Snowball s ling through the Asia Pacific Sepsis Alliance and network contacts was used to recruit respondents. Countries were grouped according to the World Bank Country Income 2019 classification into lower-middle income (LMIC), upper-middle income (UMIC), and high-income (HIC). Survey questions addressed to hospital characteristics, critical care resources, disaster preparedness, and sepsis management. In total, 59 hospitals from 15 countries responded (33 LMICs, 8 UMICs, 18 HICs) with most responses from the Philippines (10 16.9%). Median [Inter-quartile range (IQR)] hospital and Intensive Care Unit (ICU) bed capacity was 798 (500–1,001) and 37 (19–59), respectively. Median (IQR) doctor-to-patient and nurse-to-patient day ratios were 1:5 (1:3–1:8) and 1:2 (1:1–1:2), respectively. Availability of 24/7 physiotherapy services, 24/7 Medical resonance Imaging (MRI), point-of-care lactate, and “reserve” antibiotics was limited. Most ICUs had a disaster management plan (88%) and access to Personal Protective Equipment (96%). The most commonly adopted sepsis guideline was the Surviving Sepsis C aign guidelines (77%). LMIC/UMIC ICUs had lower nurse-to patient ratio and surge capacity along with limited access to 24/7 physiotherapy and MRI services, and interventions like Extra Corporeal Membrane Oxygenation, and Continuous Renal Replacement Therapy. Self-reported adoption and adherence to sepsis guidelines was higher in LMICs/UMICs than HICs. In the Asia Pacific region, critical care resources, disaster preparedness and management of sepsis vary considerably between countries across different income categories. In particular, low surge and isolation capacity in LMICs highlights the need for better health service planning and preparation.
Publisher: Massachusetts Medical Society
Date: 03-05-2018
DOI: 10.1056/NEJMC1803563
Publisher: Wiley
Date: 18-02-2014
DOI: 10.1111/AAS.12241
Publisher: Massachusetts Medical Society
Date: 21-02-2013
DOI: 10.1056/NEJMC1215977
Publisher: Informa UK Limited
Date: 06-08-2013
DOI: 10.4161/VIRU.25855
Publisher: Springer Science and Business Media LLC
Date: 07-2023
Publisher: Frontiers Media SA
Date: 18-04-2022
Abstract: To develop a risk prediction model for the occurrence of severe acute kidney injury (AKI) in intensive care unit (ICU) patients receiving fluid resuscitation. We conducted a secondary analysis of the Crystalloid vs. Hydroxyethyl Starch Trial (CHEST) trial, a blinded randomized controlled trial that enrolled ICU patients who received intravenous fluid resuscitation. The primary outcome was the first event in a composite outcome of doubling of serum creatinine and/or treatment with renal replacement treatment (RRT) within 28 days of randomization. The final model developed using multivariable logistic regression with backwards elimination was validated internally and then translated into a predictive equation. Six thousand seven hundred twenty-seven ICU participants were studied, among whom 745 developed the study outcome. The final model having six variables, including admission diagnosis of sepsis, illness severity score, mechanical ventilation, tachycardia, baseline estimated glomerular filtration rate and emergency admission. The model had good discrimination (c-statistic = 0.72, 95% confidence interval 0.697–0.736) and calibration (Hosmer-Lemeshow test, χ 2 = 14.4, p = 0.07) for the composite outcome, with a c-statistic after internal bootstrapping validation of 0.72, which revealed a low degree of over-fitting. The positive predictive value and negative predictive value were 58.8 and 89.1%, respectively. The decision curve analysis indicates a net benefit in prediction of severe AKI using the model across a range of threshold probabilities between 5 and 35%. Our model, using readily available clinical variables to identify ICU patients at high risk of severe AKI achieved good predictive performance in a clinically relevant population.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-2017
DOI: 10.1097/PCC.0000000000001340
Abstract: Sepsis, worldwide the leading cause of death in children, has now been recognized as the global health emergency it is. On May 26, 2017, the World Health Assembly, the decision-making body of the World Health Organization, adopted a resolution proposed by the Global Sepsis Alliance to improve the prevention, diagnosis, and management of sepsis. To discuss the implications of this resolution for children worldwide. The resolution highlights sepsis as a global threat and urges the 194 United Nations member states to take specific actions and implement appropriate measures to reduce its human and health economic burden. The resolution is a major step toward achieving the targets outlined by the Sustainable Developmental Goals for decreasing mortality in infants and children, but implementing it will require a concerted global effort.
Publisher: Oxford University Press (OUP)
Date: 23-11-2018
DOI: 10.1093/NDT/GFX308
Abstract: There is no consensus whether higher intensity dose renal replacement therapy (RRT) compared with standard intensity RRT has survival benefit and achieves better renal recovery in acute kidney injury (AKI). In an in idual patient data meta-analysis, we merged in idual patient data from randomized controlled trials (RCTs) comparing high with standard intensity RRT in intensive care unit patients with severe AKI. The primary outcome was all-cause mortality. The secondary outcome was renal recovery assessed as the proportion of patients who were RRT dependent at key trial endpoints and by time to the end of RRT dependence. Of the eight prospective RCTs assessing different RRT intensities, seven contributed in idual patient data (n = 3682) to the analysis. Mortality was similar between the two groups at 28 days [769/1884 (40.8%) and 744/1798 (41.4%), respectively P = 0.40] after randomization. However, more participants assigned to higher intensity therapy remained RRT dependent at the most common key study point of 28 days [e.g. 292/983 (29.7%) versus 235/943 (24.9%) relative risk 1.15 (95% confidence interval 1.00-1.33) P = 0.05]. Time to cessation of RRT through 28 days was longer in patients receiving higher intensity RRT (log-rank test P = 0.02) and when continuous renal replacement therapy was used as the initial modality of RRT (log-rank test P = 0.03). In severe AKI patients, higher intensity RRT does not affect mortality but appears to delay renal recovery. Australian New Zealand Clinical Trials Registry (ANZCTR) identifier ACTRN12615000394549 (www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615000394549).
Publisher: Cambridge University Press (CUP)
Date: 08-2020
DOI: 10.1017/THG.2020.60
Abstract: Previous genetic association studies have failed to identify loci robustly associated with sepsis, and there have been no published genetic association studies or polygenic risk score analyses of patients with septic shock, despite evidence suggesting genetic factors may be involved. We systematically collected genotype and clinical outcome data in the context of a randomized controlled trial from patients with septic shock to enrich the presence of disease-associated genetic variants. We performed genomewide association studies of susceptibility and mortality in septic shock using 493 patients with septic shock and 2442 population controls, and polygenic risk score analysis to assess genetic overlap between septic shock risk/mortality with clinically relevant traits. One variant, rs9489328, located in AL589740 . 1 noncoding RNA, was significantly associated with septic shock ( p = 1.05 × 10 –10 ) however, it is likely a false-positive. We were unable to replicate variants previously reported to be associated ( p 1.00 × 10 –6 in previous scans) with susceptibility to and mortality from sepsis. Polygenic risk scores for hematocrit and granulocyte count were negatively associated with 28-day mortality ( p = 3.04 × 10 –3 p = 2.29 × 10 –3 ), and scores for C-reactive protein levels were positively associated with susceptibility to septic shock ( p = 1.44 × 10 –3 ). Results suggest that common variants of large effect do not influence septic shock susceptibility, mortality and resolution however, genetic predispositions to clinically relevant traits are significantly associated with increased susceptibility and mortality in septic in iduals.
Publisher: Springer Science and Business Media LLC
Date: 26-10-2011
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2012
Publisher: Elsevier
Date: 2014
Publisher: Cold Spring Harbor Laboratory
Date: 28-08-2021
DOI: 10.1101/2021.08.24.21262515
Abstract: The choice of intravenous fluid for fluid therapy in critically ill adult patients remains a matter of debate. Currently, crystalloids are used more often than colloids, with ongoing controversy over the relative efficacy and safety of buffered salt solutions (BSS) versus normal saline (0.9% sodium chloride). In 2021 two large pragmatic trials enrolling critically ill patients will add substantial new data to address this controversy. We will conduct a systematic review and meta-analysis of randomised controlled trials (RCTs) that will include the data from these two trials to provide clinicians with the most up to date evidence and robust evidence to guide their choice of crystalloid fluids. We will include RCTs that compare the effect of buffered salt solutions to normal saline for fluid resuscitation and/or fluid therapy in critically ill adults, on all-cause mortality and other patient centred outcomes. We will perform a search that includes the electronic databases MEDLINE and EMBASE, and clinical trial registries. Two reviewers will independently screen titles and abstracts, perform full article reviews and extract study data, with discrepancies resolved by a third reviewer. We will report study characteristics and assess risk of bias using the Cochrane Risk-of-Bias tool. We will perform Hartung-Knapp-Sidik-Jonkman random-effects aggregate data meta-analysis whenever it is feasible to do so. We will evaluate overall certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. This systematic review and meta-analysis does not require ethical approval as it does not involve primary data collection. We will publish our results in a peer-reviewed scientific journal and present them at national and international scientific conferences. CRD42021243399 This systematic review will provide up-to-date evidence to answer the focused clinical question: In adult patients who are critically ill, does administering balanced crystalloid solutions for fluid therapy reduce mortality and other patient-centered outcomes, compared with administering 0.9% sodium chloride? We will conduct a systematic review according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines, searching three electronic databases, clinical trial registries and published conference abstracts, with two independent reviewers evaluating studies and extracting data. A meta-analysis will assess the primary outcome of all-cause mortality at 90 days and secondary outcomes of ventilator and vasopressor free days, renal replacement therapy use, incidence of acute kidney injury, and patient quality of life outcomes. The limitations of this review include the clinical heterogeneity of the included trials, ersity of the targeted population receiving fluid therapy, variability in the composition of balanced crystalloid solutions, and timing of initiation of study crystalloids. We will address all limitations with the Grading of Recommendations, Assessment, Development and Evaluations framework.
Publisher: Massachusetts Medical Society
Date: 09-06-2022
DOI: 10.1056/NEJMC2204390
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2016
Publisher: Wiley
Date: 08-1987
Publisher: Massachusetts Medical Society
Date: 04-04-2019
Publisher: Massachusetts Medical Society
Date: 30-01-2014
Publisher: S. Karger AG
Date: 2008
DOI: 10.1159/000148400
Abstract: i Background/Aims: /i The optimal dose of renal replacement therapy (RRT) in acute renal failure (ARF) is uncertain. i Methods: /i The Randomized Evaluation of Normal versus Augmented Level Replacement Therapy Trial tests the hypothesis that higher dose continuous veno-venous hemodiafiltration (CVVHDF) at an effluent rate of 40 ml/kg/h will increase survival compared to CVVHDF at 25 ml/kg/h of effluent dose. i Results: /i This trial is currently randomizing critically ill patients in 35 intensive care units in Australia and New Zealand with a planned s le size of 1,500 patients. This trial will be the largest trial ever conducted on acute blood purification in critically ill patients. i Conclusion: /i A trial of this magnitude and with demanding technical requirements poses design difficulties and challenges in the logistics, conduct, data collection, data analysis and monitoring. Our report will assist in the development of future trials of blood purification in intensive care. This study was registered with ClinicalTrials.gov (NCT00221013).
Publisher: Springer Science and Business Media LLC
Date: 25-08-2022
DOI: 10.1186/S13054-022-04120-Y
Abstract: Timing of initiation of kidney-replacement therapy (KRT) in critically ill patients remains controversial. The Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial compared two strategies of KRT initiation (accelerated versus standard) in critically ill patients with acute kidney injury and found neutral results for 90-day all-cause mortality. Probabilistic exploration of the trial endpoints may enable greater understanding of the trial findings. We aimed to perform a reanalysis using a Bayesian framework. We performed a secondary analysis of all 2927 patients randomized in multi-national STARRT-AKI trial, performed at 168 centers in 15 countries. The primary endpoint, 90-day all-cause mortality, was evaluated using hierarchical Bayesian logistic regression. A spectrum of priors includes optimistic, neutral, and pessimistic priors, along with priors informed from earlier clinical trials. Secondary endpoints (KRT-free days and hospital-free days) were assessed using zero–one inflated beta regression. The posterior probability of benefit comparing an accelerated versus a standard KRT initiation strategy for the primary endpoint suggested no important difference, regardless of the prior used (absolute difference of 0.13% [95% credible interval [CrI] − 3.30% 3.40%], − 0.39% [95% CrI − 3.46% 3.00%], and 0.64% [95% CrI − 2.53% 3.88%] for neutral, optimistic, and pessimistic priors, respectively). There was a very low probability that the effect size was equal or larger than a consensus-defined minimal clinically important difference. Patients allocated to the accelerated strategy had a lower number of KRT-free days (median absolute difference of − 3.55 days [95% CrI − 6.38 − 0.48]), with a probability that the accelerated strategy was associated with more KRT-free days of 0.008. Hospital-free days were similar between strategies, with the accelerated strategy having a median absolute difference of 0.48 more hospital-free days (95% CrI − 1.87 2.72) compared with the standard strategy and the probability that the accelerated strategy had more hospital-free days was 0.66. In a Bayesian reanalysis of the STARRT-AKI trial, we found very low probability that an accelerated strategy has clinically important benefits compared with the standard strategy. Patients receiving the accelerated strategy probably have fewer days alive and KRT-free. These findings do not support the adoption of an accelerated strategy of KRT initiation.
Publisher: Elsevier BV
Date: 2012
DOI: 10.1093/BJA/AER424
Publisher: Springer Science and Business Media LLC
Date: 11-06-2018
Publisher: Springer Science and Business Media LLC
Date: 06-2015
DOI: 10.1007/S00134-015-3757-6
Abstract: To compare the effect of intensive versus conventional blood glucose control in patients with traumatic brain injury. In a large international randomized trial patients were randomly assigned to a target blood glucose (BG) range of either 4.5-6.0 mmol/L (intensive control) or <10 mmol/L (conventional control). Patients with traumatic brain injury (TBI) were identified at randomization and data were collected to examine the extended Glasgow outcome score (includes mortality) at 24 months. Of the 6104 randomized patients, 391 satisfied diagnostic criteria for TBI 203 (51.9%) were assigned to intensive and 188 (48.1%) to conventional control the primary outcome was available for 166 (81.8%) and 149 (79.3%) patients, respectively. The two groups had similar baseline characteristics. At 2 years 98 (58.7%) patients in the intensive group and 79 (53.0%) in the conventional group had a favorable neurological outcome (odds ratio [OR] 1.26, 95% CI 0.81-1.97 P = 0.3) 35 patients (20.9%) in the intensive group and 34 (22.8%) in the conventional group had died (OR 0.90, 95% CI 0.53-1.53 P = 0.7) moderate hypoglycemia (BG 2.3-3.9 mmol/L 41-70 mg/dL) occurred in 160/202 (79.2%) and 17/188 (9.0%), respectively (OR 38.3, 95% CI 21.0-70.1 P < 0.0001) severe hypoglycemia (BG ≤ 2.2 mmol/L ≤40 mg/dL) in 10 (4.9%) and 0 (0.0%), respectively (OR 20.5 95% CI 1.2-351.6, P = 0.003). Although patients with traumatic brain injury randomly assigned to intensive compared to conventional glucose control experienced moderate and severe hypoglycemia more frequently, we found no significant difference in clinically important outcomes.
Publisher: Springer Science and Business Media LLC
Date: 04-10-2018
DOI: 10.1038/S41581-018-0060-0
Abstract: Corrections: Fig. 1: 'MAP' inserted before '60-65 mmHg Fig. 3: 'Echocardiography' amended to 'Electrocardiographic'. Fig. 4b additions: two cell nuclei text labels 'Large pore transporting plasma proteins', 'Small pore network', 'Intercellular cleft' 'Intact' and 'Damaged' legend updated.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2012
Publisher: American Thoracic Society
Date: 02-2016
Publisher: Wiley
Date: 02-2019
DOI: 10.1111/IMJ.14199
Abstract: Sepsis, defined as life-threatening organ dysfunction due to a dysregulated host response to infection, is recognised by the World Health Organization as a global health priority. Each year, 5000 of the 18 000 adults with sepsis treated in Australian intensive care units die, with survivors suffering long-term physical, cognitive and psychological dysfunction, which is poorly recognised and frequently untreated. There are currently no effective pharmacological treatments for sepsis, making early recognition, resuscitation and immediate treatment with appropriate antibiotics the key to reducing the burden of resulting disease. The majority of sepsis, around 70-80%, is community acquired making emergency departments and primary care key targets to improve recognition and early management. Case fatality rates for sepsis are decreasing in many countries with the reduction attributed to national or regional screening and quality improvement programmes focused on early identification and immediate treatment. The optimum approach to treating established sepsis has been informed by high-quality, multicentre investigator initiated randomised trials with much of the valuable data coming from National Health and Medical Research Council-funded trials run from Australia. While early recognition and improved management of the acute episode are important steps in reducing death and disability from sepsis, a substantial reduction in the burden of sepsis-related disease requires action across the entire healthcare system. In this narrative review, we provide a summary of current knowledge on epidemiology of sepsis and septic shock and recommendations on the optimum approach to the management of these conditions in adults.
Publisher: Massachusetts Medical Society
Date: 22-10-2009
Publisher: Springer Science and Business Media LLC
Date: 19-04-2006
DOI: 10.1007/S00134-006-0135-4
Abstract: To document current management of blood glucose in Australian and New Zealand intensive care units (ICUs) and to investigate the association between insulin administration, blood glucose concentration and hospital outcome. Practice survey and inception cohort study in closed multi-disciplinary ICUs in Australia and New Zealand. Twenty-nine ICU directors and 939 consecutive admissions to 29 ICUs during a 2-week period. Data collected included unit approaches to blood glucose management, patient characteristics, blood glucose concentrations, insulin administration and patient outcomes. Ten percent of the ICU directors reported using an intensive insulin regimen in all their patients. In 861 patients (91.7%) blood glucose concentration was greater than 6.1[Symbol: see text]mmol/l, 287 (31.1%) received insulin, and the median blood glucose concentration triggering insulin administration was 11.5 (IQR 9.4-14) mmol/l. Univariate analysis demonstrated that non-survivors had a higher maximum daily blood glucose concentration (12 mmol/l, 9.4-14.8, vs. 9.5, 7.6-12.2) and were more likely to receive insulin (47% vs. 28%). Multiple logistic regression analysis showed age (OR per 5-year decrease 0.93, 95% CI 0.87-1.00) and APACHE II (OR per point decrease 0.87, 95% CI 0.84-0.90) to be independently associated with hospital mortality. After controlling for age and APACHE II both daily highest blood glucose (OR 0.95, 95% CI 0.90-1.00) and administration of insulin (OR 0.62, 95% CI 0.39-1.00) were independently associated when added to the model alone neither was independently associated when they were simultaneously included in the model. Few Australian and New Zealand ICUs have adopted intensive insulin therapy. In this study, insulin administration and highest daily blood glucose concentration could not be separated in their association with hospital mortality.
Publisher: Cold Spring Harbor Laboratory
Date: 20-03-2022
DOI: 10.1101/2022.03.18.22272586
Abstract: The use of Selective Decontamination of the Digestive Tract (SDD) as a preventative infection-control strategy in invasively ventilated patients in the intensive care unit (ICU) remains low despite numerous randomised controlled trials (RCTs) consistently reporting reductions in interval mortality rates and shorter durations of mechanical ventilation. The Selective Decontamination of the Digestive Tract in the Intensive Care Unit (SuDDICU) cluster cross-over RCT, that includes over 5500 participants randomised to receive a standardised commercial grade SDD interventions or standard care, will be reported in 2022 and will add substantive weight to previous RCT data assessing the effect of SDD on interval mortality compared to standard care. We will conduct an updated systematic review and prospective aggregate data meta-analysis of previous conducted and published RCTs, developed using a protocol and statistical analysis plan completed prior to the completion of the SuDDICU RCT and including the SuDDICU data to present the most current evidence available to guide clinical practice. We will include RCTs that compare the effect on hospital mortality and other patient-centred outcomes of treatment with SDD compared to standard care in invasively ventilated adults in the ICU. We will perform a search that includes the electronic databases MEDLINE and EMBASE and clinical trial registries. Two reviewers will independently screen titles and abstracts, perform full article reviews and extract study data, with discrepancies resolved by a third reviewer. We will report study characteristics and quantify risk of bias. We will perform random effects Bayesian meta-analyses to provide pooled estimates that SDD improves outcomes, whenever it is feasible to do so. We will evaluate overall certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation framework. This updated systematic review and prospective meta-analysis will provide clinicians with an expedited assessment of the totality of current evidence about the effect on mortality of using SDD in mechanically ventilated ICU patients.
Publisher: Mary Ann Liebert Inc
Date: 04-2013
Publisher: Elsevier BV
Date: 03-2014
DOI: 10.1093/BJA/AEU025
Publisher: Springer Science and Business Media LLC
Date: 07-01-2021
Publisher: Elsevier BV
Date: 11-2014
DOI: 10.1093/BJA/AEU141
Publisher: Elsevier BV
Date: 10-2012
DOI: 10.1016/J.TMRV.2011.11.003
Abstract: Severe sepsis and septic shock are the most common reasons for admission to an intensive care unit and the risk of death is substantial, estimated at approximately 40%. Evidence suggests that early resuscitation strategies that include the use of resuscitation fluids, antibiotics, blood, and inotropes reduce death. Although fluid resuscitation is an immediate life-saving intervention, a fundamental question that remains unanswered is whether the type of resuscitation fluid impacts survival when it is initiated very early in the course of septic shock. A randomized controlled trial published in 2008 confirmed that hydroxyethyl starch fluids cause acute renal failure defined by the requirement for renal replacement therapy. In contrast, a subgroup analysis from a randomized controlled trial suggests that 4% albumin fluid may reduce death from severe sepsis however, these findings require confirmation in a large randomized trial. Our team is planning a pragmatic early septic shock fluid resuscitation trial that will compare the effectiveness of 5% albumin vs normal saline on 90-day mortality (PRECISE). In this article, we summarize the scientific rationale and inherent challenges associated with the conduct of PRECISE, the background work and planning elements that have been undertaken, and the PRECISE RCT protocol with rationale and justifications provided for the chosen population, the interventions, and the outcome measures.
Publisher: Wiley
Date: 02-11-2017
Abstract: Sepsis has recently been redefined as acute organ dysfunction due to infection. The ED plays a critical role in identifying patients with sepsis. This is challenging due to the heterogeneity of the syndrome, and the lack of an objective standard diagnostic test. While overall mortality rates from sepsis appear to be falling, there is an increasing burden of morbidity among survivors. This largely reflects the growing proportion of older patients with comorbid illnesses among those treated for sepsis.
Publisher: Elsevier BV
Date: 04-2007
DOI: 10.1016/J.RESUSCITATION.2006.08.020
Abstract: To evaluate the ability of pre-defined clinical criteria to identify patients who subsequently suffer cardiac arrest, unplanned intensive care unit admission or unexpected death to determine the ability of modified criteria to identify these patients. Nested, matched case-control study. Seven Australian public hospitals. Four hundred and fifty cases and 520 controls matched for age, sex, hospital, and hospital ward. None. Highest and lowest respiratory and heart rates, lowest systolic blood pressure, presence of threatened airway, seizures or decrease in Glasgow Coma Scale score of greater than two points and incidence of the three adverse events were measured. Combining a heart rate greater than 140, respiratory rate greater than 36, a systolic blood pressure less than 90 mmHg and a greater than two point reduction in the Glasgow Coma Scale identified adverse events with a sensitivity of 49.1% (44.4-53.8%), specificity of 93.7% (91.2-95.6%), and positive predictive value of 9.8% (8.7-11.1%). Adding threatened airway, seizures, low respiratory rate and low heart rate did not substantially improve sensitivity (50.4% 45.7-55.2%). After modifying the cut-off values for respiratory rate, heart rate and systolic blood pressure, the best achievable positive predictive value remained below 16%. In combination, the respiratory rate, heart rate, systolic blood pressure, and level of consciousness identify patients at risk of cardiac arrest, unplanned intensive care admission or unexpected death with high specificity however the sensitivity and positive predictive value are relatively low, even after modification of the activation criteria cut-off values.
Publisher: Massachusetts Medical Society
Date: 20-09-2012
Publisher: BMJ
Date: 13-10-2011
DOI: 10.1136/INJURYPREV-2011-040216
Abstract: Injuries are a major source of mortality and morbidity in China with approximately 66 million citizens requiring emergency medical care. Trauma registries provide the basis for quality assurance processes and inform the treatment of the injured patient. Against the backdrop of the recently established Chinese National Injury Surveillance System, the feasibility of establishing a multicentre trauma registry in a limited number of hospitals was examined. Seven hospital directors reported on a range of hospital characteristics including patient volume information and the types of patient information routinely collected. The findings indicate significant numbers of patients presenting due to injury, though little comparability in the type of information collected both between hospitals and with international trauma registry systems. The development of multicentre trauma registry is suggested as a way to monitor trauma system performance. The integration of clinical indicators into the National Injury Surveillance System in the long term is also recommended.
Publisher: American College of Physicians
Date: 18-08-2009
Publisher: Springer Science and Business Media LLC
Date: 21-06-2011
Publisher: Elsevier
Date: 2009
Publisher: Springer Science and Business Media LLC
Date: 14-03-2013
Publisher: American Medical Association (AMA)
Date: 21-04-2020
Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
Date: 04-1999
DOI: 10.3171/JNS.1999.90.4.0695
Abstract: Object. The aim of this study was to analyze delayed neurological deficits following surgical resection of arteriovenous malformations (AVMs). Methods. The authors report on a consecutive series of 200 patients with angiographically proven AVMs of the brain that were surgically resected between January 1989 and June 1998. The 30-day mortality rate for patients in this series was 1%, with one death caused by AVM resection and one death attributed to basilar artery aneurysm repair following successful AVM resection. The Spetzler—Martin grading system correlated well with the difficulty of surgery. No permanent incidence of morbidity resulted from resection of Grade I or II AVMs the percentage of patients with a significant neurological deficit due to resection was 7.8% for those with Grade III lesions and 33.3% for those with Grade IV or V AVMs. However, this grading system did not accurately predict the development of delayed neurological deficits. Ten patients (5%) developed delayed neurological deficits after recovering from anesthesia and surgery. The delayed deficit was due to hemorrhage in four of the 10 patients and all four had undergone resection of AVMs measuring at least 4 cm in diameter. An increase in blood pressure during the first 8 postoperative days precipitated hemorrhage in these patients. Edema arising as a consequence of propagated venous thrombosis (two patients) was associated with extensive venous drainage networks rather than large AVM niduses. Both hemorrhagic and edematous complications can be included under the umbrella term of “arterial-capillary-venous hypertensive syndrome” to describe the common underlying pathogenesis accurately. An additional four patients developed a delayed deficit as a result of vasospasm. Vasospasm occurred when resection had involved extensive dissection of proximal anterior and middle cerebral arteries in such cases the incidence of vasospasm was 27%. Conclusions. On the basis of their analysis of these complications, the authors recommend strict blood pressure control for patients with lesions measuring 4 cm or more in diameter (particularly those with a deep arterial supply). Thromboprophylaxis with aspirin and heparin is prescribed for patients with extensive venous drainage networks, and prophylactic nimodipine therapy and angiographic surveillance for vasospasm are suggested for patients in whom extensive dissection of proximal anterior or middle cerebral arteries has been necessary.
Publisher: Springer Science and Business Media LLC
Date: 02-08-2018
DOI: 10.1038/S41581-018-0044-0
Abstract: Intravenous fluid therapy is one of the most common interventions in acutely ill patients. Each day, over 20% of patients in intensive care units (ICUs) receive intravenous fluid resuscitation, and more than 30% receive fluid resuscitation during their first day in the ICU. Virtually all hospitalized patients receive intravenous fluid to maintain hydration and as diluents for drug administration. Until recently, the amount and type of fluids administered were based on a theory described over 100 years ago, much of which is inconsistent with current physiological data and emerging knowledge. Despite their widespread use, various fluids for intravenous administration have entered clinical practice without a robust evaluation of their safety and efficacy. High-quality, investigator-initiated studies have revealed that some of these fluids have unacceptable toxicity as a result, several have been withdrawn from the market (while others, controversially, are still in use). The belief that dehydration and hypovolaemia can cause or worsen kidney and other vital organ injury has resulted in liberal approaches to fluid therapy and the view that fluid overload and tissue oedema are 'normal' during critical illness this is quite possibly harming patients. Increasing evidence indicates that restrictive fluid strategies might improve outcomes.
Publisher: Springer Science and Business Media LLC
Date: 15-03-2018
Publisher: Springer Science and Business Media LLC
Date: 04-2013
DOI: 10.1186/CC12591
Publisher: Massachusetts Medical Society
Date: 30-08-2007
DOI: 10.1056/NEJMOA067514
Publisher: Massachusetts Medical Society
Date: 28-10-2004
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2013
Publisher: Elsevier BV
Date: 12-2017
Publisher: Elsevier BV
Date: 2010
Publisher: BMJ
Date: 18-03-2010
DOI: 10.1136/BMJ.C1279
Abstract: To describe the epidemiology of 2009 A/H1N1 influenza in critically ill pregnant women. Population based cohort study. All intensive care units in Australia and New Zealand. All women with 2009 H1N1 influenza who were pregnant or recently post partum and admitted to an intensive care unit in Australia or New Zealand between 1 June and 31 August 2009. Maternal and neonatal mortality and morbidity. 64 pregnant or postpartum women admitted to an intensive care unit had confirmed 2009 H1N1 influenza. Compared with non-pregnant women of childbearing age, pregnant or postpartum women with 2009 H1N1 influenza were at increased risk of admission to an intensive care unit (relative risk 7.4, 95% confidence interval 5.5 to 10.0). This risk was 13-fold greater (13.2, 9.6 to 18.3) for women at 20 or more weeks' gestation. At the time of admission to an intensive care unit, 22 women (34%) were post partum and two had miscarried. 14 women (22%) gave birth during their stay in intensive care and 26 (41%) were discharged from an intensive care unit with ongoing pregnancy. All subsequently delivered. 44 women (69%) were mechanically ventilated. Of these, nine (14%) were treated with extracorporeal membrane oxygenation. Seven women (11%) died. Of 60 births after 20 weeks' gestation, four were stillbirths and three were infant deaths. 22 (39%) of the liveborn babies were preterm and 32 (57%) were admitted to a neonatal intensive care unit. Of 20 babies tested, two were positive for the 2009 H1N1 virus. Pregnancy is a risk factor for critical illness related to 2009 H1N1 influenza, which causes maternal and neonatal morbidity and mortality.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 16-08-2021
Publisher: S. Karger AG
Date: 2009
DOI: 10.1159/000195091
Abstract: i Background and Objectives: /i Aspects of trial design, screening and study efficiency can affect recruitment and the findings of the trial itself. A clear understanding of the screening and study inclusion process will assist clinicians in interpreting trial results. i Design: /i Prospective observational data collection on all patients screened for possible inclusion in a randomized controlled trial of normal vs. augmented renal replacement therapy in critically ill patients (the RENAL Trial). i Setting: /i 35 hospitals in Australia and New Zealand. i Participants: /i All patients screened for the RENAL Trial. i Results: /i We screened 4,551 patients. Of these patients, 767 were ineligible because of lack of inclusion criteria and 2,085 because of exclusion criteria. Of the remaining 1,699, 1,508 (88.7%) were enrolled. The three most common exclusion criteria which prevented recruitment of potentially eligible patients were that the patient had end-stage kidney failure and was already on chronic dialysis (484 23.2%), the patient’s body weight was either or kg (456 21.8%), and the fact that the patient had already received renal replacement therapy during the index admission. Important modifiable impediments to recruitment were inability to obtain consent in 191 cases, unavailability of research staff in 124 cases, physician objection in 89 cases, and inability to deliver the trial protocol in 78 cases. i Conclusion: /i The RENAL Trial’s enrolment efficiency was high and compared favourably with previous large intensive care units trials and with that of trials in patients with acute renal failure. The high rate of enrolment suggests that the results can be applied with confidence to most patients with de novo acute renal failure. The loss of close to 1.5% of patients due to consent issues highlights a common problem in critical care trials. The low rate of physician objection suggests clinical equipoise.
Publisher: Springer Science and Business Media LLC
Date: 06-10-2010
DOI: 10.1007/S00134-010-2039-6
Abstract: To determine the effect of random assignment to fluid resuscitation with albumin or saline on organ function and mortality in patients with severe sepsis. Pre-defined subgroup analysis of a randomized controlled trial conducted in the intensive care units of 16 hospitals in Australia and New Zealand. Of 1,218 patients with severe sepsis at baseline, 603 and 615 were assigned to receive albumin and saline, respectively. The two groups had similar baseline characteristics. During the first 7 days mean arterial pressure was similar in the two groups, but patients assigned albumin had a lower heart rate on days 1 and 3 (p = 0.002 and p = 0.03, respectively) and a higher central venous pressure on days 1-3 (p < 0.005 each day). There was no difference in the renal or total Sequential Organ Failure Assessment score of the two groups 113/603 (18.7%) of patients assigned albumin were treated with renal replacement therapy compared to 112/615 (18.2%) assigned saline (p = 0.98). The unadjusted relative risk of death for albumin versus saline was 0.87 [95% confidence interval (CI) 0.74-1.02] for patients with severe sepsis and 1.05 (0.94-1.17) for patients without severe sepsis (p = 0.06 for heterogeneity). From multivariate logistic regression analysis adjusting for baseline factors in patients with complete baseline data (919/1,218, 75.5%), the adjusted odds ratio for death for albumin versus saline was 0.71 (95% CI: 0.52-0.97 p = 0.03). Administration of albumin compared to saline did not impair renal or other organ function and may have decreased the risk of death.
Publisher: Elsevier
Date: 2014
Publisher: American Medical Association (AMA)
Date: 15-11-2022
Abstract: Whether selective decontamination of the digestive tract (SDD) reduces mortality in critically ill patients remains uncertain. To determine whether SDD reduces in-hospital mortality in critically ill adults. A cluster, crossover, randomized clinical trial that recruited 5982 mechanically ventilated adults from 19 intensive care units (ICUs) in Australia between April 2018 and May 2021 (final follow-up, August 2021). A contemporaneous ecological assessment recruited 8599 patients from participating ICUs between May 2017 and August 2021. ICUs were randomly assigned to adopt or not adopt a SDD strategy for 2 alternating 12-month periods, separated by a 3-month interperiod gap. Patients in the SDD group (n = 2791) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n = 3191) received standard care. The primary outcome was in-hospital mortality within 90 days. There were 8 secondary outcomes, including the proportion of patients with new positive blood cultures, antibiotic-resistant organisms (AROs), and Clostridioides difficile infections. For the ecological assessment, a noninferiority margin of 2% was prespecified for 3 outcomes including new cultures of AROs. Of 5982 patients (mean age, 58.3 years 36.8% women) enrolled from 19 ICUs, all patients completed the trial. There were 753/2791 (27.0%) and 928/3191 (29.1%) in-hospital deaths in the SDD and standard care groups, respectively (mean difference, −1.7% [95% CI, −4.8% to 1.3%] odds ratio, 0.91 [95% CI, 0.82-1.02] P = .12). Of 8 prespecified secondary outcomes, 6 showed no significant differences. In the SDD vs standard care groups, 23.1% vs 34.6% had new ARO cultures (absolute difference, −11.0% 95% CI, −14.7% to −7.3%), 5.6% vs 8.1% had new positive blood cultures (absolute difference, −1.95% 95% CI, −3.5% to −0.4%), and 0.5% vs 0.9% had new C difficile infections (absolute difference, −0.24% 95% CI, −0.6% to 0.1%). In 8599 patients enrolled in the ecological assessment, use of SDD was not shown to be noninferior with regard to the change in the proportion of patients who developed new AROs (−3.3% vs −1.59% mean difference, −1.71% [1-sided 97.5% CI, −∞ to 4.31%] and 0.88% vs 0.55% mean difference, −0.32% [1-sided 97.5% CI, −∞ to 5.47%]) in the first and second periods, respectively. Among critically ill patients receiving mechanical ventilation, SDD, compared with standard care without SDD, did not significantly reduce in-hospital mortality. However, the confidence interval around the effect estimate includes a clinically important benefit. ClinicalTrials.gov Identifier: NCT02389036
Publisher: American Medical Association (AMA)
Date: 22-05-2013
Abstract: Systematic reviews suggest adult patients in intensive care units (ICUs) with relative contraindications to early enteral nutrition (EN) may benefit from parenteral nutrition (PN) provided within 24 hours of ICU admission. To determine whether providing early PN to critically ill adults with relative contraindications to early EN alters outcomes. Multicenter, randomized, single-blind clinical trial conducted between October 2006 and June 2011 in ICUs of 31 community and tertiary hospitals in Australia and New Zealand. Participants were critically ill adults with relative contraindications to early EN who were expected to remain in the ICU longer than 2 days. Random allocation to pragmatic standard care or early PN. Day-60 mortality quality of life, infections, and body composition. A total of 1372 patients were randomized (686 to standard care, 686 to early PN). Of 682 patients receiving standard care, 199 patients (29.2%) initially commenced EN, 186 patients (27.3%) initially commenced PN, and 278 patients (40.8%) remained unfed. Time to EN or PN in patients receiving standard care was 2.8 days (95% CI, 2.3 to 3.4). Patients receiving early PN commenced PN a mean of 44 minutes after enrollment (95% CI, 36 to 55). Day-60 mortality did not differ significantly (22.8% for standard care vs 21.5% for early PN risk difference, -1.26% 95% CI, -6.6 to 4.1 P = .60). Early PN patients rated day-60 quality of life (RAND-36 General Health Status) statistically, but not clinically meaningfully, higher (45.5 for standard care vs 49.8 for early PN mean difference, 4.3 95% CI, 0.95 to 7.58 P = .01). Early PN patients required fewer days of invasive ventilation (7.73 vs 7.26 days per 10 patient × ICU days, risk difference, -0.47 95% CI, -0.82 to -0.11 P = .01) and, based on Subjective Global Assessment, experienced less muscle wasting (0.43 vs 0.27 score increase per week mean difference, -0.16 95% CI, -0.28 to -0.038 P = .01) and fat loss (0.44 vs 0.31 score increase per week mean difference, -0.13 95% CI, -0.25 to -0.01 P = .04). The provision of early PN to critically ill adults with relative contraindications to early EN, compared with standard care, did not result in a difference in day-60 mortality. The early PN strategy resulted in significantly fewer days of invasive ventilation but not significantly shorter ICU or hospital stays. anzctr.org.au Identifier: ACTRN012605000704695.
Publisher: Elsevier BV
Date: 2010
DOI: 10.1016/J.RESUSCITATION.2009.09.025
Abstract: To examine interventions and timing of emergency team calls in hospitals with or without a medical emergency team (MET). Interventions were recorded, categorized and classified as critical care interventions (e.g. airway intervention, ventilation and use of inotropic drugs) ward level interventions (e.g. fluids, oxygen by mask) assessment, physical examination and investigations. Only 5 of the 2376 calls were free of critical care interventions. For non-cardiac arrest-related calls, MET hospitals had a lower proportion of airway, circulation and drug-related interventions and a higher proportion of ward level interventions. The majority of calls were between 0601 and 1200 h and cardiac arrest survival was greatest in the 1200-2400 h period. Overall median time at the scene was 25 min. Nearly all emergency team calls required critical care type interventions. Emergency team calls show a unique temporal pattern for both MET and control hospitals. These findings have important organizational and resource-related implications for hospitals evaluating and establishing rapid response systems.
Publisher: Springer Science and Business Media LLC
Date: 18-10-2023
Publisher: Center for Open Science
Date: 25-05-2023
Abstract: FluDReSS is an open label randomised controlled clinical trial of three different dosing regimens of fludrocortisone in critically ill patients with septic shock compared to no fludrocortisone. The primary objective is to determine whether the combination of hydrocortisone plus fludrocortisone compared to hydrocortisone alone reduces time to shock reversal. This detailed statistical analysis plan (SAP) was written by the trial statistician and study investigators prior to unblinding.
Publisher: Springer Science and Business Media LLC
Date: 24-06-2004
DOI: 10.1007/S00134-004-2360-Z
Abstract: To examine the incidence and predictors of clinician discomfort with life support plans for ICU patients. Prospective cohort in 13 medical-surgical ICUs in four countries. 657 mechanically ventilated adults expected to stay in ICU at least 72 h. Daily we documented the life support plan for mechanical ventilation, inotropes and dialysis, and clinician comfort with these plans. If uncomfortable, clinicians stated whether the plan was too technologically intense (the provision of too many life support modalities or the provision of any modality for too long) or not intense enough, and why. At least one clinician was uncomfortable at least once for 283 (43.1%) patients, primarily because plans were too technologically intense rather than not intense enough (93.9% vs. 6.1%). Predictors of discomfort because plans were too intense were: patient age, medical admission, APACHE II score, poor prior functional status, organ dysfunction, dialysis in ICU, plan to withhold dialysis, plan to withhold mechanical ventilation, first week in the ICU, clinician, and city. Clinician discomfort with life support perceived as too technologically intense is common, experienced mostly by nurses, variable across centers, and is more likely for older, severely ill medical patients, those with acute renal failure, and patients lacking plans to forgo reintubation and ventilation. Acknowledging the sources of discomfort could improve communication and decision making.
Publisher: American Medical Association (AMA)
Date: 03-10-2017
Publisher: Springer Science and Business Media LLC
Date: 07-10-2008
Publisher: Springer Science and Business Media LLC
Date: 10-2015
Publisher: S. Karger AG
Date: 2014
DOI: 10.1159/000363175
Abstract: b i Background and Aims: /i /b We aimed to examine the association between daily b /b rotein intake (DPI) and outcomes in patients from the Randomized Evaluation of Normal versus Augmented Level (RENAL) trial. b i Methods: /i /b We analyzed the association between DPI and clinical outcomes using multivariable logistic regression, Cox proportional hazards models and time-adjusted analysis. b i Results: /i /b During ICU stay, mean DPI was 37.6 g/day among survivors and 37.7 g/day among nonsurvivors (p = 0.96 DPI of 0.5 g/kg/day). Only 159 (10.9%) of the patients received a mean DPI of g/kg. Patients with a DPI above the median had a 43.1% mortality compared with 46.1% for a DPI below the median (p = 0.25). On multivariate analysis, a lower DPI was not associated with increased odds ratios for 90-day mortality or any secondary outcomes. Cox proportional hazards models and time-adjusted analysis confirmed these findings. b i Conclusions: /i /b In the RENAL study, mean DPI was low. Within the confines of such low DPI, greater amounts of DPI were not independently associated with improved clinical outcomes. Video Journal Club “Cappuccino with Claudio Ronco” at www.karger.com/?doi=363175.
Publisher: GN1 Genesis Network
Date: 2021
Publisher: King Faisal Specialist Hospital and Research Centre
Date: 11-2016
Publisher: Springer Science and Business Media LLC
Date: 03-03-2023
DOI: 10.1186/S13054-023-04333-9
Abstract: This study assessed the mobility levels among critically ill patients and the association of early mobility with incident proximal lower-limb deep-vein thrombosis and 90-day mortality. This was a post hoc analysis of the multicenter PREVENT trial, which evaluated adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis with an expected ICU stay ≥ 72 h and found no effect on the primary outcome of incident proximal lower-limb deep-vein thrombosis. Mobility levels were documented daily up to day 28 in the ICU using a tool with an 8-point ordinal scale. We categorized patients according to mobility levels within the first 3 ICU days into three groups: early mobility level 4–7 (at least active standing), 1–3 (passive transfer from bed to chair or active sitting), and 0 (passive range of motion). We evaluated the association of early mobility and incident lower-limb deep-vein thrombosis and 90-day mortality by Cox proportional models adjusting for randomization and other co-variables. Of 1708 patients, only 85 (5.0%) had early mobility level 4–7 and 356 (20.8%) level 1–3, while 1267 (74.2%) had early mobility level 0. Patients with early mobility levels 4–7 and 1–3 had less illness severity, femoral central venous catheters, and organ support compared to patients with mobility level 0. Incident proximal lower-limb deep-vein thrombosis occurred in 1/85 (1.3%) patients in the early mobility 4–7 group, 7/348 (2.0%) patients in mobility 1–3 group, and 50/1230 (4.1%) patients in mobility 0 group. Compared with early mobility group 0, mobility groups 4–7 and 1–3 were not associated with differences in incident proximal lower-limb deep-vein thrombosis (adjusted hazard ratio [aHR] 1.19, 95% confidence interval [CI] 0.16, 8.90 p = 0.87 and 0.91, 95% CI 0.39, 2.12 p = 0.83, respectively). However, early mobility groups 4–7 and 1–3 had lower 90-day mortality (aHR 0.47, 95% CI 0.22, 1.01 p = 0.052, and 0.43, 95% CI 0.30, 0.62 p 0.0001, respectively). Only a small proportion of critically ill patients with an expected ICU stay ≥ 72 h were mobilized early. Early mobility was associated with reduced mortality, but not with different incidence of deep-vein thrombosis. This association does not establish causality, and randomized controlled trials are required to assess whether and to what extent this association is modifiable. The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).
Publisher: Springer Science and Business Media LLC
Date: 06-08-2010
Publisher: Journal of Neurosurgery Publishing Group (JNSPG)
Date: 12-2003
DOI: 10.3171/JNS.2003.99.6.0967
Abstract: Object. Between 1989 and 2002 the authors treated 416 cases of angiographically confirmed arteriovenous malformations (AVMs) of the brain. Methods. Three hundred fifty-five patients underwent resection of an AVM 2% died and 12% experienced a permanent morbidity (1.7% experienced a deterioration of modified Rankin Scale [mRS] score of 3–5). Patient outcomes in this series were based on the Spetzler—Martin grade. For patients with Grade I and II AVMs the rate of permanent morbidity was 1% and the rate of mortality was 0.5%. For patients with Grade III AVMs the morbidity rate was 18.9% (2.7% experienced a deterioration of mRS score of 3–5) and the mortality rate was 2.7%. For patients with Grade IV and V AVMs the morbidity rate was 25.6% (5.1% experienced a deterioration of mRS score of 3–5) and the mortality rate was 7.7%. No patient with a Spetzler—Martin Grade I or II lesion had a worsened outcome due to delayed hemorrhage, whereas 3.6% of patients with a Grade III and 12.8% of patients with Grade IV and V AVMs experienced delayed hemorrhage that led to a permanent downgrade in function. With the introduction of an aggressive postoperative blood pressure protocol (for AVMs with grades II and sizes 3.5 cm in diameter) the incidence of delayed postoperative hemorrhage leading to mortality or permanent morbidity decreased from 4.4 to 1%. This difference was significant. Neither case selection nor complications other than delayed hemorrhage changed between these two periods. Conclusions. In selected cases an aggressive postoperative blood pressure protocol is likely to reduce delayed hemorrhage following AVM resection.
Publisher: BMJ
Date: 14-09-1996
Abstract: In recent years, a variety of new antibody formats have been developed. One of these formats allows the binding of one type of antibody to two different epitopes. This can for ex le be achieved by introduction of the "knob-into-hole" format and a combined CrossMab approach. Due to their complexity, these bispecific antibodies are expected to result in an enhanced variety of different degradation products. Reports on the stability of these molecules are still largely lacking. To address this, a panel of stress conditions, including elevated temperature, pH, oxidizing agents, and forced glycation via glucose incubation, to identify and functionally evaluate critical quality attributes in the complementary-determining and conserved regions of a bispecific antibody was applied in this study. The exertion of various stress conditions combined with an assessment by size exclusion chromatography, ion exchange chromatography, LC-MS/MS peptide mapping, and functional evaluation by cell-based assays was adequate to identify chemical modification sites and assess the stability and integrity, as well as the functionality of a bispecific antibody. Stress conditions induced size variants and post-translational modifications, such as isomerization, deamidation, and oxidation, albeit to a modest extent. Of note, all the observed stress conditions largely maintained functionality. In summary, this study revealed the pronounced stability of IgG1 "knob-into-hole" bispecific CrossMab antibodies compared to already marketed antibody products.
Publisher: Springer Science and Business Media LLC
Date: 25-11-2010
Publisher: AMPCo
Date: 11-2002
DOI: 10.5694/J.1326-5377.2002.TB04950.X
Abstract: To determine the incidence and appropriateness of use of allogenic packed red blood cell (RBC) transfusion in Australian and New Zealand intensive care practice. Intensive care units of 18 Australian and New Zealand hospitals: March 2001. Prospective, observational, multicentre study. All admissions to participating intensive care units were screened and all patients who received a transfusion of RBC were enrolled. The indications for transfusion were recorded and compared with Australian National Health and Medical Research Council guidelines. Transfusions conforming to these guidelines were deemed appropriate. RBC transfusion in intensive care and transfusion appropriateness. 1808 admissions to intensive care units were screened: 357 (19.8%) admissions (350 patients) received an RBC transfusion while in intensive care. Overall, 1464 RBC units were administered in intensive care on 576 transfusion days. The most common indications for transfusion were acute bleeding (60.1% 880/1464) and diminished physiological reserve (28.9% 423/1464). The rate of inappropriate transfusion was 3.0% (44/1464). Diminished physiological reserve with haemogloblin level > or = 100 g/L was the indication in 50% (22/44) of inappropriate transfusions no indication was provided for 31% (15/44). The rate of inappropriate transfusion in Australian and New Zealand intensive care units in 2001 was remarkably low.
Publisher: Springer Science and Business Media LLC
Date: 27-05-2008
DOI: 10.1007/S00134-008-1160-2
Abstract: To compare the time course of organ dysfunction/failure, mortality and cause of death in patients with severe sepsis (SS) and patients with severe non-infectious systemic inflammatory response syndrome (SNISIRS). Secondary analysis of a multi-centre inception cohort study. Twenty-three multidisciplinary intensive care units (ICUs) in Australia and New Zealand. 3,543 ICU admissions > or = 48 h or <48 h if SIRS and organ dysfunction present. None. ICU prevalence of SS and SNISIRS was 20% (707/3,543) and 28% (980/3,543), respectively. ICU mortality was similar in patients with SNISIRS and with SS (25 vs. 27%, P = 0.40). Central nervous system (CNS) failure occurred more frequently in patients with SNISIRS (33 vs. 22%, P < 0.001) and resulted in death more commonly than in SS (relative risk = 1.6, 95% confidence interval 1.4-1.7, P < 0.001). The time to peak organ dysfunction (0.67 vs. 0.91 days, P = 0.004), overall episode length (3.6 vs. 5.6 days, P < 0.001) and ICU stay (geometric mean: 4.1 vs. 5.8 days, P < 0.001) were significantly shorter in patients with SNISIRS. Whilst SNISIRS and SS have similarities, including their crude mortality rate, important differences exist. SNISIRS is more common on admission to the ICU, and is more commonly coupled with CNS dysfunction and death from neurological failure. SIRS/sepsis: clinical studies.
Publisher: Elsevier BV
Date: 03-2020
DOI: 10.51893/2020.2.OA3
Abstract: BACKGROUND: Contemporary glucose management of intensive care unit (ICU) patients with type 2 diabetes is based on trial data derived predominantly from patients without type 2 diabetes. This is despite the recognition that patients with type 2 diabetes may be relatively more tolerant of hyperglycaemia and more susceptible to hypoglycaemia. It is uncertain whether glucose targets should be more liberal in patients with type 2 diabetes. OBJECTIVE: To detail the protocol, analysis and reporting plans for a randomised clinical trial — the Liberal Glucose Control in Critically Ill Patients with Pre-existing Type 2 Diabetes (LUCID) trial — which will evaluate the risks and benefits of targeting a higher blood glucose range in patients with type 2 diabetes. DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A multicentre, parallel group, open label phase 2B randomised controlled clinical trial of 450 critically ill patients with type 2 diabetes. Patients will be randomised 1:1 to liberal blood glucose (target 10.0–14.0 mmol/L) or usual care (target 6.0–10.0 mmol/L). MAIN OUTCOME MEASURES: The primary endpoint is incident hypoglycaemia ( 4.0 mmol/L) during the study intervention. Secondary endpoints include biochemical and feasibility outcomes. RESULTS AND CONCLUSION: The study protocol and statistical analysis plan described will delineate conduct and analysis of the trial, such that analytical and reporting bias are minimised. TRIAL REGISTRATION: This trial has been registered on the Australian New Zealand Clinical Trials Registry (ACTRN No. 12616001135404) and has been endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group.
Publisher: Elsevier BV
Date: 12-2000
DOI: 10.1016/S0140-6736(00)03495-4
Abstract: Low-dose dopamine is commonly administered to critically ill patients in the belief that it reduces the risk of renal failure by increasing renal blood flow. However, these effects have not been established in a large randomised controlled trial, and use of dopamine remains controversial. We have done a multicentre, randomised, double-blind, placebo-controlled study of low-dose dopamine in patients with at least two criteria for the systemic inflammatory response syndrome and clinical evidence of early renal dysfunction (oliguria or increase in serum creatinine concentration). 328 patients admitted to 23 participating intensive-care units (ICUs) were randomly assigned a continuous intravenous infusion of low-dose dopamine (2 microg kg(-1) min(-1)) or placebo administered through a central venous catheter while in the ICU. The primary endpoint was the peak serum creatinine concentration during the infusion. Analyses excluded four patients with major protocol violations. The groups assigned dopamine (n=161) and placebo (n=163) were similar in terms of baseline characteristics, renal function, and duration of trial infusion. There was no difference between the dopamine and placebo groups in peak serum creatinine concentration during treatment (245 [SD 144] vs 249 [147] micromol/L p=0.93), in the increase from baseline to highest value during treatment (62 [107] vs 66 [108] micromol/L p=0.82), or in the numbers of patients whose serum creatinine concentration exceeded 300 micromol/L (56 vs 56 p=0.92) or who required renal replacement therapy (35 vs 40 p=0.55). Durations of ICU stay (13 [14] vs 14 [15] days p=0.67) and of hospital stay (29 [27] vs 33 [39] days p=0.29) were also similar. There were 69 deaths in the dopamine group and 66 in the placebo group. Administration of low-dose dopamine by continuous intravenous infusion to critically ill patients at risk of renal failure does not confer clinically significant protection from renal dysfunction.
Publisher: Springer Science and Business Media LLC
Date: 19-12-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-2019
DOI: 10.1097/ALN.0000000000002955
Abstract: Two recent randomized controlled trials (Adjunctive Glucocorticoid Therapy in Patients with Septic Shock [ADRENAL] and Activated Protein C and Corticosteroids for Human Septic Shock [APROCCHSS]) of corticosteroids in patients with septic shock reported different treatment effects on 90-day mortality. Both trials enrolled patients who met the criteria for septic shock using the second international consensus definitions for sepsis and septic shock (Sepsis-2), but the APROCCHSS trial mandated a greater severity of shock as an inclusion criterion. The authors conducted post hoc sensitivity analyses of the ADRENAL trial to determine the effects of hydrocortisone versus placebo in subgroups selected using third international consensus definitions for sepsis and septic shock (Sepsis-3) diagnostic criteria or APROCCHSS inclusion criteria. There were 1,950 subjects (973 hydrocortisone and 977 placebo) who met the Sepsis-3 criteria (ADRENAL–Sepsis-3 cohort) and 905 patients (455 hydrocortisone and 450 placebo) who met the APROCCHSS criteria (ADRENAL–APROCCHSS cohort). At 90 days after randomization, in the ADRENAL–Sepsis-3 cohort, 312 of 963 (32.4%) and 337 of 958 (35.2%) patients assigned to hydrocortisone and placebo, respectively, had died (odds ratio, 0.86 95% CI, 0.70 to 1.06 P = 0.166). The corresponding figures for the ADRENAL–APROCCHSS cohorts were 187 of 453 (41.3%) and 200 of 445 (44.9%), respectively (odds ratio, 0.84 95% CI, 0.60 to 1.17 P = 0.303). There was no statistically significant difference in the time to death between the groups during the 90 days after randomization (hazard ratio = 0.87 95% CI, 0.75 to 1.02 P = 0.082 for ADRENAL–Sepsis-3 and hazard ratio = 0.86 95% CI, 0.71 to 1.06 P = 0.156 for ADRENAL–APROCCHSS cohorts). In both cohorts, patients assigned to hydrocortisone had faster resolution of shock. In the ADRENAL–Sepsis-3 cohort, patients assigned to hydrocortisone had an increase in the number of days alive and free of mechanical ventilation (57.0 ± 37.2 vs. 53.7 ± 38.2 days 95% CI, 0.40 to 7.04 P = 0.028) and the number of days alive and free of the intensive care unit (54.3 ± 36.0 vs. 51.0 ± 37.1 95% CI, 0.82 to 7.24 P = 0.014). In a post hoc analysis of the ADRENAL trial participants who fulfilled either the Sepsis-3 or the APROCCHSS inclusion criteria, a continuous infusion of hydrocortisone did not result in a lower 90-day mortality than placebo in septic shock.
Publisher: Massachusetts Medical Society
Date: 27-05-2004
DOI: 10.1056/NEJMOA040232
Publisher: Public Library of Science (PLoS)
Date: 11-02-2014
Publisher: BMJ
Date: 1994
DOI: 10.1136/THX.49.1.90
Abstract: The case is reported of a 28 year old woman with status asthmaticus unresponsive to three days of maximal medical treatment. Resolution of bronchospasm was achieved with an infusion of the intravenous anaesthetic agent ketamine.
Publisher: Springer Science and Business Media LLC
Date: 14-02-2013
DOI: 10.1007/S00134-013-2840-0
Abstract: To determine whether fluid resuscitation of acutely ill adults with 6 % hydroxyethyl starch (6 % HES 130) with a molecular weight of 130 kD and a molar substitution ratio of approximately 0.4 (6 % HES 130) compared with other resuscitation fluids results in a difference in the relative risk of death or treatment with renal replacement therapy (RRT). Systematic review and meta-analysis of randomized controlled trials comparing intravascular fluids for resuscitation of hospitalised adults that reported mortality or treatment with RRT. The risk of bias was assessed independently by two reviewers and meta-analysis was performed using random effects. Thirty-five trials enrolling 10,391 participants were included. The three largest trials had the lowest risk of bias, were published (or completed) in 2012, and together enrolled 77 % of all participants. Death occurred in 928 of 4,691 patients (19.8 %) in the 6 % HES 130 group versus 871 of 4,720 (18.5 %) in the control fluid groups relative risk (RR) in the 6 % HES 130 group 1.08, 95 % confidence interval (CI) 1.00 to 1.17, I (2) = 0 %). Treatment with RRT occurred in 378 of 4,236 patients (8.9 %) in the 6 % HES 130 group versus 306 of 4,260 (7.2 %) in the control fluid group (RR in the 6 % HES 130 group 1.25, 95 % CI 1.08 to 1.44, I (2) = 0 %). The quality and quantity of data evaluating 6 % hydroxyethyl starch (130/0.4 and 130/0.42) as a resuscitation fluid has increased in the last 12 months. Patients randomly assigned to resuscitation with 6 %HES 130 are at significantly increased risk of being treated with RRT.
Publisher: S. Karger AG
Date: 22-11-2017
DOI: 10.1159/000480224
Abstract: b i Aims: /i /b To study the association between higher versus lower continuous renal replacement therapy (CRRT) intensity and mortality in critically ill patients with combined acute kidney injury and liver dysfunction. b i Methods: /i /b Post-hoc analysis of patients with liver dysfunction (Sequential Organ Failure Assessment liver score ≥2 or diagnosis of liver failure/transplant) included in the Randomized Evaluation of Normal versus Augmented Level renal replacement therapy (RENAL) trial. b i Results: /i /b Of 444 patients, 210 (47.3%) were randomized to higher intensity (effluent flow 40 mL/kg/h) and 234 (52.7%) to lower intensity (effluent flow 25 mL/kg/h) therapy. Overall, 79 and 86% of prescribed effluent flow was delivered in the higher-intensity and lower-intensity groups, respectively ( i /i 0.001). In total, 113 (54.1%) and 120 (51.3%) patients died in each group. On multivariable Cox regression analysis, we found no independent association between higher CRRT intensity and mortality (HR 0.93, 95% CI 0.70-1.24 i /i = 0.642). b i Conclusions: /i /b In RENAL patients with liver dysfunction, higher CRRT intensity was not associated with reduced mortality.
Publisher: SAGE Publications
Date: 12-1998
DOI: 10.1177/0310057X9802600606
Abstract: A prospective standardized collection of clinical, microbiological and pharmaceutical information on antibiotic use was conducted in Australia and New Zealand intensive care units (ICUs) involving 481 consecutive critically ill patients who were receiving antibiotics for any reason while in ICU. Patients had a mean SAPS II score of 34.1 ±17.8 with an expected mortality of 15.6% (actual mortality 12%). Of these, 292 (60.8%) were admitted to the ICU within 72 hours of surgery. Among such surgical patients, 233 (79.9%) received antibiotics for “surgical prophylaxis” while in ICU (48% of s le population). The second largest group of patients treated with antibiotics in ICU included those with systemic inflammatory response syndrome and clinical suspicion of infection (38%). Antibiotics were prescribed for the treatment of clinically diagnosed infection in 268 patients. Clinical response was apparent in 62.6%) and in most (71%) was achieved in the first 72 hours of treatment. The incidence of antimicrobial-related side-effects was 4%, mostly in the form of diarrhoea or rash (75%o of all side-effects). The most commonly prescribed antimicrobials were gentamicin (n = 146), ceftriaxone (n=98), vancomycin (n = 94) and metronidazole (n = 111). Three times daily prescription of aminoglycosides was uncommon ( %). Forty-one patients had a documented infection (positive culture) with a gram-negative organism. Of these, 17 received therapy with a single antibiotic and 24 received therapy with two antibiotics. Despite similar illness severity, there were six deaths in the former group and only two in the latter.
Publisher: Springer Science and Business Media LLC
Date: 20-05-2022
DOI: 10.1038/S41598-022-12336-9
Abstract: There are contradictory data regarding the effect of intermittent pneumatic compression (IPC) on the incidence of deep-vein thrombosis (DVT) and heart failure (HF) decompensation in critically ill patients. This study evaluated the effect of adjunctive use of IPC on the rate of incident DVT and ventilation-free days among critically ill patients with HF. In this pre-specified secondary analysis of the PREVENT trial (N = 2003), we compared the effect of adjunctive IPC added to pharmacologic thromboprophylaxis (IPC group), with pharmacologic thromboprophylaxis alone (control group) in critically ill patients with HF. The presence of HF was determined by the treating teams according to local practices. Patients were stratified according to preserved (≥ 40%) versus reduced ( 40%) left ventricular ejection fraction, and by the New York Heart Association (NYHA) classification. The primary outcome was incident proximal lower-limb DVT, determined with twice weekly venous Doppler ultrasonography. As a co-primary outcome, we evaluated ventilation-free days as a surrogate for clinically important HF decompensation. Among 275 patients with HF, 18 (6.5%) patients had prevalent proximal lower-limb DVT (detected on trial day 1 to 3). Of 257 patients with no prevalent DVT, 11/125 (8.8%) patients in the IPC group developed incident proximal lower-limb DVT compared to 6/132 (4.5%) patients in the control group (relative risk, 1.94 95% confidence interval, 0.74–5.08, p = 0.17). There was no significant difference in ventilator-free days between the IPC and control groups (median 21 days versus 25 days respectively, p = 0.17). The incidence of DVT with IPC versus control was not different across NYHA classes ( p value for interaction = 0.18), nor across patients with reduced and preserved ejection fraction ( p value for interaction = 0.15). Ventilator-free days with IPC versus control were also not different across NYHA classes nor across patients with reduced or preserved ejection fraction. In conclsuion, the use of adjunctive IPC compared with control was associated with similar rate of incident proximal lower-limb DVT and ventilator-free days in critically ill patients with HF. Trial registration: The PREVENT trial is registered at ClinicalTrials.gov, ID: NCT02040103 (registered on 3 November 2013, t2/show/study/NCT02040103 ) and Current controlled trials, ID: ISRCTN44653506 (registered on 30 October 2013).
Publisher: Massachusetts Medical Society
Date: 12-11-2009
Publisher: Springer Science and Business Media LLC
Date: 14-05-2018
DOI: 10.1007/S00134-018-5197-6
Abstract: To assess the effect of low dose corticosteroids on outcomes in adults with septic shock. We systematically reviewed randomised clinical trials (RCTs) comparing low-dose corticosteroids to placebo in adults with septic shock. Trial selection, data abstraction and risk of bias assessment were performed in duplicate. The primary outcome was short-term mortality. Secondary and tertiary outcomes included longer-term mortality, adverse events, quality of life, and duration of shock, mechanical ventilation and ICU stay. There were 22 RCTs, including 7297 participants, providing data on short-term mortality. In two low risk of bias trials, the relative risk (RR) of short-term mortality with corticosteroid versus placebo was 0.98 [95% confidence interval (CI) 0.89-1.08, p = 0.71]. Sensitivity analysis including all trials was similar (RR 0.96 95% CI 0.91-1.02, p = 0.21) as was analysis of longer-term mortality (RR 0.96 95% CI 0.90-1.02, p = 0.18). In low risk of bias trials, the risk of experiencing any adverse event was higher with corticosteroids however, there was substantial heterogeneity (RR 1.66 95% CI 1.03-2.70, p = 0.04, I In adults with septic shock treated with low dose corticosteroids, short- and longer-term mortality are unaffected, adverse events increase, but duration of shock, mechanical ventilation and ICU stay are reduced. PROSPERO registration no. CRD42017084037.
Publisher: Springer Science and Business Media LLC
Date: 16-07-2020
Publisher: Springer Science and Business Media LLC
Date: 07-11-2008
Publisher: Elsevier BV
Date: 09-2021
DOI: 10.51893/2021.3.OA4
Abstract: BACKGROUND: The β-Lactam Infusion Group (BLING) III study is a prospective, multicentre, open, phase 3 randomised controlled trial comparing continuous infusion with intermittent infusion of β-lactam antibiotics in 7000 critically ill patients with sepsis. OBJECTIVE: To describe a statistical analysis plan for the BLING III study. METHODS: The statistical analysis plan was designed by the trial statistician and chief investigators and approved by the BLING III management committee before the completion of data collection. Statistical analyses for primary, secondary and tertiary outcomes and planned subgroup analyses are described in detail. Interim analysis by the Data Safety and Monitoring Committee (DSMC) has been conducted in accordance with a pre-specified DSMC charter. RESULTS AND CONCLUSIONS: The statistical analysis plan for the BLING III study is published before completion of data collection and unblinding to minimise analysis bias and facilitate public access and transparent analysis and reporting of study findings. TRIAL REGISTRATION: ClinicalTrials.gov Registry NCT03212990.
Publisher: Springer Science and Business Media LLC
Date: 18-08-2020
Publisher: BMJ
Date: 12-2020
DOI: 10.1136/BMJOPEN-2020-040931
Abstract: The benefits and risks of low-dose hydrocortisone in patients with septic shock have been investigated in numerous randomised controlled trials and trial-level meta-analyses. Yet, the routine use of this treatment remains controversial. To overcome the limitations of previous meta-analyses inherent to the use of aggregate data, we will perform an in idual patient data meta-analysis (IPDMA) on the effect of hydrocortisone with or without fludrocortisone compared with placebo or usual care on 90-day mortality and other outcomes in patients with septic shock. To assess the benefits and risks of hydrocortisone, with or without fludrocortisone for adults with septic shock, we will search major electronic databases from inception to September 2020 (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and Latin American Caribbean Health Sciences Literature), complimented by a search for unpublished trials. The primary analysis will compare hydrocortisone with or without fludrocortisone to placebo or no treatment in adult patients with septic shock. Secondary analyses will compare hydrocortisone to placebo (or usual care), hydrocortisone plus fludrocortisone to placebo (or usual care), and hydrocortisone versus hydrocortisone plus fludrocortisone. The primary outcome will be all cause mortality at 90 days. We will conduct both one-stage IPDMA using mixed-effect models and machine learning with targeted maximum likelihood analyses. We will assess the risk of bias related to unshared data and related to the quality of in idual trial. This IPDMA will use existing data from completed randomised clinical trials and will comply with the ethical and regulatory requirements regarding data sharing for each of the component trials. The findings of this study will be submitted for publication in a peer-review journal with straightforward policy for open access. CRD42017062198.
Publisher: Springer Science and Business Media LLC
Date: 10-02-2011
DOI: 10.1007/S00134-010-2117-9
Abstract: The intravenous fluid 6% hydroxyethyl starch (130/0.4) (6% HES 130/0.4) is used widely for resuscitation but there is limited information on its efficacy and safety. A large-scale multi-centre randomised controlled trial (CHEST) in critically ill patients is currently underway comparing fluid resuscitation with 6% HES 130/0.4 to 0.9% sodium chloride on 90-day mortality and other clinically relevant outcomes including renal injury. This report describes the study protocol. CHEST will recruit 7,000 patients to concealed, random, parallel assignment of either 6% HES 130/0.4 or 0.9% sodium chloride for all fluid resuscitation needs whilst in the intensive care unit (ICU). The primary outcome will be all-cause mortality at 90 days post-randomisation. Secondary outcomes will include incident renal injury, other organ failures, ICU and hospital mortality, length of ICU stay, quality of life at 6 months, health economic analyses and in patients with traumatic brain injury, functional outcome. Subgroup analyses will be conducted in four predefined subgroups. All analyses will be conducted on an intention-to-treat basis. The study run-in phase has been completed and the main trial commenced in April 2010. CHEST should generate results that will inform and influence prescribing of this commonly used resuscitation fluid.
Publisher: Springer Science and Business Media LLC
Date: 11-12-2017
Publisher: Springer Science and Business Media LLC
Date: 03-02-2015
Publisher: Massachusetts Medical Society
Date: 10-01-2008
DOI: 10.1056/NEJME0708098
Publisher: SAGE Publications
Date: 03-2010
DOI: 10.1177/0310057X1003800207
Abstract: Over the last ten years more reliable information regarding the risks and benefits of the use of albumin for fluid resuscitation has emerged. To determine what influence this has had on clinical practice, we sought to document albumin use (from mass of albumin supplied to hospitals) in 16 industrialised countries between 1995 and 2006. Data on national albumin and synthetic colloid use was sought from independent intensive care researchers and albumin issuers. The mass of albumin supplied per 10,000 persons on an annual basis by country and aggregated across the study countries was calculated. Volumes of synthetic colloid supplied per 10,000 persons were calculated. Data were obtained for 15 countries. Albumin use varied significantly between countries and throughout the observation period. Overall, aggregate albumin use decreased from a peak of 2.54 kg per 10,000 persons in 1995 to 1.40 kg per 10,000 persons in 1999 use has remained relatively constant since. Data on supply of synthetic colloids was available in only three countries and varied from 11.7 litres per 10,000 persons in Canada in 1995, to 231.8 litres per 10,000 persons in Denmark in 2004. Between 1995 and 1999 albumin use decreased and has been materially constant since where data were available, use of synthetic colloids increased. Whether these practice changes have resulted in a net health gain or in harm requires further research.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 07-2017
DOI: 10.1097/CCM.0000000000002461
Abstract: A decreased frequency of upper gastrointestinal bleeding and a possible association of proton pump inhibitor use with Clostridium difficile and ventilator-associated pneumonia have raised concerns recently. The Reevaluating the Inhibition of Stress Erosions Pilot Trial determined the feasibility of undertaking a larger trial investigating the efficacy and safety of withholding proton pump inhibitors in critically ill patients. In 10 ICUs, we randomized adult ICU patients anticipated to be mechanically ventilated for greater than or equal to 48 hours to receive 40 mg of IV pantoprazole daily or placebo. We excluded patients who had acute or recent gastrointestinal bleed, used dual antiplatelet agents, had a medical condition requiring proton pump inhibitor treatment, or had already received more than one dose of acid suppression daily. Patients, families, clinicians, and research staff were blinded. We conducted a systematic review and meta-analysis of similar trials. Ninety-one patients (49 pantoprazole and 42 placebo) from 10 centers in Canada, Saudi Arabia, and Australia were enrolled. All feasibility goals were met: 1) recruitment rate was 2.6 patients per month 2) consent rate was 77.8% and 3) protocol adherence was 97.7%. Upper gastrointestinal bleeding developed in 6.1% of patients in the pantoprazole group and 4.8% in the placebo group ( p = 1.0). Ventilator-associated pneumonia developed in 20.4% of patients in the pantoprazole group and 14.3% in the placebo group ( p = 0.58). C. difficile was identified in 4.1% pantoprazole patients and in 2.4% placebo patients ( p = 1.0). We meta-analyzed five trials (604 patients) of proton pump inhibitors versus placebo there was no statistically significant difference in the risk of upper gastrointestinal bleeding, infections, or mortality. Our results support the feasibility of a larger trial to evaluate the safety of withholding stress ulcer prophylaxis. Although the results are imprecise, there was no alarming increase in the risk of upper gastrointestinal bleeding the effect of proton pump inhibitors on ventilator-associated pneumonia and C. difficile remain unclear.
Publisher: CMA Joule Inc.
Date: 22-04-2008
DOI: 10.1503/CMAJ.071366
Publisher: Elsevier BV
Date: 09-2023
Publisher: BMJ
Date: 15-06-1996
DOI: 10.1136/BMJ.312.7045.1538C
Abstract: Eating disorders and disturbed body image have been reported in in iduals with cystic fibrosis (CF) and may contribute to poor weight gain, reduced lung function and increased mortality. CF in iduals often look and feel different from their peers and bear the additional burden of body-altering side effects of treatment. As a result, the impact of disorders such as binge eating, anorexia nervosa, and bulimia nervosa may adversely affect the social, emotional, and physical development of those with CF. Multiple risk factors may contribute to the development of an eating disorder in CF. Growth failure is affected by the physical impairments of CF, including pancreatic insufficiency, high energy demands, respiratory infections, and delayed and stunted growth and puberty. Psychological factors, such as CF associated depression and anxiety, intense focus on BMI, lack of control in a chronic disease, and preoccupation with morbidity and mortality, likely further contribute. Exercise inefficiency, secondary to poor lung function, low BMI and pulmonary exacerbations, and the potential for medication manipulation are also additional risk factors. The intense scrutiny around BMI may lead to a poor relationship with food, including disordered eating habits, abnormal mealtime behaviors, and stressful caregiver-patient interactions regarding meals. This further contributes to a discrepancy between ideal CF nutritional standards and the reality of the challenges of appropriate daily energy intake for an in idual with CF. It is imperative that CF providers are equipped to identify potential eating disorders and disturbed body image in their CF patients. Improved screening and monitoring practices should be developed and implemented, with multidisciplinary support from all CF care team members, including dietitians, mental health professionals, and social workers, to best support holistic care and optimize outcomes. Increased attention to these concerns may help reduce CF related morbidity and mortality.
Publisher: American Thoracic Society
Date: 10-2022
Publisher: Springer Science and Business Media LLC
Date: 12-1996
DOI: 10.1007/BF01709564
Abstract: Coronavirus disease 2019 (COVID-19) infection is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This infection usually presents with upper respiratory symptoms however, it can also present with a wide variety of other multisystem and neurological symptoms, including seizures. There are several proposed mechanisms by which COVID-19 can cause systemic signs of infections, including neurological complications and seizures. This case report describes a pediatric patient without a previously documented history of epilepsy who was admitted for new-onset focal seizures with impaired consciousness. No other cause and triggers of seizures were found, and the child was tested positive for COVID-19 infection. The patient had six electroclinical seizures during EEG. Video EEG findings showed atypical features of onset of intermittent rhythmic delta activity (IRDA) slowing over the left hemisphere with evolution/generalization of rhythmic delta/theta activity and without clear typical generalized epileptiform discharges. These EEG findings correlated with a clinical change of behavior arrest, staring, and yawning. Similar spells were reported multiple times a day prior to the admission, and past EEG was normal. A review of current literature on COVID-19 and neurological manifestations in children, including new seizures and prior diagnosis of epilepsy, is also provided in this case report. The clinical experience in children with newly diagnosed or chronic epilepsy suggests that exacerbation of seizures, especially from systemic effects such as those caused by severe COVID-19 infection, will be a major concern.
Publisher: GN1 Genesis Network
Date: 2015
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2015
DOI: 10.1161/STROKEAHA.115.010575
Abstract: Delayed cerebral ischemia (DCI) is an important cause of poor outcome after aneurysmal subarachnoid hemorrhage (SAH). Trials of magnesium treatment starting days after symptom onset found no effect on poor outcome or DCI in SAH. Earlier installment of treatment might be more effective, but in idual trials had not enough power for such a subanalysis. We performed an in idual patient data meta-analysis to study whether magnesium is effective when given within different time frames within 24 hours after the SAH. Patients were ided into categories according to the delay between symptom onset and start of the study medication: , 6 to 12, 12 to 24, and hours. We calculated adjusted risk ratios with corresponding 95% confidence intervals for magnesium versus placebo treatment for poor outcome and DCI. We included 5 trials totaling 1981 patients 83 patients started treatment hours. For poor outcome, the adjusted risk ratios of magnesium treatment for start hours were 1.44 (95% confidence interval, 0.83–2.51) for 6 to 12 hours 1.03 (0.65–1.63), for 12 to 24 hours 0.84 (0.65–1.09), and for hours 1.06 (0.87–1.31), and for DCI, hours 1.76 (0.68–4.58), for 6 to 12 hours 2.09 (0.99–4.39), for 12 to 24 hours 0.80 (0.56–1.16), and for hours 1.08 (0.88–1.32). This meta-analysis suggests no beneficial effect of magnesium treatment on poor outcome or DCI when started early after SAH onset. Although the number of patients was small and a beneficial effect cannot be definitively excluded, we found no justification for a new trial with early magnesium treatment after SAH.
Publisher: Cold Spring Harbor Laboratory
Date: 13-04-2021
DOI: 10.1101/2021.04.08.21254902
Abstract: To investigate critical care resourcing and the clinical management of sepsis in lower-middle income, upper-middle income and high income countries across the Asia Pacific region. Sepsis is a time-critical complex condition that requires evidence-based care delivered by appropriate levels of well trained, qualified and experienced staff supported by proactive organisational and quality processes, sophisticated technologies and reliable infrastructure. In 2017, the estimated sepsis incidence in the Asia Pacific region ranged from 120 to 200 per 100,000 population in Australia and New Zealand to 2500 to 3400 per 100,000 population in India. Currently, there is limited information on the organisational structures, human resources, clinical standards, laboratory support and the therapeutic options available in the Asia Pacific region to treat sepsis. Prospective electronic survey. Representatives of 59 hospitals from 15 countries responded. Provision of critical care and the management of sepsis varied considerably between lower-middle income, upper-middle income and high income countries. Specific differences include nurse to patient ratios and availability of allied health services. Conventional organ support modalities such as mechanical ventilation and non-invasive ventilation were commonly available. Even advanced life support like extracorporeal membrane oxygenation was available in at least 60% of surveyed ICUs. However, in contrast, essential monitoring devices including EtCO2 were not universally available. Lower-middle income countries had considerably lower provisions for isolation and surge capacity to support pandemic and disaster management, though basic personal protective equipment was widely available. A majority of ICUs used the Surviving Sepsis C aign guidelines or the adapted version for lower-middle income countries, though only 21% of ICUs in lower-middle income countries used the adapted version. While essential antimicrobials were accessible across most ICUs, availability of reserve antibiotics was limited. The disparities identified in this survey inform healthcare workers and health services, policy makers and governments on the priorities for action to improve the delivery of critical care and sepsis outcomes in this region.
Publisher: American Thoracic Society
Date: 09-2020
Publisher: AMPCo
Date: 09-2018
DOI: 10.5694/MJA18.00168
Abstract: To compare estimates of the incidence and mortality of sepsis and septic shock among patients in Australian intensive care units (ICUs) according to clinical diagnoses or binational intensive care database (ANZICS CORE) methodology. Prospective inception cohort study (3-month inception period, 1 October - 31 December 2016, with 60-day follow-up) daily screening of all patients in a tertiary hospital 60-bed multidisciplinary ICU. Diagnoses of sepsis and septic shock according to clinical criteria and database criteria in-hospital mortality (censored at 60 days). Of 864 patients admitted to the ICU, 146 (16.9%) were diagnosed with sepsis by clinical criteria and 98 (11%) according to the database definition (P < 0.001) the sensitivity of the database criteria for sepsis was 52%, the specificity 97%. Forty-nine patients (5.7%) were diagnosed with septic shock by clinical criteria and 83 patients (9.6%) with the database definition (P < 0.001) the sensitivity of the database criteria for septic shock was 65%, the specificity 94%. In-hospital mortality of patients diagnosed with sepsis was greater in the clinical diagnosis group (39/146, 27%) than in the database group (17/98, 17% P = 0.12) for septic shock, mortality was significantly higher in the database group (18/49, 37%) than in the clinical diagnosis group (13/83, 16% P = 0.006). When compared with the reference standard - prospective clinical diagnosis - ANZICS CORE database criteria significantly underestimate the incidence of sepsis and overestimate the incidence of septic shock, and also result in lower estimated hospital mortality rates for each condition.
Publisher: Springer Science and Business Media LLC
Date: 1999
DOI: 10.1186/CC344
Abstract: BACKGROUND: For logistical reasons sedation studies are often carried out in elective surgical patients and the results extrapolated to the general intensive care unit (ICU) population. We question the validity of this approach. We compared the two sedation regimens used in our general ICU in a trial structured to mimic clinical practice as closely as possible. RESULTS: Forty patients were randomised to intermittent diazepam or continuous midazolam and sedation monitored with hourly sedation scores 31 patients completed the study. Scores indicating undersedation were more common with diazepam (P <0.01) overall adequate sedation midazolam 64.7%, diazepam 35.7% (P =0.21). No patient exhibited inappropriately prolonged sedation. Cost was: midazolam AUS$1.98/h diazepam AUS$0.06/h. CONCLUSION: Both regimens produced rapid onset of acceptable sedation but undersedation appeared more common with the cheaper diazepam regimen. At least 140 patients should be studied to provide evidence applicable to the general ICU population. Used alone, a sedation score may be an inappropriate outcome measure for a sedation trial.
Publisher: Springer Science and Business Media LLC
Date: 2014
DOI: 10.1186/CC13921
Publisher: Elsevier BV
Date: 03-2019
Publisher: Elsevier BV
Date: 10-2022
DOI: 10.1016/J.JCRC.2022.154079
Abstract: To compare the effect of conservative vs. liberal oxygen therapy in mechanically ventilated adults in the intensive care unit (ICU) with non-hypoxic ischemic encephalopathy (HIE) acute brain pathologies. Post-hoc analysis of data from 217 patients with non-HIE acute brain pathologies included in the ICU Randomized Trial Comparing Two Approaches to OXygen therapy (ICU-ROX). Patients allocated to conservative oxygen spent less time with oxygen saturation ≥ 97% (50.5 [interquartile range (IQR), 18.5-119] vs. 82 h [IQR, 38-164], absolute difference, -31.5 h 95%CI, -59.6 to -3.4). At 180 days, 38 of 110 conservative oxygen patients (34.5%) and 28 of 104 liberal oxygen patients (26.9%) had died (absolute difference, 7.6 percentage points 95%CI, -4.7 to 19.9 percentage points P = 0.23 interaction P = 0.02 for non-HIE acute brain pathologies vs. HIE interaction P = 0.53 for non-HIE acute brain pathologies vs. non-neurological conditions). In this post-hoc analysis, patients admitted to the ICU with non-HIE acute brain pathologies treated with conservative oxygen therapy did not have significantly lower mortality than those treated with liberal oxygen. A trial with adequate statistical power is needed to determine whether our day 180 mortality point estimate of treatment effect favoring liberal oxygen therapy indicates a true effect.
Publisher: Elsevier BV
Date: 06-2014
DOI: 10.1016/J.JCRC.2014.02.004
Abstract: Thrombocytopenia occurs in 20% to 45% of critically ill medical-surgical patients. The 4Ts heparin-induced thrombocytopenia (HIT) score (with 4 domains: Thrombocytopenia, Timing of thrombocytopenia, Thrombosis and oTher reason[s] for thrombocytopenia) might reliably identify patients at low risk for HIT. Interobserver agreement on 4Ts scoring is uncertain in this setting. To evaluate whether a published clinical prediction rule (the "4Ts score") reliably rules out HIT in "low-risk" intensive care unit (ICU) patients as assessed by research coordinators (who prospectively scored) and 2 adjudicators (who scored retrospectively) during an international heparin thromboprophylaxis trial (PROTECT, NCT00182143). Of 3746 medical-surgical ICU patients in PROTECT, 794 met the enrollment criteria for this HIT substudy. Enrollment was predicated on one of the following occurring in ICU: platelets less than 50×10(9)/L, platelets decreased to 50% of ICU admission value (if admission value<100×10(9)/L), any venous thrombosis, or if HIT was otherwise clinically suspected. Independently, 4Ts scores were completed in real time by research coordinators blinded to study drug and laboratory HIT results, and retrospectively by 2 adjudicators blinded to study drug, laboratory HIT results, and research coordinators' scores the adjudicators arrived at consensus in all cases. Of the 763 patients, 474 had a central or local laboratory HIT test performed and had 4Ts scoring by adjudicators 432 were scored by trained research coordinators. Heparin-induced thrombocytopenia was defined by a centrally performed positive serotonin release assay (SRA). Of the 474 patients with central adjudication, 407 (85.9%) had a 4Ts score of 3 or lower, conferring a low pretest probability (PTP) of HIT of these, 6 (1.5% [95% confidence interval, 0.7%-3.2%) had a positive SRA. Fifty-nine (12.4%) had a moderate PTP (4Ts score of 4-5) of these, 4 (6.8%) had a positive SRA. Eight patients had a high PTP (4Ts score of ≥6) of these, 1 (12.5%) had a positive SRA. Raw agreement between research coordinators and central adjudication on each domain of the 4Ts score and low, intermediate, and high PTP was good. However, chance-corrected agreement was variable between adjudicators (weighted κ values of 0.31-0.93) and between the adjudicator consensus and research coordinators (weighted κ values of 0.13 and 0.78). Post hoc review of the 6 SRA-positive cases with an adjudicated low PTP demonstrated that their scores would have been increased if the adjudicators had had additional information on heparin exposure prior to ICU admission. In general, the fourth domain of 4Ts (oTher causes of thrombocytopenia) generated the most disagreement. Real-time 4Ts scoring by research coordinators at the time of testing for HIT was not consistent with 4Ts scores obtained by central adjudicators. The results of this comprehensive HIT testing highlight the need for further research to improve the assessment of PTP scoring of HIT for critically ill patients.
Publisher: Springer Science and Business Media LLC
Date: 06-2004
Publisher: BMJ
Date: 16-11-2022
Abstract: To determine whether disrupting the renin angiotensin system with angiotensin receptor blockers will improve clinical outcomes in people with covid-19. CLARITY was a pragmatic, adaptive, multicentre, phase 3, randomised controlled trial. 17 hospital sites in India and Australia. Participants were at least 18 years old, previously untreated with angiotensin receptor blockers, with a laboratory confirmed diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection who had been admitted to hospital for management of covid-19. Oral angiotensin receptor blockers (telmisartan in India) or placebo (1:1) for 28 days. The primary endpoint was covid-19 disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at day 14. Secondary outcomes were WHO scale scores at day 28, mortality, intensive care unit admission, and respiratory failure. Analyses were evaluated on an ordinal scale in the intention-to-treat population. Between 3 May 2020 and 13 November 2021, 2930 people were screened for eligibility, with 393 randomly assigned to angiotensin receptor blockers (of which 388 (98.7%) to telmisartan 40 mg/day) and 394 to the control group. 787 participants were randomised: 778 (98.9%) from India and nine (1.1%) from Australia. The median WHO scale score at day 14 was 1 (interquartile range 1-1) in 384 participants assigned angiotensin receptor blockers and 1 (1-1) in 382 participants assigned placebo (adjusted odds ratio 1.51 (95% credible interval 1.02 to 2.23), probability of an odds ratio of (Pr(OR )=0.98). WHO scale scores at day 28 showed little evidence of difference between groups (1.02 (0.55 to 1.87), Pr(OR )=0.53). The trial was stopped when a prespecified futility rule was met. In patients admitted to hospital for covid-19, mostly with mild disease, not requiring oxygen, no evidence of benefit, based on disease severity score, was found for treatment with angiotensin receptor blockers, using predominantly 40 mg/day of telmisartan. ClinicalTrials.gov NCT04394117 .
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2010
Publisher: American Medical Association (AMA)
Date: 28-03-2023
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2015
Publisher: Massachusetts Medical Society
Date: 31-05-2012
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2015
Publisher: SAGE Publications
Date: 2022
DOI: 10.1177/17455065221076738
Abstract: The COVID-19 pandemic provides a contemporaneous illustration of the need to consider sex and gender in research. Using surveillance, treatment and vaccine research ex les, in this commentary review, we highlight opportunities for innovation in sex- and gender-sensitive and transformative health and medical research.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 20-01-2023
DOI: 10.1097/CCM.0000000000005721
Abstract: All-cause mortality is a common measure of treatment effect in ICU-based randomized clinical trials (RCTs). We sought to understand the performance characteristics of a mortality endpoint by evaluating its temporal course, responsiveness to differential treatment effects, and impact when used as an outcome measure in trials of acute illness. We searched OVID Medline for RCTs published from 1990 to 2018. We reviewed RCTs that had randomized greater than or equal to 100 patients, were published in one of five high-impact general medical or eight critical care journals, and reported mortality at two or more distinct time points. We excluded trials recruiting pediatric or neonatal patients and cluster RCTs. Mortality by randomization group was recorded from the article or estimated from survival curves. Trial impact was assessed by inclusion of results in clinical practice guidelines. From 2,592 potentially eligible trials, we included 343 RCTs (228,784 adult patients). While one third of all deaths by 180 days had occurred by day 7, the risk difference between study arms continued to increase until day 60 ( p = 0.01) and possibly day 90 ( p = 0.07) and remained stable thereafter. The number of deaths at ICU discharge approximated those at 28–30 days (95% [interquartile range [IQR], 86–106%]), and deaths at hospital discharge approximated those at 60 days (99% [IQR, 94–104%]). Only 13 of 43 interventions (30.2%) showing a mortality benefit have been adopted into widespread clinical practice. Our findings provide a conceptual framework for choosing a time horizon and interpreting mortality outcome in trials of acute illness. Differential mortality effects persist for 60 to 90 days following recruitment. Location-based measures approximate time-based measures for trials conducted outside the United States. The documentation of a mortality reduction has had a modest impact on practice.
Publisher: Springer Science and Business Media LLC
Date: 09-01-2009
Publisher: Elsevier BV
Date: 04-2018
Publisher: Wiley
Date: 05-1993
Publisher: Springer Science and Business Media LLC
Date: 12-2014
Publisher: BMJ
Date: 28-05-1994
Publisher: Elsevier BV
Date: 04-1991
DOI: 10.1093/BJA/66.4.509
Abstract: A patient with a permanent pacemaker presented for repair of a strangulated hernia. During induction of anaesthesia, the pacemaker generator stopped discharging, thus causing cardiac arrest. The likely cause of the generator failure was inhibition by suxamethonium-induced muscle fasciculations. Following defibrillation, and increase in stimulation threshold necessitated urgent insertion of a transvenous pacing system. It is suggested that, when suxamethonium is to be used in a patient with a permanent pacemaker, consideration should be given to reprogramming the pacemaker to asynchronous mode before induction of anaesthesia. If a patient with a pacemaker requires defibrillation, an acute increase in stimulation threshold may result and cause loss of capture. Rapid insertion of a transvenous pacing system may be necessary.
Publisher: Springer Science and Business Media LLC
Date: 2011
DOI: 10.1186/CC10427
Publisher: Elsevier BV
Date: 2001
DOI: 10.1016/S0300-9572(00)00321-X
Abstract: In western countries, injuries remain the leading cause of death in young adults (Jennett B. Epidemiology of head injury. J Neurol Neurosurg Psychiatry 1996 60: 362-369). Worldwide, injuries are estimated to account for 15% of the burden of death and disability, and are projected to account for 20% in 2020 (Ad Hoc Committee on Health Research Relating to Future Intervention Options. Investing in Health Research and Development (Document TDR/Gen/96.1). Geneva: World Health Organisation, 1996). In developing countries road traffic injuries in particular are increasing in incidence and injuries are projected to be the third leading cause of death and disability worldwide by 2020 (Ad Hoc Committee on Health Research Relating to Future Intervention Options. Investing in Health Research and Development (Document TDR/Gen/96.1). Geneva: World Health Organisation, 1996). Head injury accounts for up to half of all deaths from trauma (Kraus J. Epidemiology of head injury. In: Cooper PR, Ed. Head Injury, 3rd ed. Baltimore, MD: William Wilkins, 1993), and in addition to causing death often causes severe and long-lasting functional impairment in survivors.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2012
Publisher: Elsevier BV
Date: 09-2019
DOI: 10.1016/J.AUCC.2018.09.001
Abstract: Approximately 9000 patients with type-2 diabetes mellitus (T2DM) are admitted to an intensive care unit (ICU) in Australia and New Zealand annually. For these patients, recent exploratory data suggest that targeting a more liberal blood glucose range during ICU admission may be safe and potentially beneficial. However, the current approach to blood glucose management of patients with T2DM in Australia and New Zealand ICUs is not well described, and there is uncertainty about clinician equipoise for trials of liberal glycaemic control in these patients. The aim is to describe self-reported blood glucose management in patients with T2DM by intensivists working in Australian and New Zealand ICUs and to establish whether equipoise exists for a trial of liberal versus standard glycaemic control in such patients. An online questionnaire of Australia and New Zealand intensivists conducted in July-September 2016. Seventy-one intensivists responded. Forty-five (63%) used a basic nomogram to titrate insulin. Sixty-six (93%) reported that insulin was commenced at blood glucose concentrations >10 mmol/L and titrated to achieve a blood glucose concentration between 6.0 and 10.0 mmol/L. A majority of respondents (75%) indicated that there was insufficient evidence to define optimal blood glucose targets in patients with T2DM, and 59 (83%) were prepared to enrol such patients in a clinical trial to evaluate a more liberal approach. A majority of respondents were uncertain about the optimal blood glucose target range for patients with T2DM and would enrol such patients in a comparative trial of conventional versus liberal blood glucose control.
Publisher: Elsevier BV
Date: 02-2019
DOI: 10.1016/J.JCRC.2018.10.017
Abstract: To investigate the relationship between sex and mortality and whether menopause or the intensity of renal replacement therapy (RRT) modify this relationship in patients with severe septic acute kidney injury (AKI). Post-hoc analysis of patients with sepsis included in the Randomized Evaluation of Normal versus Augmented Level renal replacement therapy (RENAL) trial. Of 724 patients, 458 (63.3%) were male and 266 (36.7%) were female. The mean delivered effluent flow rate was 25.6 ± 7.4 ml/kg/h (80 ± 15% of prescribed dose) in males and 27.4 ± 7.6 ml/kg/h (83 ± 15% of prescribed dose) in females (p = .01). A total of 237 (51.7%) males and 118 (44.5%) females died within 90 days of randomization (p = .06). The adjusted hazard ratio (HR) for 90-day mortality was significantly decreased in females as compared with males (HR 0.74, 95% CI 0.57 to 0.96, p = .02). The relationship between sex and mortality was not significantly altered by menopausal status (adjusted P value for interaction 0.99) or by RRT intensity allocation (adjusted P value for interaction 0.27). In a cohort of patients with sepsis and severe AKI, female sex was associated with improved survival. The relationship between sex and survival was not altered by menopausal status or RRT intensity.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 03-2007
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2016
Publisher: SAGE Publications
Date: 11-08-2023
DOI: 10.1177/08850666231192371
Abstract: To provide an overview of various sepsis International Classification of Diseases (ICD) coding methods and their diagnostic accuracy. We undertook a systematic scoping review between 1991 and 2020 (search terms: sepsis, coding, and epidemiology) to include studies reporting the accuracy of a sepsis ICD coding method. Studies were grouped by ICD coding method, number of diagnostic accuracy parameters, ICD version, reference standard, design, country, setting, type of dataset and sepsis definition. ICD coding methods were categorised as explicit or implicit, with the explicit methods further ided into wide and narrow groups. Descriptive statistics were used to present data. We analysed 17 studies, of which 16 (94.1%) used retrospective medical chart review as the reference standard for clinical sepsis, and eight (47.1%) used hospital administrative data to identify sepsis. There were 53 assessments of various ICD coding methods, with 32 (60.4%) of them being explicit and 21 (39.6%) implicit methods. The coding methods had a median sensitivity of % but a median specificity of %. However, a wide variation was noted in the diagnostic accuracy parameters of all ICD coding methods. Most of the studies showed high methodological quality. None of the current ICD coding methods is optimal for identifying sepsis.
Publisher: Springer Science and Business Media LLC
Date: 23-08-2016
Publisher: Springer Science and Business Media LLC
Date: 20-11-2019
Publisher: BMJ
Date: 02-11-2006
Publisher: Elsevier BV
Date: 02-2015
Publisher: Massachusetts Medical Society
Date: 10-11-2022
Publisher: Elsevier BV
Date: 08-1998
Publisher: Massachusetts Medical Society
Date: 24-11-2016
DOI: 10.1056/NEJMC1610367
Publisher: AMPCo
Date: 09-2004
DOI: 10.5694/J.1326-5377.2004.TB06258.X
Abstract: High-quality primary evidence from an Australian and New Zealand study provides a definitive answer.
Publisher: Elsevier BV
Date: 10-2016
Publisher: Springer Science and Business Media LLC
Date: 30-08-2023
DOI: 10.1186/S13063-023-07589-2
Abstract: Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use in the intensive care unit (ICU), observational data suggest that PPIs may be associated with adverse outcomes in patients with COVID-19 infection. This preplanned study is nested within a large randomized trial evaluating pantoprazole versus placebo in invasively ventilated patients. The 3 objectives are as follows: (1) to describe the characteristics of patients with COVID-19 in terms of demographics, biomarkers, venous thromboembolism, tracheostomy incidence and timing, and other clinical outcomes (2) to evaluate the impact of COVID-19 infection on clinically important GI bleeding, 90-day mortality, and other outcomes compared to a propensity-matched non-infected cohort and (3) to explore whether pantoprazole has a differential treatment effect on clinically important GI bleeding, 90-day mortality, and other outcomes in patients with and without COVID-19 infection. The ongoing trial Re-EValuating the Inhibition of Stress Erosions (REVISE) compares pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important GI bleeding and the primary safety outcome of 90-day mortality. The protocol described in this report is for a substudy focused on patients with COVID-19 infection that was not in the original pre-pandemic trial protocol. We developed a one-page case report form to characterize these patients including data related to biomarkers, venous thromboembolism, COVID-19 therapies, tracheostomy incidence and timing, duration of mechanical ventilation, and ICU and hospital stay. Our analysis will describe the trajectory of patients with COVID-19 infection, a propensity-matched analysis of infected and non-infected patients, and an extended subgroup analysis comparing the effect of PPI among patients with and without COVID-19 infection. Prophylactic acid suppression in invasively ventilated critically ill patients with COVID-19 infection has unknown consequences. The results of these investigations will inform practice, guidelines, and future research. REVISE Trial [NCT03374800 December 15, 2017], COVID-19 Cohort Study [NCT05715567 February 8, 2023].
Publisher: Elsevier BV
Date: 08-2017
Publisher: American Thoracic Society
Date: 03-2007
Publisher: American Medical Association (AMA)
Date: 12-03-2014
Publisher: Massachusetts Medical Society
Date: 18-09-2003
DOI: 10.1056/NEJMOA030083
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC13023
Publisher: Elsevier BV
Date: 09-2008
Publisher: Mary Ann Liebert Inc
Date: 06-2022
Abstract: High quality evidence shows decompressive craniectomy (DC) following traumatic brain injury (TBI) may improve survival but increase the number of severely disabled survivors. Contemporary international practice is unknown. We sought to describe international use of DC, and the alignment with evidence and clinical practice guidelines, by analyzing the harmonized Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) and Australia-Europe NeuroTrauma Effectiveness Research in Traumatic Brain Injury (OzENTER-TBI) core study datasets, which include patients admitted to intensive care units (ICUs) in Europe, the United Kingdom, and Australia between 2015 and 2017. Outcomes of interest were treatment with DC relative to clinical trial evidence and the Brain Trauma Foundation guidelines. Of 2336 people admitted to ICUs following TBI, DC was performed in 320 (13.7%): in 64/1422 (4.5%) patients with diffuse TBI and 195/640 (30.5%) patients with traumatic mass lesions. Secondary DC (for treatment of intracranial hypertension) was used infrequently in patients who met enrollment criteria of the two randomized clinical trials informing the guidelines-specifically, in 11/124 (8.9%) of those matching Decompressive Craniectomy in Diffuse Traumatic Brain Injury trial (DECRA) enrollment, and in 30/224 (13.4%) of those matching Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure (RESCUEicp). Of patients who underwent DC, 258/320 (80.6%) were ineligible for either trial: 149/320 (46.6%) underwent primary DC, 62/320 (19.4%) were outside the trials' age criteria, and 126/320 (39.4%) did not develop intracranial hypertension refractory to non-operative therapies prior to DC. Secondary DC was used infrequently in patients in whom it had been shown to increase survival with severe disability, indicating alignment between contemporaneous evidence and practice. However, most patients who underwent DC were ineligible for the key trials whether they benefited from DC remains unknown.
Publisher: Elsevier BV
Date: 10-2023
Publisher: Massachusetts Medical Society
Date: 25-01-2022
Publisher: Elsevier BV
Date: 02-2023
Publisher: Springer Science and Business Media LLC
Date: 12-2009
Publisher: Springer Science and Business Media LLC
Date: 04-05-2010
Publisher: Elsevier BV
Date: 07-2000
Publisher: SAGE Publications
Date: 04-1999
DOI: 10.1177/0310057X9902700206
Abstract: This study investigated the incidence of and risk factors for central venous catheter (CVC) infection in intensive care. CVCs were prospectively studied in patients who had lines inserted in general or neurosurgical intensive care and were expected to have the line in situ for at least 72 hours. Catheters (n=119) were cultured for CVC-related infection (CRI colony forming units) and blood cultures done when indicated. CRI was identified in 32 (26.9%) catheters, CVC related bacteraemia in five cases (4.2%) and CVC related sepsis in none. After adjustment for duration of catheterization, independent predictors of CVC related infection were catheter insertion site, with jugular sites having the highest risk, and primary diagnosis, with neurosurgical patients at least risk.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2004
DOI: 10.1097/01.CCM.0000126402.51524.52
Abstract: Predicting outcomes for critically ill patients is an important aspect of discussions with families in the intensive care unit. Our objective was to evaluate clinical intensive care unit survival predictions and their consequences for mechanically ventilated patients. Prospective cohort study. Fifteen tertiary care centers. Consecutive mechanically ventilated patients > or = 18 yrs of age with expected intensive care unit stay > or = 72 hrs. We recorded baseline characteristics at intensive care unit admission. Daily we measured multiple organ dysfunction score (MODS), use of advanced life support, patient preferences for life support, and intensivist and bedside intensive care unit nurse estimated probability of intensive care unit survival. The 851 patients were aged 61.2 (+/- 17.6, mean + SD) yrs with an Acute Physiology and Chronic Health Evaluation (APACHE) II score of 21.7 (+/- 8.6). Three hundred and four patients (35.7%) died in the intensive care unit, and 341 (40.1%) were assessed by a physician at least once to have a < 10% intensive care unit survival probability. Independent predictors of intensive care unit mortality were baseline APACHE II score (hazard ratio, 1.16 95% confidence interval, 1.08-1.24, for a 5-point increase) and daily factors such as MODS (hazard ratio, 2.50 95% confidence interval, 2.06-3.04, for a 5-point increase), use of inotropes or vasopressors (hazard ratio, 2.14 95% confidence interval, 1.66-2.77), dialysis (hazard ratio, 0.51 95% confidence interval, 0.35-0.75), patient preference to limit life support (hazard ratio, 10.22 95% confidence interval, 7.38-14.16), and physician but not nurse prediction of < 10% survival. The impact of physician estimates of < 10% intensive care unit survival was greater for patients without vs. those with preferences to limit life support (p < .001) and for patients with less vs. more severe organ dysfunction (p < .001). Mechanical ventilation, inotropes or vasopressors, and dialysis were withdrawn more often when physicians predicted < 10% probability of intensive care unit survival (all ps < .001). Physician estimates of intensive care unit survival < 10% are associated with subsequent life support limitation and more powerfully predict intensive care unit mortality than illness severity, evolving or resolving organ dysfunction, and use of inotropes or vasopressors.
Publisher: Wiley
Date: 15-12-2005
DOI: 10.1111/J.1365-2044.2005.04381.X
Abstract: A 43-year-old man developed septic shock and acute lung injury after surgery to drain an ischiorectal abscess. In the intensive care unit he initially improved but developed severe hypoxaemia, right ventricular failure and pulmonary hypertension 90 min after receiving intravenous calcium gluconate and potassium phosphate, best explained by the formation of a calcium-phosphate precipitant that resulted in aggregate anaphylaxis. His rapid deterioration and lack of response to conventional therapies necessitated support with extracorporeal membrane oxygenation that was life saving. This adverse event has altered local practice regarding calcium and phosphate replacement and has implications for all intensive care units.
Publisher: Springer Science and Business Media LLC
Date: 2008
DOI: 10.1186/CC6849
Publisher: Massachusetts Medical Society
Date: 03-2018
Publisher: Elsevier BV
Date: 04-0012
DOI: 10.1016/J.JCRC.2005.09.002
Abstract: Internationally, there is practice variation concerning optimal thromboprophylaxis for patients in the intensive care unit (ICU). The current practice in Australia and New Zealand is unknown. We conducted a self-administered e-mail survey of 22 Australian and New Zealand ICUs expressing interest in participating in a proposed international randomized trial (PROphylaxis for ThromboEmbolism in Critical Care Trial). Our response rate was 95.4% (95% CI, 77%-100%). Of participating ICUs, 90.5% (95% CI, 70%-99%) used subcutaneous unfractionated heparin for routine thromboprophylaxis in ICU patients. Low-molecular-weight heparin was reserved for specific high-risk patients in many units. Routine thromboprophylaxis for ICU patients in Australia and New Zealand is similar to Canada but different to France. Optimal thromboprophylaxis for ICU patients is currently unclear in the absence of randomized trial data.
Publisher: Elsevier BV
Date: 03-2017
Publisher: SAGE Publications
Date: 10-2005
DOI: 10.1177/0310057X0503300506
Abstract: We assessed the impact of operator expertise on collection of the APACHE II score, the derived risk of death and standardized mortality ratio in 465 consecutive patients admitted to a multi-disciplinary tertiary hospital ICU. Research coordinators and junior clinical staff independently collected the APACHE II variables experts (senior clinical staff) rescored 20 % of the records. Agreement was moderate between junior clinical staff and research coordinators or senior clinical staff for most variables of the acute physiology score (weighted κ .6) agreement between research coordinators and senior clinical staff data collectors was good (weighted κ .75). The APACHE II score and its derived risk of death (ROD) were significantly lower using the junior clinical staff dataset compared to research coordinators and senior clinical staff (APACHE II score: 13.4±9.2 vs 16.8±8.5 vs 17.1±7.7, P .001 ROD: 14.7%±22.4% vs 21.6%±22.6% vs 20.8%±22.4%, P .01 respectively). The discriminative capacity was not altered by the lack of agreement (area under Receiver Operator Characteristic curve .8) but calibration of ROD from the junior clinical staff dataset was poor (Goodness-of-fit: P=0.001). The standardized mortality ratio (SMR) was higher with the junior clinical staff dataset (SMR: 1.22, 95% CI: 0.96-1.52 vs 0.87, 95% CI: 0.70-1.06 vs 0.76, 95% CI: 0.40-1.3 calculated from junior clinical staff, research coordinators and senior clinical staff data-sets respectively). We conclude that the expertise of data collectors significantly influences the APACHE II score, the derived risk of death and the standardized mortality ratio. Given the importance of such scores, ICUs should be provided with sufficient resources to train and employ dedicated data collectors.
Publisher: Elsevier BV
Date: 06-2021
DOI: 10.51893/2021.2.OA5
Abstract: Background: It is unclear whether the use of selective decontamination of the digestive tract (SDD) improves outcomes in ventilated patients in intensive care units (ICUs) and whether SDD is associated with the development of antibiotic resistance. Objective: To describe the study protocol and statistical analysis plan for the Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients (SuDDICU) trial. Design, setting, participants and intervention: SuDDICU is an international, crossover, cluster randomised controlled trial of mechanically ventilated patients in ICUs using two 12-month trial periods. For each period, participating ICUs will implement SDD plus standard care or standard care alone. The SuDDICU drug intervention is an oral paste and gastric suspension of three antibiotics combined with a 4-day course of intravenous antibiotics. Observational ecological assessments will be conducted during five surveillance periods. The trial will be conducted in 19 ICUs in Australia and ten ICUs in Canada and the United Kingdom, and will recruit 15 000–17 000 patients. Recruitment commenced in Australia in 2017. Main outcome measures: The primary outcome is all-cause hospital mortality. Secondary outcomes include: duration of ventilation, ICU stay and hospital stay incidence of new antibiotic-resistant organisms during the index ICU admission changes in antibiotic-resistant organism rates incidence of new Clostridioides difficile infections and total use of antibiotics. Results and conclusions: SuDDICU will determine whether the use of SDD plus standard care is associated with a reduction in hospital mortality in ventilated ICU patients compared with standard care alone. It will also quantify the impact of the use of SDD on the development of antibiotic resistance. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12615000411549) and ClinicalTrials.gov (NCT02389036).
Publisher: Elsevier BV
Date: 10-2018
Publisher: SAGE Publications
Date: 08-2001
DOI: 10.1177/0310057X0102900403
Abstract: Serial serum thiopentone concentrations were measured during and following completion of an intravenous infusion of thiopentone in 20 patients with neurosurgical emergencies. The concentration data from a further 55 patients who had had some such measurements were reviewed retrospectively. The patients received an infusion for longer than 24 hours at a rate adjusted to maintain EEG burst suppression. The data were interpreted in terms of thiopentone pharmacokinetics and used to produce statistical models relating to clinical outcomes. In these patients, the one-month mortality rate following commencement of thiopentone treatment was 20% the mean durations of pupillary and motor unresponsiveness following cessation of an infusion were 22 and 91 hours, respectively. Predictors of a prolonged duration of motor unresponsiveness included a prolonged duration of pupillary unresponsiveness, a low thiopentone clearance and a high maximum serum concentration of thiopentone. From pooled logistic regression, median effective serum thiopentone concentrations (EC 50 ) were found to be 50 mg.l –1 for recovery of pupillary responsiveness and 12 mg.l –1 for the recovery of motor responsiveness. Because prolonged high-dose thiopentone leads to prolonged residual serum concentrations, it is difficult to distinguish the residual pharmacological effects of thiopentone from the clinical condition. This study suggests that, based on EC 50 values for responses, monitoring of post-infusion serum thiopentone concentrations may help determine whether a patient's clinical state is due to residual thiopentone pharmacological effects.
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC13030
Publisher: Elsevier BV
Date: 2020
Publisher: Springer Science and Business Media LLC
Date: 16-06-2021
Publisher: Elsevier BV
Date: 05-2015
DOI: 10.1093/BJA/AEV077
Publisher: CMA Joule Inc.
Date: 24-03-2009
DOI: 10.1503/CMAJ.090206
Publisher: Elsevier BV
Date: 2009
DOI: 10.1016/J.RESUSCITATION.2008.10.009
Abstract: To study the rate of documentation of vital signs in the period before the occurrence of an adverse event or emergency team call and to measure the effect of introducing the medical emergency team (MET) system on the rate of such documentation. During a cluster, randomised trial of the MET in 23 Australian hospitals, we collected the data on lowest systolic blood pressure, highest and lowest respiratory rate and heart rate from 15min to 24h before an adverse event (cardiac arrest, death or unexpected intensive care unit admission) or emergency team call. We derived the document of these vital signs (yes/no) from the numerical values recorded. We used analytically weighted and random-effect regression models to examine the association between non-documented (missing) vital signs, hospital characteristics and MET allocation, and to examine their trend over time. We found marked variability in documentation, with a high proportion of missing vital signs in some hospitals. Close to 77% of patients suffering adverse events had at least one vital sign missing immediately before the event. Allocation to a MET system was associated with significantly increased documentation of respiratory rate and blood pressure before emergency team review (P<0.01) as well as an improvement in documentation over time (P<0.01). At all stages and for both MET and control hospitals, the respiratory rate was the least commonly documented vital sign (P<0.01). The documentation of vital signs in the period before adverse events was commonly incomplete with a particular deficiency in the documentation of the respiratory rate. Introduction of a MET system was associated with improvement in the rate of documentation of vital signs.
Publisher: Wiley
Date: 16-01-2018
Abstract: Sepsis is characterised by organ dysfunction resulting from infection, with no reliable single objective test and current diagnosis based on clinical features and results of investigations. In the ED, investigations may be conducted to diagnose infection as the cause of the presenting illness, identify the source, distinguish sepsis from uncomplicated infection (i.e. without organ dysfunction) and/ or risk stratification. Appropriate s le collection for microbiological testing remains key for subsequent confirmation of diagnosis and rationalisation of antimicrobials. Routine laboratory investigations such as creatinine, bilirubin, platelet count and lactate are now critical elements in the diagnosis of sepsis and septic shock. With no biomarker sufficiently validated to rule out bacterial infection in the ED, there remains substantial interest in biomarkers representing various pathogenic pathways. New technologies for screening multiple genes and proteins are identifying unique network 'signatures' of clinical interest. Other future directions include rapid detection of bacterial DNA in blood, genes for antibiotic resistance and EMR-based computational biomarkers that collate multiple information sources. Reliable, cost-effective tests, validated in the ED to promptly and accurately identify sepsis, and to guide initial antibiotic choices, are important goals of current research efforts.
Publisher: Public Library of Science (PLoS)
Date: 12-05-2017
Publisher: Elsevier BV
Date: 03-2022
Publisher: Springer Science and Business Media LLC
Date: 13-04-1999
Abstract: To document the outcome of patients treated with barbiturate coma for severe symptomatic angioplasty-resistant vasospasm. To compare mortality with that predicted by admission APACHE II score, and neurological outcome with that of historical controls treated with barbiturate coma for vasospasm, and with historical controls with delayed ischaemic deficits from vasospasm treated with nimodipine. Cohort study. Neurosurgical Intensive Care Unit of tertiary referral university teaching hospital. Eleven (6.7%) of 164 consecutive patients with aneurysmal SAH managed according to our protocol who were treated with thiopentone-induced burst suppression coma for severe symptomatic, angioplasty-resistant vasospasm. Chart, database and literature review. All 11 patients survived to hospital discharge (mortality 0%) compared with first-day APACHE II predicted mortality of 30.6% (p=0.15). Outcome at 6 months was: good recovery 8/11 (72.7%), moderate disability 2/11 (18.2%), vegetative survival 1/11 (9.1%). Ten of 11 (90.9%) had a good neurological outcome compared with 50.6% of historical controls with delayed ischaemic deficit from vasospasm (odds ratio 9.78, 95% confidence interval 1.24-77.0, p=0.02), and 0% of previously reported patients treated with barbiturate coma for vasospasm (p < 0.01). Our results are better than previously published outcomes and suggest formal evaluation of barbiturate coma in the treatment of severe resistant symptomatic vasospasm following SAH is warranted.
Publisher: Elsevier BV
Date: 12-2008
DOI: 10.1016/J.RESUSCITATION.2008.07.021
Abstract: To examine NFR orders in relation to adverse events and emergency team calls in hospitals with or without a Medical Emergency Team (MET) system during the MERIT study. Within a cluster randomized controlled trial (the MERIT study), examining the effect of introducing a MET system, we recorded NFR orders in relation to adverse events and emergency team calls. We compared the proportion and rate of NFR orders issued in relation to "adverse events" and "adverse event-free emergency team calls" in hospitals with or without a MET system. Information on NFR orders was available for 3650 patients who died, 1466 patients who had an unplanned ICU admission, 574 patients who suffered a cardiac arrest and 1529 patients who had a adverse event-free emergency team call. Close to 90% of deaths occurred in patients with a previously documented NFR order. Only approximately 4% of cardiac arrests had a previously documented NFR order. In patients with unplanned ICU admission, NFR orders were present in approximately 3% of cases. An NFR order was issued at the time of an "event" in 3.85% of cases in MET hospitals compared with 1.72% in control hospitals (OR=2.29 95% CI: 1.31-4.01 p=0.005). This difference was mostly due to a greater proportion of patients being made NFR in MET hospitals at the time of a "adverse event-free" emergency team call (7.96% vs. 3.05% OR=2.75 95% CI: 0.97-7.80 p=0.048). The number of NFR orders issued at the time of a serious adverse event-free emergency team call was 10 times higher in MET hospitals (0.398 vs. 0.041 per 1000 admissions weighted absolute risk difference: 0.49 (95% CI: 0.20-0.78 p=0.002). Multivariate models could only account for less than 50% of the variance in the issuing of NFR orders. In a cohort of Australian hospitals, most deaths occurred in patients with a previously documented NFR order but NFR orders were uncommon before cardiac arrest calls or unplanned ICU admissions. During the conduct of a cluster randomised controlled trial, more NFR orders were issued by emergency teams in those hospitals that implemented a MET system than in control hospitals. MET allocation, teaching hospital status, number of hospital beds and metropolitan location could only explain less than 50% of variance in NFR orders.
Publisher: Elsevier BV
Date: 06-2005
Publisher: Massachusetts Medical Society
Date: 03-08-2017
DOI: 10.1056/NEJMP1707170
Publisher: Elsevier BV
Date: 04-2004
Publisher: Springer Science and Business Media LLC
Date: 2008
DOI: 10.1186/CC6837
Publisher: Elsevier BV
Date: 06-2022
DOI: 10.51893/2022.2.OA3
Abstract: OBJECTIVE: Pregnancy is a risk factor for acute respiratory failure (ARF) following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We hypothesised that SARS-CoV-2 viral load in the respiratory tract might be higher in pregnant intensive care unit (ICU) patients with ARF than in non-pregnant ICU patients with ARF as a consequence of immunological adaptation during pregnancy. DESIGN: Single-centre, retrospective observational case–control study. SETTING: Adult level 3 ICU in a French university hospital. PARTICIPANTS: Eligible participants were adults with ARF associated with coronavirus disease 2019 (COVID-19) pneumonia. MAIN OUTCOME MEASURE: The primary endpoint of the study was viral load in pregnant and non-pregnant patients. RESULTS: 251 patients were included in the study, including 17 pregnant patients. Median gestational age at ICU admission amounted to 28 + 3/7 weeks (interquartile range [IQR], 26 + 1/7 to 31 + 5/7 weeks). Twelve patients (71%) had an emergency caesarean delivery due to maternal respiratory failure. Pregnancy was independently associated with higher viral load (–4.6 ± 1.9 cycle threshold P 0.05). No clustering or over-represented mutations were noted regarding SARS-CoV-2 sequences of pregnant women. Emergency caesarean delivery was independently associated with a modest but significant improvement in arterial oxygenation, amounting to 32 ± 12 mmHg in patients needing invasive mechanical ventilation. ICU mortality was significantly lower in pregnant patients (0 v 35% P 0.05). Age, Simplified Acute Physiology Score (SAPS) II score, and acute respiratory distress syndrome were independent risk factors for ICU mortality, while pregnancy status and virological variables were not. CONCLUSIONS: Viral load was substantially higher in pregnant ICU patients with COVID-19 and ARF compared with non-pregnant ICU patients with COVID-19 and ARF. Pregnancy was not independently associated with ICU mortality after adjustment for age and disease severity.
Publisher: Elsevier BV
Date: 12-2005
DOI: 10.1016/J.JCRC.2005.09.010
Abstract: There is no randomized trial comparing low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) for thromboprophylaxis in medical-surgical ICU patients. The primary objective of this randomized pilot study on LMWH vs UFH was to assess the feasibility of conducting a large randomized trial with respect to timely enrollment and blinded study drug administration, practicality of twice-weekly lower limb ultrasounds to screen for deep venous thrombosis, LMWH bioaccumulation and dose adjustment in renal insufficiency, and recruitment rates for a future trial in medical-surgical intensive care unit (ICU) patients. Its additional goals were to evaluate the suitability of the exclusion criteria and to document the range of research activities that precede accrual of patients into a trial to plan multisite management. By computerized telephone randomization, we allocated 129 medical-surgical ICU patients to treatment with dalteparin 5,000 IU QD SC or that with UFH 5,000 IU BID SC. Within each clinical center, only the study pharmacist was not blinded. We performed bilateral lower limb compression ultrasounds within 48 hours of ICU admission, twice weekly, on suspicion of deep venous thrombosis, and 7 days after ICU discharge. Research coordinators and investigators at 7 centers reported the time they engaged in all research activities before the first patient was randomized. Timely complete study drug administration occurred after enrollment. More than 99% of scheduled doses were administered in a blinded fashion. Scheduled ultrasounds were performed without exception. No bioaccumulation of dalteparin was observed when creatinine clearance decreased to lower than 30 mL/min. Average recruitment was 2 patients/center per month before the study exclusion criteria were modified. Study startup activities required, on average, 65.5 hours of combined investigator and research coordinator time at each center. Careful examination of the accrual in the pilot study led to a reexamination of the Prophylaxis of Thromboembolism in Critical Care Trial (PROTECT) study exclusion criteria. This pilot study suggests that a multicenter randomized clinical trial comparing LMWH with UFH in critically ill medical-surgical patients is feasible. Pilot studies can improve the design of larger trials and may enhance successful timely completion.
Publisher: BMJ
Date: 10-10-2014
DOI: 10.1136/NEURINTSURG-2014-011403
Abstract: Severe angiographic vasospasm (aVSP) is a risk factor for poor functional outcome following subarachnoid hemorrhage. We investigated the impact of angiographic surveillance and intensive endovascular treatment using transluminal balloon angioplasty (TBA) and/or verapamil infusion for severe aVSP through comparison of clinical outcomes in patients of similar presenting grade but with no/mild vasospasm. This was an analysis of prospectively acquired clinical trial data. World Federation of Neurosurgical Societies (WFNS) grade 1-2 patients presenting within 72 h were included. Angiographic screening for vasospasm was undertaken at days 5-7 or in response to clinical deterioration. Severe aVSP was defined as >50% luminal narrowing on digital subtraction angiography. Treatment was instituted on the basis of radiographic findings and/or clinical deterioration. Discharge destination and favorable clinical outcomes (discharge Glasgow Outcome Score (GOS) 4-5, 90 day modified Rankin Scale (mRS) score 0-2, and GOS 4-5) for patients with severe aVSP were compared with those without significant vasospasm. Statistical analysis was undertaken using Fisher's exact test. 63 WFNS grade 1-2 patients with minimal vasospasm were compared with 17 WFNS grade 1-2 patients with severe aVSP treated with induced hypertension and endovascular therapy. Results were available in 62 and 16 patients, respectively. Rates of favorable outcome did not differ significantly between the two groups. For patients with treated severe vasospasm, 90 day mRS 0-2 was seen in 15/17 (88.2%) and GOS 4-5 was achieved in 16/17 (94.1%). An intensive endovascular approach of TBA and/or intra-arterial verapamil in combination with induced hypertension for severe aVSP may result in comparable clinical outcomes to those without vasospasm.
Publisher: Springer Science and Business Media LLC
Date: 27-06-2018
DOI: 10.1007/S00134-018-5274-X
Abstract: To determine differences in health-related quality of life (HRQoL), survival and healthcare resource use of critically ill adults with and without sepsis. We conducted a primary propensity score matched analysis of patients with and without sepsis enrolled in a large multicentre clinical trial. Outcomes included HRQoL at 6 months, survival to 2 years, length of ICU and hospital admission and cost of ICU and hospital treatment to 2 years. We obtained linked data for 3442 (97.3%) of 3537 eligible patients and matched 806/905 (89.0%) patients with sepsis with 806/2537 (31.7%) without. After matching, there were no significant differences in the proportion of survivors with and without sepsis reporting problems with mobility (37.8% vs. 38.7%, p = 0.86), self-care (24.7% vs. 26.0%, p = 0.44), usual activities (44.5% vs. 46.8%, p = 0.28), pain/discomfort (42.4% vs. 41.6%, p = 0.54) and anxiety/depression (36.9% vs. 37.7%, p = 0.68). There was no significant difference in survival at 2 years: 482/792 (60.9%) vs. 485/799 (60.7%) (HR 1.01, 95% CI 0.86-1.18, p = 0.94). The initial ICU and hospital admission were longer for patients with sepsis: 10.1 ± 11.9 vs. 8.0 ± 9.8 days (p < 0.0001) and 22.8 ± 21.2 vs. 19.1 ± 19.0 days, (p = 0.0003) respectively. The cost of ICU admissions was higher for patients with sepsis: A$43,345 ± 46,263 (€35,109 ± 35,043) versus 34,844 ± 38,281 (€28,223 ± 31,007), mean difference $8501 (€6885), 95% CI $4342-12,660 (€3517 ± 10,254), p < 0.001 as was the total cost of hospital treatment to 2 years: A$74,120 ± 60,750 (€60,037 ± 49,207) versus A$65,806 ± 59,856 (€53,302 ± 48,483), p = 0.005. Critically ill patients with sepsis have higher healthcare resource use and costs but similar survival and HRQoL compared to matched patients without sepsis.
Publisher: American Medical Association (AMA)
Date: 28-12-2021
Publisher: Research Square Platform LLC
Date: 31-03-2023
DOI: 10.21203/RS.3.RS-2718088/V1
Abstract: Objective To report trends in Australian hospitalisations coded for sepsis and their associated costs. Design: Retrospective analysis of Australian national hospitalisation data from 2002 to 2021. Methods Sepsis-coded hospitalisations were identified using the Global Burden of Disease study sepsis-specific ICD-10 codes modified for Australia. Costs were calculated using Australian-Refined Diagnosis Related Group codes and National Hospital Cost Data Collection. Results Sepsis-coded hospitalisations increased from 36,628 in 2002-03 to 131,826 in 2020-21, an annual rate of 7.8%. Principal admission diagnosis codes contributed 13,843 (37.8%) in 2002-03 and 44,186 (33.5%) in 2020-21 secondary diagnosis codes contributed 22,785 (62.2%) in 2002-03 and 87,640 (66.5%) in 2020-21. Unspecified sepsis was the most common sepsis code, increasing from 15,178 hospitalisations in 2002-03 to 68,910 in 2020-21. The population-based incidence of sepsis-coded hospitalisations increased from 18.6 per 10,000 population (2002-03) to 51.3 per 10,000 (2021-21) representing an increase from 55.1 per 10,000 hospitalisations in 2002-03 to 111.4 in 2020-21. Sepsis-coded hospitalisations occurred more commonly in the elderly those aged 65 years or above accounting for 20,573 (55.6%) sepsis-coded hospitalisations in 2002-03 and 86,135 (65.3%) in 2020-21. The cost of sepsis-coded hospitalisations increased at an annual rate of 20.6%, from AUD199M (€127M) in financial year 2012 to AUD711M (€455M) in 2019. Conclusion Hospitalisations coded for sepsis and associated costs increased significantly from 2002 to 2021 and from 2012 to 2019, respectively.
Publisher: Springer Science and Business Media LLC
Date: 17-08-2016
Publisher: BMJ
Date: 05-2023
DOI: 10.1136/BMJOPEN-2022-070966
Abstract: Clinically important upper gastrointestinal bleeding is conventionally defined as bleeding accompanied by haemodynamic changes, requiring red blood cell transfusions or other invasive interventions. However, it is unclear if this clinical definition reflects patient values and preferences. This protocol describes a study to elicit views from patients and families regarding features, tests, and treatments for upper gastrointestinal bleeding that are important to them. This is a sequential mixed-methods qualitative-dominant multi-centre study with an instrument-building aim. We developed orientation tools and educational materials in partnership with patients and family members, including a slide deck and executive summary. We will invite intensive care unit (ICU) survivors and family members of former ICU patients to participate. Following a virtual interactive presentation, participants will share their perspectives in an interview or focus group. Qualitative data will be analysed using inductive qualitative content analysis, wherein codes will be derived directly from the data rather than using preconceived categories. Concurrent data collection and analysis will occur. Quantitative data will include self-reported demographic characteristics. This study will synthesise the values and perspectives of patients and family members to create a new trial outcome for a randomised trial of stress ulcer prophylaxis. This study is planned for May 2022 to August 2023. The pilot work was completed in Spring 2021. This study has ethics approval from McMaster University and the University of Calgary. Findings will be disseminated via manuscript and through incorporation as a secondary trial outcome on stress ulcer prophylaxis. NCT05506150 .
Publisher: Springer Science and Business Media LLC
Date: 11-01-2013
DOI: 10.1007/S00134-012-2800-0
Abstract: In acute kidney injury patients, metabolic acidosis is common. Its severity, duration, and associated changes in mean arterial pressure (MAP) and vasopressor therapy may be affected by the intensity of continuous renal replacement therapy (CRRT). We aimed to compare key aspects of acidosis and MAP and vasopressor therapy in patients treated with two different CRRT intensities. We studied a nested cohort of 115 patients from two tertiary intensive care units (ICUs) within a large multicenter randomized controlled trial treated with lower intensity (LI) or higher intensity (HI) CRRT. Levels of metabolic acidosis at randomization were similar [base excess (BE) of -8 ± 8 vs. -8 ± 7 mEq/l p = 0.76]. Speed of BE correction did not differ between the two groups. However, the HI group had a greater increase in MAP from baseline to 24 h (7 ± 3 vs. 0 ± 3 mmHg p < 0.01) and a greater decrease in norepinephrine dose (from 12.5 to 3.5 vs. 5 to 2.5 μg/min p < 0.05). The correlation (r) coefficients between absolute change in MAP and norepinephrine (NE) dose versus change in BE were 0.05 and -0.37, respectively. Overall, LI and HI CRRT have similar acid-base effects in patients with acidosis. However, HI was associated with greater improvements in MAP and vasopressor requirements (clinical trial no. NCT00221013).
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2017
DOI: 10.1097/CCM.0000000000002010
Abstract: To determine rates and predictors of albumin administration, and estimated costs in hospitalized adults in the United States. Cohort study of adult patients from the University HealthSystem Consortium database from 2009 to 2013. One hundred twenty academic medical centers and 299 affiliated hospitals. A total of 12,366,264 hospitalization records. Analysis of rates and predictors of albumin administration, and estimated costs. Overall the proportion of admissions during which albumin was administered increased from 6.2% in 2009 to 7.5% in 2013 absolute difference 1.3% (95% CI, 1.30–1.40% p 0.0001). The increase was greater in surgical patients from 11.7% in 2009 to 15.1% in 2013 absolute difference 3.4% (95% CI, 3.26–3.46% p 0.0001). Albumin use varied geographically being lowest with no increase in hospitals in the North Eastern United States (4.9% in 2009 and 5.3% in 2013) and was more common in bigger ( 750 beds 5.2% in 2009 and 7.3% in 2013) compared to smaller hospitals ( 250 beds 4.4% in 2009 to 6.2% in 2013). Factors independently associated with albumin use were appropriate indication for albumin use (odds ratio, 65.220 95% CI, 62.459–68.103) surgical admission (odds ratio, 7.942 95% CI, 7.889–7.995) and high severity of illness (odds ratio, 8.933 95% CI, 8.825–9.042). Total estimated albumin cost significantly increased from $325 million in 2009 to $468 million in 2013 (absolute increase of $233 million), p value less than 0.0001. The proportion of hospitalized adults in the United States receiving albumin has increased, with marked, and currently unexplained, geographic variability and variability by hospital size.
Publisher: Elsevier BV
Date: 05-2021
DOI: 10.1016/J.AUCC.2021.05.006
Abstract: The aim of the study was to determine whether adjunctive hydrocortisone reduced healthcare expenditure and was cost-effective compared with placebo in New Zealand patients in the Adjunctive Glucocorticoid Therapy in Patients with Septic Shock (ADRENAL) trial. This is a health economic analysis using data linkage to New Zealand Ministry of Health databases to determine resource use, costs, and cost-effectiveness for a 24-month period. The study was conducted in New Zealand. Patients with septic shock were randomised to receive a 7-day continuous infusion of 200 mg of hydrocortisone or placebo in the ADRENAL trial. Healthcare expenditure was associated with all hospital admissions, emergency department presentations, outpatient visits, and pharmacy expenditure. Effectiveness outcomes included mortality at 6 months and 24 months and quality of life at 6 months. Cost-effectiveness outcomes were assessed with reference to quality-adjusted life years gained at 6 months and life years gained at 24 months. Of 3800 patients in the ADRENAL trial, 419 (11.0%) were eligible, and 405 (96.7% of those eligible) were included. The mean total costs per patient over 24 months were $143,627 ± 100,890 and $143,772 ± 97,117 for the hydrocortisone and placebo groups, respectively (p = 0.99). Intensive care unit costs for the index admission were $50,492 and $62,288 per patient for the hydrocortisone and placebo groups, respectively (p = 0.09). The mean number of quality-adjusted life years gained at 6 months and mean number of life years gained at 24 months was not significantly different by treatment group, and the probability of hydrocortisone being cost-effective was 55% at 24 months. In New Zealand, adjunctive hydrocortisone did not reduce total healthcare expenditure or improve outcomes compared with placebo in patients with septic shock.
Publisher: Mary Ann Liebert Inc
Date: 15-12-2020
Publisher: Massachusetts Medical Society
Date: 15-08-2013
DOI: 10.1056/NEJME1304035
Publisher: Oxford University Press (OUP)
Date: 06-10-2016
DOI: 10.2522/PTJ.20160196
Abstract: There is increasing interest in measuring the quality of survivorship for patients admitted to the intensive care unit for acute respiratory failure (ARF). However, there is substantial variability in patient outcomes reported in studies evaluating these patients, with few data on which outcomes are essential to inform clinical practice. The objectives of this study were to determine clinicians’ perspectives on the outcome domains that should always be reported in studies evaluating people who have had ARF after hospital discharge and to compare findings about US and Australian perspectives. A modified Delphi method was used for the study. A survey with 19 possible domains was developed to iteratively elicit clinicians’ perspectives on core outcome domains via a modified Delphi method. The survey was initially administered online. The survey results were then discussed independently at meetings at scientific conferences in the United States and Australia, and the survey was repeated at the meetings after the discussions. The numbers of participants who responded to both the online and the real-time polling were 44 of 100 (44%) in the United States and 78 of 85 (92%) in Australia. Most respondents were intensive care unit–based clinicians (United States: 33 [75%] Australia: 76 [97%]). For the 19 domains evaluated, both US and Australian groups ranked physical function and symptoms as the most important domain, with quality of life, cognitive function and symptoms, and survival being the next 3 most important domains. These data yielded a total of 4 domains meeting the criteria for inclusion as core domains at both meetings. Several key constituencies, including patients and caregivers, were not represented in this study their perspectives are also important and ideally should be included in the development of a comprehensive core outcome set. Clinicians agreed that physical function and symptoms, quality of life, cognitive function, and survival were domains that should always be measured in research evaluating outcomes for people who have had ARF after hospital discharge.
Publisher: Elsevier BV
Date: 2020
Publisher: Massachusetts Medical Society
Date: 03-03-2022
Publisher: Wiley
Date: 09-06-2015
DOI: 10.1111/NEP.12488
Abstract: While patients with chronic kidney disease have reduced health-related quality of life (HRQOL), long-term HRQOL of survivors of severe acute kidney injury (AKI) remains unclear. We analysed HRQOL from the Prolonged Outcomes Study of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (POST-RENAL) study and compared findings with those from a general Australian adult population enrolled in the Australian Diabetes, Obesity and Lifestyle (AusDiab) study. We used a multivariate analysis adjusted for baseline characteristics along with sensitivity analysis using age and sex-matched case controls. In the POST-RENAL study, 282 participants had HRQOL data collected using the SF-12 questionnaire. This was compared with 6330 participants from the AusDiab study. Unadjusted analyses showed that POST-RENAL participants had lower physical component scores (PCS, mean score 40.0 vs 49.8, P<0.0001) and lower mental component scores (MCS, mean score 49.8 vs 53.9, P<0.0001) than the AusDiab group. After age and sex matching, the difference in PCS and MCS remained statistically significant (P<0.0001). Advanced age, reduced renal function and albuminuria (all P ≤ 0.01) were all strongly associated with lower PCS values but not MCS values. After matching subsets of the cohorts on the basis of age, sex and renal function, PCS and MCS were lower in the POST-RENAL group (P<0.0001). Survivors of severe AKI in the POST-RENAL study had lower physical and mental components of HRQOL compared with general population, even after adjustment for their reduced renal function. Increasing age and reduced renal function were associated with poorer physical QOL.
Publisher: American Medical Association (AMA)
Date: 15-11-2022
Abstract: The effectiveness of selective decontamination of the digestive tract (SDD) in critically ill adults receiving mechanical ventilation is uncertain. To determine whether SDD is associated with reduced risk of death in adults receiving mechanical ventilation in intensive care units (ICUs) compared with standard care. The primary search was conducted using MEDLINE, EMBASE, and CENTRAL databases until September 2022. Randomized clinical trials including adults receiving mechanical ventilation in the ICU comparing SDD vs standard care or placebo. Data extraction and risk of bias assessments were performed in duplicate. The primary analysis was conducted using a bayesian framework. The primary outcome was hospital mortality. Subgroups included SDD with an intravenous agent compared with SDD without an intravenous agent. There were 8 secondary outcomes including the incidence of ventilator-associated pneumonia, ICU-acquired bacteremia, and the incidence of positive cultures of antimicrobial-resistant organisms. There were 32 randomized clinical trials including 24 389 participants in the analysis. The median age of participants in the included studies was 54 years (IQR, 44-60), and the median proportion of female trial participants was 33% (IQR, 25%-38%). Data from 30 trials including 24 034 participants contributed to the primary outcome. The pooled estimated risk ratio (RR) for mortality for SDD compared with standard care was 0.91 (95% credible interval [CrI], 0.82-0.99 I 2 = 33.9% moderate certainty) with a 99.3% posterior probability that SDD reduced hospital mortality. The beneficial association of SDD was evident in trials with an intravenous agent (RR, 0.84 [95% CrI, 0.74-0.94]), but not in trials without an intravenous agent (RR, 1.01 [95% CrI, 0.91-1.11]) ( P value for the interaction between subgroups = .02). SDD was associated with reduced risk of ventilator-associated pneumonia (RR, 0.44 [95% CrI, 0.36-0.54]) and ICU-acquired bacteremia (RR, 0.68 [95% CrI, 0.57-0.81]). Available data regarding the incidence of positive cultures of antimicrobial-resistant organisms were not amenable to pooling and were of very low certainty. Among adults in the ICU treated with mechanical ventilation, the use of SDD compared with standard care or placebo was associated with lower hospital mortality. Evidence regarding the effect of SDD on antimicrobial resistance was of very low certainty.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2010
Publisher: Springer Science and Business Media LLC
Date: 05-05-2020
DOI: 10.1186/S13063-020-04279-1
Abstract: Randomised controlled trials (RCT) may be hindered by slow recruitment rates, particularly in critically ill patients. While statistical models to predict recruitment rates have been described, no systematic assessment has been conducted of the distribution of recruitment across sites, temporal trends in site participation and impact of competing trials on patient recruitment. We used recruitment and screening logs from the SAFE, NICE-SUGAR, RENAL, CHEST and ADRENAL trials, five of the largest critical care RCTs. We quantified the extent of recruitment asymmetry between sites using Lorenz curves and Gini coefficients and assessed whether the recruitment distribution across sites follow the Pareto principle, which states that 80% of effects come from 20% of causes. Peak recruitment rates and growth in participating sites were calculated. In total, 25,412 patients were randomised in 99 intensive care units (ICUs) for the five trials. Distribution of recruitment was asymmetric, with a small number of ICUs recruiting a large proportion of the patients. The Gini coefficients ranged from 0.14 to 0.52. The time to peak recruitment rate ranged from 7 to 41 months and was variable (7, 31, 41, 10 and 40 months). Over time, the proportion of recruitment at non-tertiary ICUs increased from 15% to 34%. There is asymmetry of recruitment with a small proportion of ICUs recruiting a large proportion of patients. The distributions of recruitment were not consistent with the Pareto principle. There has been increasing participation of non-tertiary ICUs in clinical trials.
Publisher: Massachusetts Medical Society
Date: 12-03-2020
Publisher: Springer Science and Business Media LLC
Date: 18-07-2002
DOI: 10.1007/S00134-002-1399-Y
Abstract: To report the occurrence of life-threatening hyperkalaemia following treatment with therapeutic thiopentone coma. The neurosurgical intensive care units of Royal North Shore Hospital and Liverpool Hospital, Sydney, Australia. Three patients treated with theraputic thiopentone coma. One patient with raised intracranial pressure secondary to a severe traumatic brain injury and two patients with refractory vasospasm secondary to subarachnoid haemorrhage. Two of the three patients developed hypokalaemia on starting thiopentone, which was resistant to potassium supplementation. All three patients developed severe hyperkalaemia during the recovery phase of coma. This was life-threatening in all three patients and fatal in one. Severe hypokalaemia refractory to potassium therapy may occur during therapeutic thiopentone coma. Severe rebound hyperkalaemia may occur after cessation of thiopentone infusion. Protocols for the management of patients with therapeutic barbiturate coma should recognise this potentially serious complication.
Publisher: SAGE Publications
Date: 02-2003
DOI: 10.1177/0310057X0303100117
Abstract: The management of vasospasm associated with traumatic subarachnoid haemorrhage presents many challenges. We present a 20-year-old male admitted after sustaining a closed head injury complicated by a Fisher grade III traumatic subarachnoid haemorrhage. Despite treatment with intravenous nimodipine he developed a delayed ischaemic neurological deficit due to cerebral arterial vasospasm. The vasospasm was successfully managed with serial papaverine angioplasty.
Publisher: American Medical Association (AMA)
Date: 17-12-2008
Publisher: SAGE Publications
Date: 08-1997
DOI: 10.1177/0310057X9702500405
Abstract: This study reports the incidence of bacteraemia following 106 consecutive bedside percutaneous tracheostomies. Post-tracheostomy blood culture results were compared with other blood cultures from the same population. The incidence of positive post-tracheostomy blood cultures was 10.4% (11/106), compared with 6.6% (7/106) for other blood cultures (odds ratio 1.64, 95% confidence interval 0.61-4.40, P=0.46). Staphylococcus epidermidis was the most common organism cultured, 7/106 (6.6%) of post-tracheostomy cultures, compared with 3/106 (2.8%) for other cultures (odds ratio 2.43, 95% confidence interval 0.61-9.65, P=0.33). The other four post-tracheostomy cultures grew an organism cultured from that patient's tracheal secretions. Seventy-four patients were receiving antibiotics at the time of tracheostomy, of these 7 (9.5%) had positive blood cultures, a similar incidence (4 of 32, 12.5%) to those not receiving antibiotics (odds ratio 0.73, 95% confidence interval 0.20-2.70, P=0.90). We conclude bacteraemia is a common complication of percutaneous tracheostomy the causative organisms come from the patients’ trachea or skin.
Publisher: American Medical Association (AMA)
Date: 17-12-2008
Abstract: Evidence demonstrates that providing nutritional support to intensive care unit (ICU) patients within 24 hours of ICU admission reduces mortality. However, early feeding is not universally practiced. Changing practice in complex multidisciplinary environments is difficult. Evidence supporting whether guidelines can improve ICU feeding practices and patient outcomes is contradictory. To determine whether evidence-based feeding guidelines, implemented using a multifaceted practice change strategy, improve feeding practices and reduce mortality in ICU patients. Cluster randomized trial in ICUs of 27 community and tertiary hospitals in Australia and New Zealand. Between November 2003 and May 2004, 1118 critically ill adult patients expected to remain in the ICU longer than 2 days were enrolled. All participants completed the study. Intensive care units were randomly assigned to guideline or control groups. Guideline ICUs developed an evidence-based guideline using Browman's Clinical Practice Guideline Development Cycle. A practice-change strategy composed of 18 specific interventions, leveraged by educational outreach visits, was implemented in guideline ICUs. Hospital discharge mortality. Secondary outcomes included ICU and hospital length of stay, organ dysfunction, and feeding process measures. Guideline and control ICUs enrolled 561 and 557 patients, respectively. Guideline ICUs fed patients earlier (0.75 vs 1.37 mean days to enteral nutrition start difference, -0.62 [95% confidence interval {CI}, -0.82 to -0.36] P < .001 and 1.04 vs 1.40 mean days to parenteral nutrition start difference, -0.35 [95% CI, -0.61 to -0.01] P = .04) and achieved caloric goals more often (6.10 vs 5.02 mean days per 10 fed patient-days difference, 1.07 [95% CI, 0.12 to 2.22] P = .03). Guideline and control ICUs did not differ with regard to hospital discharge mortality (28.9% vs 27.4% difference, 1.4% [95% CI, -6.3% to 12.0%] P = .75) or to hospital length of stay (24.2 vs 24.3 days difference, -0.08 [95% CI, -3.8 to 4.4] P = .97) or ICU length of stay (9.1 vs 9.9 days difference, -0.86 [95% CI, -2.6 to 1.3] P = .42). Using a multifaceted practice change strategy, ICUs successfully developed and introduced an evidence-based nutritional support guideline that promoted earlier feeding and greater nutritional adequacy. However, use of the guideline did not improve clinical outcomes. Trial Registration anzctr.org.au Identifier: ACTRN12608000407392.
Publisher: Springer Science and Business Media LLC
Date: 11-11-2022
DOI: 10.1038/S41597-022-01784-7
Abstract: In recent years, the machine learning research community has benefited tremendously from the availability of openly accessible benchmark datasets. Clinical data are usually not openly available due to their confidential nature. This has h ered the development of reproducible and generalisable machine learning applications in health care. Here we introduce the Health Gym - a growing collection of highly realistic synthetic medical datasets that can be freely accessed to prototype, evaluate, and compare machine learning algorithms, with a specific focus on reinforcement learning. The three synthetic datasets described in this paper present patient cohorts with acute hypotension and sepsis in the intensive care unit, and people with human immunodeficiency virus (HIV) receiving antiretroviral therapy. The datasets were created using a novel generative adversarial network (GAN). The distributions of variables, and correlations between variables and trends in variables over time in the synthetic datasets mirror those in the real datasets. Furthermore, the risk of sensitive information disclosure associated with the public distribution of the synthetic datasets is estimated to be very low.
Publisher: Elsevier BV
Date: 03-2023
Publisher: SAGE Publications
Date: 02-1989
DOI: 10.1177/0310057X8901700110
Abstract: The cardiovascular responses to tracheal intubation using a fibreoptic bronchoscope or Macintosh laryngoscope were compared in twenty in-patients and twenty day-stay patients. Within these groups patients were randomly allocated to direct laryngoscopic or fibreoptic bronchoscopic intubation. Arterial blood pressure, heart rate and arterial oxygen saturation were recorded before induction and at one-minute intervals until four minutes after intubation. In both groups both laryngoscopic and bronchoscopic intubation resulted in a significant rise in blood pressure and heart rate. At no stage was there a significant difference in mean blood pressure in either group, or in heart rate in the day-stay patients, between the different methods of intubation. In the in-patients mean heart rate was significantly higher in those patients intubated with the bronchoscope at three and four minutes after intubation. Time taken for intubation was significantly longer in those patients intubated with the bronchoscope. In no patient did the arterial oxygen saturation fall below 98%.
Publisher: Massachusetts Medical Society
Date: 04-07-2019
DOI: 10.1056/NEJMC1905933
Publisher: BMJ
Date: 07-12-1996
Publisher: IEEE
Date: 07-2015
Publisher: Elsevier BV
Date: 07-2009
Publisher: Elsevier BV
Date: 02-2018
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC12537
Publisher: BMJ
Date: 26-07-2023
Publisher: Elsevier BV
Date: 07-2018
Publisher: Massachusetts Medical Society
Date: 20-07-2017
DOI: 10.1056/NEJMC1703337
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2008
Publisher: Springer Science and Business Media LLC
Date: 24-04-2020
Publisher: Springer Science and Business Media LLC
Date: 2010
DOI: 10.1186/CC9293
Publisher: Massachusetts Medical Society
Date: 17-04-2014
DOI: 10.1056/NEJMC1402402
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2010
DOI: 10.2215/CJN.09111209
Publisher: Research Square Platform LLC
Date: 27-06-2023
DOI: 10.21203/RS.3.RS-3084525/V1
Abstract: Purpose To determine the proportion of critically ill patients with and without sepsis who exhibit persistent lymphopenia and examine its relationship with hospital survival. Methods Database analysis of adult intensive care unit (ICU) patients at two hospitals in Queensland, Australia and the MIMIC III database from Boston, USA. Results We defined persistent lymphopenia at two thresholds (absolute lymphocyte count [ALC] .0 and .75 x 10 9 /L) based on two qualifying values recorded during the first four days in ICU. In the USA cohort 27,646/32,528 (85.0%) patients did not have two ALCs recorded with evidence that data were not missing at random consequently, we report the analysis of the Australian cohort. In the Australian cohort 7605/8507 (89.4%) patients had two ALCs recorded, of these 1482 (19.5%) had sepsis. Persistent lymphopenia (ALC .0) was present in 728/1482 (49.1%) and 2302/6123 (37.6%) of patients with and without sepsis, respectively. For ALC .75 the results were 487/1482 (32.9%) and 1125/6123 (18.4%), respectively. 562/3030 (18.5%) patients with persistent lymphopenia (ALC .0) died in hospital compared with 439/4575 (9.6%) patients without persistent lymphopenia. Persistent lymphopenia was an independent risk factor for in hospital death in all patients. The hazard ratio for death at ALC .0 was 1.89 (95%CI 1.31 – 2.85) and 1.17 (1.02 – 1.36) in patients with and without sepsis respectively. Conclusions Persistent lymphopenia is common in critically ill patients and associated with increased risk of death. The association is stronger in patients with sepsis. Trials testing the hypothesis that reversing lymphopenia reduces mortality should initially target patients with sepsis.
Publisher: Elsevier BV
Date: 06-09-2021
DOI: 10.51893/2021.3.OA11
Abstract: OBJECTIVE: To estimate the incidence and outcomes of sepsis hospitalisations in Aboriginal and Torres Strait Islander and non-Indigenous residents of New South Wales. DESIGN AND PARTICIPANTS: Prospective cohort study of residents aged 45 years and older, recruited between 2006 and 2009, and followed for hospitalisation for sepsis. MAIN OUTCOME MEASURES: Incidence and hazard ratio (HR) of sepsis hospitalisation and intensive care unit (ICU) admission identified using International Classification of Diseases (10th revision) coding on discharge data. Length of stay, readmission and mortality in those admitted for sepsis. RESULTS: Of 264 678 participants, 1928 (0.7%) identified as Aboriginal and/or Torres Strait Islander. Sepsis hospitalisation was higher in Aboriginal and Torres Strait Islander participants (8.67 v 6.12 per 1000 person-years age- and sex-adjusted HR, 2.35 95% CI, 1.98–2.80) but was attenuated after adjusting for sociodemographic factors, health behaviour and comorbidities (adjusted HR, 1.56 95% CI, 1.31–1.86). Among those hospitalised for sepsis, after adjusting for age and sex, there were no differences between the proportions of Aboriginal and Torres Strait Islander and non-Indigenous participants admitted to an ICU (18.0% v 16.1% P = 0.42) or deceased at 1 year (36.1% v 36.8% P = 0.92). Aboriginal and Torres Strait Islander participants had shorter lengths of hospital stay (9.98 v 11.72 days P 0.001) and ICU stay (4.38 v 6.35 days P 0.001) than non-Indigenous participants. Overall, more than 70% of participants were readmitted to hospital within 1 year. CONCLUSION: We found that the rate of sepsis hospitalisation in NSW was higher for Aboriginal and Torres Strait Islander adults. Culturally appropriate, community-led strategies targeting chronic disease prevention and the social determinants of health may reduce this gap. Preventing readmission following sepsis is a priority for all Australians.
Publisher: Springer Science and Business Media LLC
Date: 03-08-2016
Publisher: Springer Science and Business Media LLC
Date: 06-2023
Publisher: Massachusetts Medical Society
Date: 13-01-2011
DOI: 10.1056/NEJMC1012158
Publisher: American Medical Association (AMA)
Date: 27-08-2008
Publisher: Massachusetts Medical Society
Date: 26-03-2009
Publisher: Elsevier BV
Date: 10-1994
DOI: 10.1093/BJA/73.4.499
Abstract: We have assessed the acute effects of inhaled nitric oxide 8, 32 and 128 volumes per million (vpm) on pulmonary haemodynamics and arterial oxygenation in patients with severe acute respiratory failure. Fourteen patients requiring artificial ventilation with mean pulmonary artery pressures greater than 30 mm Hg were given inhaled nitric oxide haemodynamic values and blood-gas tensions were measured before and after 10 min of inhalation of nitric oxide. Nitric oxide inhaled at 8, 32 and 128 vpm decreased mean pulmonary artery pressure by 1.7 (SD 2.2), 3.2 (2.6) and 3.3 (3.3) mm Hg, pulmonary vascular resistance by 20 (64), 53 (57) and 66 (54) dyn s cm-5 and increased arterial oxygen tension by 2.5 (3.6), 3.0 (5.1) and 2.9 (3.9) kPa, respectively. All changes were significant (P < 0.05 or less) except for changes in pulmonary vascular resistance at 8 vpm. The improvement in arterial oxygenation with 128 vpm was related to pulmonary vascular resistance before commencing nitric oxide. The major beneficial effect of nitric oxide in acute respiratory failure would appear to be improvement in oxygenation rather than reduction in pulmonary artery pressure. The degree of improvement in arterial oxygenation with nitric oxide was related directly to pulmonary vascular resistance before treatment.
Publisher: SAGE Publications
Date: 04-2006
DOI: 10.1177/0310057X0603400217
Abstract: We aimed to estimate the potential number of patients eligible for treatment with drotrecogin alfa (activated) when applying different international criteria. The study was a post-hoc analysis of inception cohort study of 691 patients with severe sepsis during 5878 consecutive intensive care unit admission episodes in 23 closed multi-disciplinary ICUs of 21 hospitals (16 tertiary and 5 university-affiliated) in Australia and New Zealand. Outcomes assessed were presence of contraindications to treatment with drotrecogin alfa (activated), an admission APACHE II score of 25 or greater and dysfunction of two or more organs. During 5878 consecutive intensive care admission episodes, 691 patients had severe sepsis, 553 (80.0%, 95% CI 77.0–83.0%) had no relative or absolute contraindication, 64 (9.3%, 7.1–11.4%)) had a relative contraindication and 74 (10.7%, 8.4–13.0%) had an absolute contraindication. Two hundred and six patients (3.5%, 3.0–4.0%) had an APACHE II score of 25 or greater, 452 (7.7%, 7.0–8.4%) had dysfunction of two or more organs, 469 (8.0%, 7.3–8.7%) had either dysfunction of two or more organs or an APACHE II score of 25 or greater. Relatively few patients had an absolute contraindication to treatment with drotrecogin alfa (activated). Selection based on the APACHE II score results in fewer eligible patients than selection based on multiple organ dysfunction. Depending on the selection criteria used, for every hundred admissions to intensive care, between 3.5 and 8.0 of patients may be eligible for treatment with drotrecogin alfa (activated).
Publisher: American Medical Association (AMA)
Date: 26-11-2014
Abstract: Venous thromboembolism (VTE) is a common complication of acute illness, and its prevention is a ubiquitous aspect of inpatient care. A multicenter blinded, randomized trial compared the effectiveness of the most common pharmocoprevention strategies, unfractionated heparin (UFH) and the low-molecular-weight heparin (LMWH) dalteparin, finding no difference in the primary end point of leg deep-vein thrombosis but a reduced rate of pulmonary embolus and heparin-induced thrombocytopenia among critically ill medical-surgical patients who received dalteparin. To evaluate the comparative cost-effectiveness of LMWH vs UFH for prophylaxis against VTE in critically ill patients. Prospective economic evaluation concurrent with the Prophylaxis for Thromboembolism in Critical Care Randomized Trial (May 2006 to June 2010). The economic evaluation adopted a health care payer perspective and in-hospital time horizon derived baseline characteristics and probabilities of intensive care unit and in-hospital events and measured costs among 2344 patients in 23 centers in 5 countries and applied these costs to measured resource use and effects of all enrolled patients. Costs, effects, incremental cost-effectiveness of LMWH vs UFH during the period of hospitalization, and sensitivity analyses across cost ranges. Hospital costs per patient were $39,508 (interquartile range [IQR], $24,676 to $71,431) for 1862 patients who received LMWH compared with $40,805 (IQR, $24,393 to $76,139) for 1862 patients who received UFH (incremental cost, -$1297 [IQR, -$4398 to $1404] P = .41). In 78% of simulations, a strategy using LMWH was most effective and least costly. In sensitivity analyses, a strategy using LMWH remained least costly unless the drug acquisition cost of dalteparin increased from $8 to $179 per dose and was consistent among higher- and lower-spending health care systems. There was no threshold at which lowering the acquisition cost of UFH favored prophylaxis with UFH. From a health care payer perspective, the use of the LMWH dalteparin for VTE prophylaxis among critically ill medical-surgical patients was more effective and had similar or lower costs than the use of UFH. These findings were driven by lower rates of pulmonary embolus and heparin-induced thrombocytopenia and corresponding lower overall use of resources with LMWH.
Publisher: AMPCo
Date: 22-07-2019
DOI: 10.5694/MJA2.50279
Publisher: AMPCo
Date: 06-2008
DOI: 10.5694/J.1326-5377.2008.TB01825.X
Abstract: The level of documentation of vital signs in many hospitals is extremely poor, and respiratory rate, in particular, is often not recorded. There is substantial evidence that an abnormal respiratory rate is a predictor of potentially serious clinical events. Nurses and doctors need to be more aware of the importance of an abnormal respiratory rate as a marker of serious illness. Hospital systems that encourage appropriate responses to an elevated respiratory rate and other abnormal vital signs can be rapidly implemented. Such systems help to raise and sustain awareness of the importance of vital signs.
Publisher: Wiley
Date: 16-12-2022
DOI: 10.1111/IMCB.12611
Abstract: Sepsis is a global health priority, yet effective host‐directed targeted therapies have not been identified outside of the setting of coronavirus disease 2019 (COVID‐19). Lymphopenia occurs in up to ~52% of patients with sepsis and is associated with a higher mortality at both 30 and 100 days. In COVID‐19, the presence of lymphopenia correlates with intensive care unit admission, acute respiratory distress syndrome and death. The mechanisms underpinning lymphopenic sepsis remain unknown, and while high rates of lymphocyte apoptosis have been implicated, the relative contributions of cellular trafficking to inflamed tissues and reduction in lymphopoiesis require investigation. Further delineation of these underlying mechanisms holds the potential to open new avenues for the development of host‐directed therapies in lymphopenic sepsis. These may include recombinant cytokines (e.g. interleukin‐7), monoclonal antibodies (e.g. anti‐interleukin‐1, anti‐programmed cell death protein 1) and small interfering RNA (e.g. targeting interleukin‐10, transforming growth factor beta). Applying the frontier tools of translational cellular and genomic medicine to understand lymphopenia in the setting of critical infections holds the potential to significantly reduce the excessive global burden of sepsis.
Publisher: Elsevier BV
Date: 12-1991
DOI: 10.1093/BJA/67.6.784
Abstract: The presence of an intracranial neoplasm (ICN) during pregnancy has serious implications for the anaesthetic management of labour and delivery. The physiological changes of pregnancy and labour are potentially hazardous to women with ICN, but the provision of adequate pain relief during labour reduces the risk to the mother. Extradural anaesthesia is the only technique that provides pain-free labour reliably, but it carries added risks. Three patients are reported who were managed with extradural anaesthesia: two delivered per vaginam and one by Caesarean section. None suffered any complication related to the anaesthetic technique. At present, there are no published data on the influence of anaesthetic management on outcome of labour and delivery in patients with ICN. Anaesthetists should report such cases so that the relative risks of different management strategies may be assessed.
Publisher: American Thoracic Society
Date: 09-2022
Publisher: American Thoracic Society
Date: 15-10-2019
Publisher: Elsevier BV
Date: 06-2022
DOI: 10.1016/J.JINF.2022.04.035
Abstract: To examine the association of sex with hospitalisation due to sepsis and related outcomes. Prospective cohort study of 264,678 adults, average age 62.7 years at recruitment (2006-2009) in Australia. Participants were followed for sepsis hospitalisation identified using the International Classification of Diseases coding. Outcomes included sex differences in the risk of an incident sepsis hospitalisation, mortality, length of ICU and hospital stay and readmissions during the following year. Over 2,070,343 years of follow-up there were 12,912 sepsis hospitalisations, 59.6% in men. Age-standardised risk of hospitalisation was higher in men versus women (10.37 vs 6.77 per 1,000 person years age-adjusted HR 1.58 95% CI 1.53-1.59) and did not attenuate after adjusting for sociodemographics, health behaviours and co-morbidities. Relative risks were similar for sepsis-related ICU admissions (adjusted HR 1.72 95% CI 1.57-1.88). Death at one year was more common in men than women (39.3% vs 33.7% p<0.001). After adjusting for age, men had a longer hospital (12.0 vs 11.2 days p<0.001) and ICU (6.5 vs 5.8 days p<0.001) stays and were more likely to be readmitted to hospital for sepsis (22.3 vs 19.4% p<0.001) or any reason (73.0% vs 70.7% p<0.001) at one year. In older adults, compared to women, men are at an increased risk of sepsis hospitalisation, sepsis-related ICU admission, death and readmission to hospital within one year after a sepsis hospitalisation. Understanding these sex differences and their mechanisms may offer opportunities for better prevention and management and improved patient outcomes.
Publisher: SAGE Publications
Date: 10-1996
DOI: 10.1177/0310057X9602400511
Abstract: It is now widely accepted that mechanical ventilation may damage the lung, but the mechanism of lung damage is not clear. Possible causes include overdistension of aerated alveoli by inappropriately large tidal volumes (volutrauma), shear stresses generated during the recruitment and de-recruitment of lung units at the junction of aerated and collapsed lung, and infective or ischaemic necrosis of persistently collapsed lung. Computerized tomography allows noninvasive assessment of lung structure during and after acute lung injury, and may provide insight into the mechanism of lung damage. Using serial high resolution computed tomography we documented lung structure one month after recovery from severe protracted adult respiratory distress syndrome (ARDS) in three patients who required mechanical ventilation for between 86 and 97 days the computed tomograms were repeated at between 5 and 14 months. All three patients had persistent abnormalities of lung structure which were most marked in the anterior regions of the lung. These findings suggest that overdistension of non-dependent lung regions is the main mechanism of lung damage persisting after recovery from severe protracted ARDS.
Publisher: Springer Science and Business Media LLC
Date: 03-06-2015
DOI: 10.1007/S00134-015-3878-Y
Abstract: Recent evidence indicates that the choice of intravenous fluids may affect outcomes in critically ill patients. We recorded the administration of resuscitation fluids in patients admitted to Australian and New Zealand adult intensive care units (ICUs) for a 24-h period at 6 time points between 2007 and 2013. Changes in patterns of fluid use over this period were determined using regression analyses. Of the 2825 patients admitted to the 61 ICUs on the 6 study days, 754 (26.7%) patients received fluid resuscitation. Of those receiving fluid resuscitation, the proportion of patients receiving crystalloid significantly increased from 28.9% (41/142) in 2007 to 50.5% (48/95) in 2013 (adjusted odds ratio (OR) 2.93 95% confidence intervals (CI) 1.35-6.33 p = 0.006) of these, the proportion of patients receiving buffered salt solutions significantly increased from 4.9% (7/142) in 2007 to 31.6% (30/95) in 2013 (OR 7.00 95% CI 2.14-22.92 p = 0.001). The use of colloids significantly decreased from 59.9% (85/142) in 2007 to 42.1% (40/95) in 2013 (adjusted OR 0.34 95% CI 0.16-0.74 p = 0.007) due to a significant decrease in the proportion of patients receiving gelatin 28.9% (41/142) to 2.1% (2/95) (OR 0.10 95% CI 0.03-0.29 p ≤ 0.001). Fluid resuscitation practice in Australia and New Zealand adult ICUs has changed over the 6-year study period. Crystalloid use increased primarily due to an increase in the use of buffered salt solutions while overall the use of colloid has decreased.
Publisher: Springer Science and Business Media LLC
Date: 09-02-2023
Publisher: Massachusetts Medical Society
Date: 30-08-2018
DOI: 10.1056/NEJMC1804993
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-2016
Publisher: AMPCo
Date: 05-1999
Publisher: Elsevier BV
Date: 03-2021
DOI: 10.51893/2021.1.OA2
Abstract: BACKGROUND AND OBJECTIVE:The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. METHODS: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. RESULTS AND CONCLUSIONS: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.
Publisher: Springer Science and Business Media LLC
Date: 27-06-2018
DOI: 10.1007/S12028-018-0566-0
Abstract: Consensus on appropriate outcome measures to use in aneurysmal subarachnoid hemorrhage (aSAH) research has not been established, although the transition toward a core outcome set (COS) would provide significant benefits. To inform COS development, we conducted a systematic review to identify outcome measures included in reports of randomized clinical trials (RCTs) of interventions in patients with aSAH. Ovid Medline, EMBASE, CINAHL, and CENTRAL were searched. RCTs investigating aSAH published between January 1996 and May 2015 were included. The primary and secondary outcomes of RCTs were recorded and classified according to the OMERACT Consortium's framework. We identified 1093 potential studies of which 129 met inclusion criteria representing 24 238 patients. There were 285 unique outcome measures. The Glasgow Outcome Scale (GOS) was the most frequently used primary outcome (13/129, 10.1%). Mortality was reported in 84 trials (65.1%) with 3 months the most common time point (34/129, 26.4%). The GOS (65/129, 50.4%) and the Modified Rankin Scale (51/129, 39.5%) were the most commonly reported functional measures however, these were reported at different time points and often dichotomized using different ranges. Patient-reported quality of life measures were used in 11 trials (8.5%). Transcranial Doppler was the most frequently used imaging modality (40/129, 31.0%). Definitions and reporting of vasospasm, delayed cerebral ischemia and imaging modality results were highly variable. The marked heterogeneity of outcomes in reports of RCTs supports the development of a core outcome set for aSAH trials. Our study has identified a wide range of outcomes for potential inclusion in a future aSAH COS.
Publisher: Elsevier BV
Date: 06-2012
DOI: 10.1016/J.JCRC.2011.10.007
Abstract: Randomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment. Six Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month. Fifty-one patients were enrolled 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%). Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.
Publisher: BMJ
Date: 15-03-2003
Publisher: Massachusetts Medical Society
Date: 15-11-2012
Publisher: BMJ
Date: 13-10-2013
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2011
Publisher: BMJ
Date: 24-06-2009
DOI: 10.1136/BMJ.B2418
Publisher: Springer Science and Business Media LLC
Date: 2014
DOI: 10.1186/CC13767
Publisher: Springer Science and Business Media LLC
Date: 10-09-2018
Publisher: Springer Science and Business Media LLC
Date: 29-06-2021
Publisher: Elsevier BV
Date: 07-2011
Abstract: Hyperglycemia is common in critically ill patients, with approximately 90% of patients treated in an ICU developing blood glucose concentrations > 110 mg/dL (6.1 mmol/L). Landmark trials in Leuven, Belgium, suggested that targeting normoglycemia (a blood glucose concentration of 80-110 mg/dL [4.4-6.1 mmol/L]) reduced mortality and morbidity, but other investigators have not been able to replicate these findings. Recently, the international multicenter Normoglycemia in Intensive Care Evaluation-Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study reported increased mortality with this approach, and recent meta-analyses do not support intensive glucose control for critically ill patients. Although the initial trials in Leuven produced enthusiasm and recommendations for intensive blood glucose control, the results of the NICE-SUGAR study have resulted in the more moderate recommendation to target a blood glucose concentration between 144 mg/dL and 180 mg/dL (8-10 mmol/L). As critical care practitioners pay greater attention to glycemic control, it has become clear that currently used point-of-care measuring systems are not accurate enough to target tight glucose control. Unresolved issues include whether increased blood glucose variability is inherently harmful and whether even moderate hypoglycemia can be tolerated in the quest for tighter blood glucose control. Future research must first address whether intensive glucose control can be delivered safely, and whether computerized decision support systems and newer technologies that allow accurate and continuous or near-continuous measurement of blood glucose can make this possible. Until such time, clinicians would be well advised to abide by the age-old adage to "first, do no harm."
Publisher: SAGE Publications
Date: 12-05-2015
Abstract: Hyperglycemia and hypoglycemia are associated with adverse clinical outcomes in intensive care patients. In product development studies at 4 ICUs, the safety and performance of an intravascular continuous glucose monitoring (IV-CGM) system was evaluated in 70 postsurgical patients. The GluCath System (GluMetrics, Inc) used a quenched chemical fluorescence mechanism to optically measure blood glucose when deployed via a radial artery catheter or directly into a peripheral vein. Periodic ultrasound assessed blood flow and thrombus formation. Patient glucose levels were managed according to the standard of care and existing protocols at each site. Reference blood s les were acquired hourly and compared against prospectively calibrated sensor results. In all, 63 arterial sensors and 9 venous sensors were deployed in 70 patients. Arterial sensors did not interfere with invasive blood pressure monitoring, s ling or other aspects of patient care. A majority of venous sensors (66%) exhibited thrombus on ultrasound. In all, 89.4% (1383/1547) of arterial and 72.2% (182/252) of venous measurements met ISO15197:2003 criteria (within 20%), and 72.7% (1124/1547) of arterial and 56.3% (142/252) of venous measurements met CLSI POCT 12-A3 criteria (within 12.5%). The aggregate mean absolute relative difference (MARD) between the sensors and the reference was 9.6% for arterial and 14.2% for venous sensors. The GluCath System exhibited acceptable accuracy when deployed in a radial artery for up to 48 hours in ICU patients after elective cardiac surgery. Accuracy of venous deployment was substantially lower with significant rates of intravascular thrombus observed using ultrasound.
Publisher: Elsevier BV
Date: 06-2010
DOI: 10.1016/J.JCRC.2009.12.011
Abstract: The purpose of the study was to examine triggers for emergency team activation in hospitals with or without a medical emergency team (MET) system. Within a cluster randomized controlled trial examining the effect of introducing a MET system, we recorded the triggers for emergency team activation. We compared the proportion and rate of such triggers in hospitals with or without a MET system and in relation to type of hospital, type of patient ward, and time of day. In control hospitals, the most common trigger for emergency team activation was a decrease in Glasgow Coma Score by 2 or more points (45.6%), whereas in MET hospitals, it was the fact that staff members were "worried" or the call occurred despite the lack of a "specified reason" (39.3%). In particular, MET hospitals were 35 times more likely to make a call because of staff being "worried" about the patient (14.1% vs 0.4%, P < .001). Control hospitals were also significantly more likely to call an emergency team because of a deteriorating respiratory (P = .003) or pulse (P < .001) rate, more calls had at least 3 triggers for activation (20.8% vs 10.2%, P = .036), and the average number of triggers per call was significantly higher (P = .013). Nonmetropolitan hospitals were more likely to call an emergency team because of respiratory rate abnormalities (33.6% vs 23.2%, P = .015). Coronary care unit calls were more likely to be triggered by abnormalities in pulse rate and systolic blood pressure, and more calls occurred during the period from 6:00 am to noon. In MET hospitals, more emergency team calls are triggered because staff members are worried about the patient and fewer calls have multiple triggers. Type of hospital, type of ward, and time of day also affect the nature and frequency of triggers for emergency team activation.
Publisher: American Physiological Society
Date: 09-2020
Publisher: Springer Science and Business Media LLC
Date: 13-01-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2009
Publisher: Springer Science and Business Media LLC
Date: 04-2004
DOI: 10.1007/S00134-004-2157-0
Abstract: To determine the population incidence and outcome of severe sepsis occurring in adult patients treated in Australian and New Zealand intensive care units (ICUs), and compare with recent retrospective estimates from the USA and UK. Inception cohort study. Twenty-three closed multi-disciplinary ICUs of 21 hospitals (16 tertiary and 5 university affiliated) in Australia and New Zealand. A total of 5878 consecutive ICU admission episodes. Main outcome measures were population-based incidence of severe sepsis, mortality at ICU discharge, mortality at 28 days after onset of severe sepsis, and mortality at hospital discharge. A total of 691 patients, 11.8 (95% confidence intervals 10.9-12.6) per 100 ICU admissions, were diagnosed with 752 episodes of severe sepsis. Site of infection was pulmonary in 50.3% of episodes and abdominal in 19.3% of episodes. The calculated incidence of severe sepsis in adults treated in Australian and New Zealand ICUs is 0.77 (0.76-0.79) per 1000 of population. 26.5% of patients with severe sepsis died in ICU, 32.4% died within 28 days of the diagnosis of severe sepsis and 37.5% died in hospital. In this prospective study, 11.8 patients per 100 ICU admissions were diagnosed with severe sepsis and the calculated annual incidence of severe sepsis in adult patients treated in Australian and New Zealand ICUs is 0.77 per 1000 of population. This figure for the population incidence falls in the lower range of recent estimates from retrospective studies in the U.S. and the U.K.
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Simon Finfer.