The Australasian Resuscitation In Sepsis Evaluation - Randomised Controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$2,424,807.00
Summary
Patients with severe infections often present to Emergency Departments and early treatment with particular fluids, blood transfusions and stimulants, may improve survival rates. To determine whether early treatment is safe and effective in reducing deaths, the Australian and New Zealand Intensive Care Society Clinical Trials Group, in conjunction with the Australasian College of Emergency Medicine, plan to perform a large trial of early goal directed therapy in patients with severe infections.
Early Parenteral Nutrition Vs. Standard Care In The Critically Ill Patient: A Level I Randomised Controlled Trial.
Funder
National Health and Medical Research Council
Funding Amount
$1,852,333.00
Summary
Nutritional support is accepted as a standard of care for the hospitalised patient however there is little agreement as to how it should be provided to the critically ill patient. Despite the fact that studies consistently link malnutrition to worse outcomes, the provision of nutritional support to the critically ill patient is highly variable. Although there is general agreement that it is best to feed critically ill patients via the gastrointestinal tract (stomach tube feeding), there is no ge ....Nutritional support is accepted as a standard of care for the hospitalised patient however there is little agreement as to how it should be provided to the critically ill patient. Despite the fact that studies consistently link malnutrition to worse outcomes, the provision of nutritional support to the critically ill patient is highly variable. Although there is general agreement that it is best to feed critically ill patients via the gastrointestinal tract (stomach tube feeding), there is no general agreement as to when intravenous artificial nutrition should be begun if a patient cannot tolerate a feeding tube. A recent systematic review of all available clinical trials suggests that if a critically ill patient cannot be fed by a stomach tube for at least 24 hours, they may benefit from intravenous artificial nutrition. This is not what currently happens under standard care. The purpose of this multi-centre randomised controlled trial is to determine if early intravenous nutrition saves lives. Because of the cost, and possible risk of increased infections, a study of this type is required before early intravenous nutrition could become a routine therapy in Australia. Informed consent to participate in the study will be obtained from next of kin, or directly from the patient themselves. The study will be managed at the Royal North Shore Hospital, University of Sydney and will include 26 collaborating ANZ hospitals over 18 months.Read moreRead less
How Does Activated Protein C Create Intact, Non-leaky, Stable Blood Vessels?
Funder
National Health and Medical Research Council
Funding Amount
$564,644.00
Summary
Vascular dysfunction is a common feature of many diseases, including sepsis, diabetes, atherosclerosis, tumours and asthma. These vessels have compromised structural and functional integrity, leading to leakage of blood components and causing inflammation in tissues. Based on our recent findings, this project aims to discover how activated protein C creates normal, healthy non-leaky blood vessels and prevents vascular dysfunction in disease.
Multi-centre Randomised Trial Of Early Decompressive Craniectomy In Patients With Severe Traumatic Brain Injury
Funder
National Health and Medical Research Council
Funding Amount
$490,500.00
Summary
Despite optimal neurosurgical and intensive care therapy, many trauma patients with severe brain injury (typically young males) have very poor long term neurological outcomes. Current knowledge suggests that a key contributor to secondary brain damage which occurs after injury and to poor neurological outcomes is brain swelling and subsequent increase in brain pressure. Present intensive care therapies to control brain pressure are often not effective, and favourable neurological outcomes occur ....Despite optimal neurosurgical and intensive care therapy, many trauma patients with severe brain injury (typically young males) have very poor long term neurological outcomes. Current knowledge suggests that a key contributor to secondary brain damage which occurs after injury and to poor neurological outcomes is brain swelling and subsequent increase in brain pressure. Present intensive care therapies to control brain pressure are often not effective, and favourable neurological outcomes occur in only 20-30% of these patients. Small studies suggest that a surgical operation called decompressive craniectomy (DC) may decrease brain pressure and improve neurological outcomes in these patients. DC involves temporarily surgically removing a piece of skull bone (during the swelling period) and replacing it when the swelling has subsided. DC is done under general anaesthetic in unconscious patients and is used occasionally at present, although due to insufficient research the benefits are controversial. The proposed study is a multi-centre randomised controlled study of best current therapies plus early decompressive craniectomy vs best current therapies alone in selected unconscious patients with severe head injury. The study outcome is patient neurological function measured 6 months after the injury. A study of this type is required before early DC could become a routine therapy in Australia. Next of kin will sign informed consent for the study and then also for the surgery if patients are randomised to surgery. The study will be managed at the Alfred Hospital-Monash University in Melbourne and includes fifteen collaborating ANZ neurotrauma centres over 3.0 years. There are >200 patients in Australia annually in this category with potential for DC to increase favourable outcomes in >40 patients annually. Lifetime costs for these patients with severe disability are > $2.4 million, so there may be substantial economic and social impact.Read moreRead less
A Randomised, Placebo-controlled Trial Of Erythropoietin In ICU Patients With Traumatic Brain Injury
Funder
National Health and Medical Research Council
Funding Amount
$1,950,735.00
Summary
Patients who suffer a moderate or severe head injury (traumatic brain injury) have a 50% chance of having a long term neurological disability or death. Erythropoietin is a medication which encourages red blood cell formation but its other beneficial effects are likely to improve outcomes after traumatic brain injury. This study will examine the safety and effects of erythropoietin on long term neurological function in patients who have suffered a traumatic brain injury.
Randomised Comparison Of Fluid Resuscitation With Human Albumin Solution Or Normal Saline Among Critically Ill Patients
Funder
National Health and Medical Research Council
Funding Amount
$611,728.00
Summary
Human albumin solution is widely used for the emergency treatment of severely ill patients requiring fluid replacement, both in Australia and worldwide. However, a recent report suggests that compared to the other standard treatment (salt solution), the use of human albumin solution may be associated with a higher death rate (about six additional deaths among every one hundred patients treated). But, this report was based on data from a relatively small number of patients among whom there was a ....Human albumin solution is widely used for the emergency treatment of severely ill patients requiring fluid replacement, both in Australia and worldwide. However, a recent report suggests that compared to the other standard treatment (salt solution), the use of human albumin solution may be associated with a higher death rate (about six additional deaths among every one hundred patients treated). But, this report was based on data from a relatively small number of patients among whom there was a relatively small number of deaths, and there is widespread uncertainty among doctors about the reliability of the evidence and the implications for patient care. This is reflected in the large difference between intensive care units in the use of human albumin solution (in Australia, its use ranges from 10-90% of all patients needing fluid). Human albumin solution costs, about thirty times more than salt solution, and during 1998 more than 200,000 bottles of human albumin solution were administered to patients in Australia, at a cost of about A$35 million. In an effort to provide definitive evidence about the effects (and cost-effectiveness) of fluid replacement with human albumin solution, the Australia and New Zealand Intensive Care Society, in collaboration with the Australian Red Cross Blood Services and the Institute for International Health, has proposed the conduct of new large-scale study (SAFE - Saline vs Albumin Fluid Evaluation). This study will involve 7,000 patients from 15 intensive care units in Australia and New Zealand. These patients (all of whom require fluid replacement) will be randomly assigned to receive either human albumin solution or salt solution and outcome in terms of deaths and other serious events will be monitored over 28 days. Results will be available within 2 years of starting the study, and these are likely to influence the care of the majority of seriously ill patients admitted to intensive care units worldwide.Read moreRead less
A Randomised Controlled Trial Of Normoglycaemia Versus Conventional Glycaemic Control In Intensive Care Unit Patients.
Funder
National Health and Medical Research Council
Funding Amount
$1,773,507.00
Summary
The concentration of sugar in the blood is often increased in patients in intensive care and patients with increased blood sugar levels are more likely to die. A recent study performed in a Belgian intensive care unit found that using high doses of insulin to lower blood sugars levels to normal increased the number of patients who survived. The chance of surviving to leave hospital was increased from 89% to 93%. Whilst the result is very encouraging, Intensive Care Specialists in Australia are u ....The concentration of sugar in the blood is often increased in patients in intensive care and patients with increased blood sugar levels are more likely to die. A recent study performed in a Belgian intensive care unit found that using high doses of insulin to lower blood sugars levels to normal increased the number of patients who survived. The chance of surviving to leave hospital was increased from 89% to 93%. Whilst the result is very encouraging, Intensive Care Specialists in Australia are unsure if the treatment would work in their patients because of differences in the types of patients found in intensive care units in Australia, and because of other treatment given to the patients in the Belgian study. In particular the doctors in the Belgian unit studied only patients who had had operations and gave large amounts of intravenous sugar to their patients. This is not normally done in Australian Intensive Care Units and the safety of giving high dose insulin to patients not receiving large amounts of intravenous sugar is not known. This is of particular interest as reducing blood glucose to abnormally low levels can cause serious side effects and even result in permanent brain damage. The Australian and New Zealand Intensive Care Society proposes to conduct a new study involving 4,000 patients from intensive care units in Australia and New Zealand and will study all patients regardless of whether or not they have had an operation. These patients will be randomly assigned to receive insulin to control blood sugar levels to normal or to slightly above normal levels as has been tradition in intensive care units around the world. Outcome and serious side effects will be closely monitored. The results will be available within three years of starting the study, and these are likely to influence the treatment of the majority of patients admitted to intensive care units both in Australia and worldwide.Read moreRead less
Multicentre, Open Label, Randomised, Controlled Trial Of Severe ARF Management With An Augmented Vs Normal CRRT Regimen
Funder
National Health and Medical Research Council
Funding Amount
$1,879,125.00
Summary
Sudden serious kidney failure is a major problem that frequently occurs in patients who are in Intensive Care. For these patients, their chances of survival are significantly decreased. In Australia sudden serious kidney failure is usually treated with continuous kidney support by a kidney machine. A recent study found that by using greater than normal levels of kidney support, that is , running larger volumes of fluid through the kidney machine, patients in Intensive Care Units (ICU's) may be l ....Sudden serious kidney failure is a major problem that frequently occurs in patients who are in Intensive Care. For these patients, their chances of survival are significantly decreased. In Australia sudden serious kidney failure is usually treated with continuous kidney support by a kidney machine. A recent study found that by using greater than normal levels of kidney support, that is , running larger volumes of fluid through the kidney machine, patients in Intensive Care Units (ICU's) may be less likely to die from their sudden serious kidney failure. Despite these positive findings, this high level of kidney support is not commonly used in Australian ICU's. Clearly though, if greater than normal levels of kidney support do increase the chances that individuals will live, then patients should be receiving this treatment. The Australia and New Zealand Intensive Care Society, in conjunction with The George Institute for International Health, propose to conduct a new study involving 1500 patients from ICU's throughout Australia, who require continuous kidney support due to sudden serious kidney failure. These patients will be randomly assigned so that half receive the normally used levels of kidney support and the other half receive kidney support at greater than normal levels. Patients will then be followed for three months to compare the proportions of patients who die in each group. All other outcomes and serious side effects will be closely monitored throughout the study. The results will be available to the public within four years of starting the study, and these are likely to influence the treatment of patients admitted to ICU's with sudden serious kidney failure, not only in Australia but also worldwide.Read moreRead less
A Phase II Randomised Controlled Trial Of Atorvastatin Therapy In Intensive Care Patients With Severe Sepsis
Funder
National Health and Medical Research Council
Funding Amount
$622,148.00
Summary
Infections are common in patients in the intensive care unit and produce inflammation that may spread throughout the body. Despite improved therapies, when infections cause failure of the body's vital organs, up to 40% of patients may die. The medication atorvastatin and other statins have been used for many years to treat and prevent conditions such as heart attack and stroke. They act primarily by reducing cholesterol production. In addition, they also modify inflammation and the immune system ....Infections are common in patients in the intensive care unit and produce inflammation that may spread throughout the body. Despite improved therapies, when infections cause failure of the body's vital organs, up to 40% of patients may die. The medication atorvastatin and other statins have been used for many years to treat and prevent conditions such as heart attack and stroke. They act primarily by reducing cholesterol production. In addition, they also modify inflammation and the immune system which may make them a useful treatment for patients with established infections. Although the statin drugs are usually safe, rare side effects may affect muscle and the liver. Because of concerns about increased risk of side effects it is currently recommended that statins should be stopped when patients become unwell. However, a number of studies have suggested that patients on statins for heart disease are less likely to develop infections and that their infections are less likely to be severe or result in death. Other studies have suggested that stopping statins in patients that present with infections (as suggested by current guidelines), may worsen infection outcomes. However, these studies have not been detailed enough to exclude all factors affecting outcome, such as patient age, severity of the infection, and the presence of other diseases. We plan to perform a study to assess the effect of atorvastatin on the outcome of infections in the intensive care unit. We will study 250 patients presenting with severe infections. We will randomly assign patients to receive either atorvastatin or placebo and monitor the effect on signs of inflammation and levels of life support. Outcomes and side effects will be carefully monitored. The study will help us decide whether to perform a larger study to determine if atorvastatin can reduce the risk of dying from serious infections.Read moreRead less
Impact Of Gastrointestinal Dysmotility On Enteral Nutrition In The Critically Ill
Funder
National Health and Medical Research Council
Funding Amount
$533,792.00
Summary
Critically ill patients require nutrition for optimum recovery. Ideally, this is provided via the gut, but oesophageal reflux, slow gastric emptying and small intestinal dysfunction frequently prevent adequate delivery of nutrients to these patients, exposing them to complications such as pneumonia and gastrointestinal bleeding. The work performed by the applicants will improve the ability of doctors in the Intensive Care Unit to feed patients and prevent the development of such complications.