ACTIVE Dialysis: A Clinical Trial Of IntensiVE Dialysis
Funder
National Health and Medical Research Council
Funding Amount
$1,310,836.00
Summary
People with kidney disease requiring dialysis have substantially reduced life expectancy, poorer health status and quality of life. Better treatments are therefore urgently required. ACTIVE Dialysis is a clinical trial that will assess whether increased duration of dialysis improves these critical outcomes. A formal cost-effectiveness analysis will be conducted from a health system perspective.
RCT Of Aspirin And Fish Oil For The Prevention Of Thrombosis In Arterio-venous Fistulae For Dialysis Access
Funder
National Health and Medical Research Council
Funding Amount
$1,869,190.00
Summary
This randomised, placebo-controlled clinical trial aims to determine whether the anti-platelet agents aspirin and fish oil, either alone or in combination, will effectively reduce the risk of early thrombosis (blood clots) in arterio-venous fistulae (AVF) that are used for accessing the circulatory system in dialysis. The trial is to be conducted by the Australasian Kidney Trials Network (AKTN). 1200 patients requiring haemodialysis who are scheduled to undergo creation of an AVF and are not cur ....This randomised, placebo-controlled clinical trial aims to determine whether the anti-platelet agents aspirin and fish oil, either alone or in combination, will effectively reduce the risk of early thrombosis (blood clots) in arterio-venous fistulae (AVF) that are used for accessing the circulatory system in dialysis. The trial is to be conducted by the Australasian Kidney Trials Network (AKTN). 1200 patients requiring haemodialysis who are scheduled to undergo creation of an AVF and are not currently taking anti-platelet agents will be recruited over 3 years. AVF is the accepted standard for haemodialysis patients because it utilises the patient's own artery and vein to allow repeated access to the vascular system with a minimal risk of complications. Failure of the AVF means the use of inferior permanent venous catheters or arterio-venous artificial grafts. These devices are more costly to insert, and have an increased risk of failure due to infection and thrombosis. Reducing this rate of failure by simple, cheap and readily available interventions has the potential to reduce these problems. Aspirin has been chosen because of its well-established anti-thrombosis effects. Fish oil has a number of biological effects which make it an attractive agent for the prevention of vascular access thrombosis. Study treatment will be aspirin 100 mg per day or matching placebo, and fish oil 4 gm daily or matching placebo, both commencing on the day prior to surgery and continued for 3 months. If the trial demonstrates a positive effect of either or both agents, this will lead to a reduction in thromboses, quicker time to working dialysis access, and less need for surgery.Read moreRead less
The IDEAL Trial - Initiating Dialysis Early And Late
Funder
National Health and Medical Research Council
Funding Amount
$752,500.00
Summary
Kidney replacement therapy by dialysis has in the past been provided for patients with endstage renal failure once their remaining kidney function has deterioriated to less than 5-10% of normal. There has been an increasing trend in recent years to offer dialysis therapy at an earlier stage of kidney failure, such that more than 20% of dialysis patients in Australia (and up to 35% in some subgroups) now commence that therapy when their remaining kidney function is greater than 10%. This change h ....Kidney replacement therapy by dialysis has in the past been provided for patients with endstage renal failure once their remaining kidney function has deterioriated to less than 5-10% of normal. There has been an increasing trend in recent years to offer dialysis therapy at an earlier stage of kidney failure, such that more than 20% of dialysis patients in Australia (and up to 35% in some subgroups) now commence that therapy when their remaining kidney function is greater than 10%. This change has occurred because of the unproven belief that earlier dialysis may be associated with a better health outcome. However, dialysis treatment is associated with complications and it is very expensive. Therefore, it is important to determine the health and economic consequences of commencing dialysis early rather than late. The IDEAL trial (Initiating Dialysis Early And Late) is a large multi-centre study being conducted in many renal units in Australia and New Zealand, which will determine whether it is better, in terms of health outcomes and total cost of treatment, to commence dialysis at a time when remaining kidney function is between 10 and 14% or between 5 and 7% of normal.Read moreRead less
This Study aims to answer the question: When is the best time for adults with kidney disease to start dialysis? This question is currently a subject of intense international debate. It has been suggested that patients who commence dialysis relatively early, when they still have a high level of remaining kidney function, have fewer complications, maintain a better level of function in the community and are less likely to die as a result of their kidney disease. However, this has not been determin ....This Study aims to answer the question: When is the best time for adults with kidney disease to start dialysis? This question is currently a subject of intense international debate. It has been suggested that patients who commence dialysis relatively early, when they still have a high level of remaining kidney function, have fewer complications, maintain a better level of function in the community and are less likely to die as a result of their kidney disease. However, this has not been determined in a rigorous scientific manner. In fact starting dialysis earlier may expose the person to the risks associated with the use of dialysis and may also impact on their quality of life. Many international kidney societies have formulated guidelines recommending that dialysis should be commenced early - when the remaining kidney function drops to a level of approximately 10-15% of normal kidney function. Recent practice in Australia and New Zealand has been to commence dialysis when the remaining kidney function is between 6 and 9% of normal. Hence, the adoption of these guidelines recommending an earlier dialysis start time will have a significant impact on health costs; therefore a net benefit to the patient and the community, needs to be demonstrated. To answer this important question, we have designed and instituted a multi-center trial, that was commenced in 2000. The trial has been scientifically designed (randomised controlled trial) to compare the effect of early start dialysis (remaining kidney function between 10-14%) versus late start dialysis (remaining kidney function between 5-7%) on survival, disease and dialysis complications and subsequent hospitalization. To date 748 of the required 800 patients have been entered into the trial and will be followed for a minimum of 3 years. We are confident the results of this trial will impact at a local, national and international level, delineating best practice management of dialysis in people with kidney failure.Read moreRead less