The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:
- Improved survival (primary outcome); and
- Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.
Multi-national, multi-center, open-label, randomized controlled trial to compare an accelerated (or early/pre-emptive) approach to the initiation of RRT versus a conservative strategy of initiation of RRT as guided by standard indications and clinical judgement in critically ill patients with AKI.
Two thousand eight hundred sixty six (2866) critically ill patients with evidence of severe AKI, who do not have an urgent indication for RRT initiation at the time of screening but who have a reasonable likelihood of ultimately requiring RRT. Recruitment will occur at centers in Canada, Australia, New Zealand, UK, Austria, Finland, Belgium, France, Germany, USA and potentially several other countries.
For Contact and Location information please click here.