Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury
- Conditions
- Acute Kidney Injury
- Interventions
- Other: Standard RRT initiationOther: Accelerated RRT initiation
- Registration Number
- NCT01557361
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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 with standard initiation, is:
1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
2. Safe, from the perspective of potential adverse events associated with earlier initiation of RRT
- Detailed Description
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%. Delay in the initiation of RRT has been implicated as a possible contributor to this poor outcome. A recent meta-analysis suggested that earlier initiation of RRT may improve survival. However, completed trials to date have been small, single centre, limited by study quality, and have shown considerable heterogeneity in terms of definitions used for "early" RRT initiation.
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 with standard initiation, is:
1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
2. Safe, from the perspective of potential adverse events associated with the earlier or later initiation of RRT
This pilot trial is intended to guide and inform the design of a phase III multicentre randomized trial of accelerated versus standard initiation of RRT in critically ill patients that will evaluate the impact of the intervention on 90-day all-cause mortality and recovery of kidney function.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard RRT initiation Standard RRT initiation RRT is initiated \>12 hours after eligibility determination. Once a decision is made to start RRT, a dialysis catheter will be placed and RRT initiated as soon as possible. Accelerated RRT initiation Accelerated RRT initiation A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility.
- Primary Outcome Measures
Name Time Method Feasibility of protocol adherence 14 days \>90% of participants in the accelerated initiation arm start RRT within 12 hours of eligibility AND \>90% of participants randomized to the standard initiation arm who ultimately receive RRT, start RRT at least 12 hours following eligibility determination
- Secondary Outcome Measures
Name Time Method Feasibility of 90-day follow-up 90 days Vital status and need for RRT at 90 days are successfully captured in \>95% of participants
Feasibility of enrollment 14 days \>50% of eligible patients are successfully enrolled in the trial
Safety outcomes 14 days Serious adverse effects, with a particular focus on those that are potentially attributable to the study treatment, vascular accesss complications (including hemorrhage, thrombosis and infection) and complications associated with the delivery of RRT (dialysis-associated hypotension, electrolyte abnormalities) will be examined.
Trial Locations
- Locations (11)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Ontario, Canada
The Ottawa Hospital, Civic Campus
🇨🇦Ottawa, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
The Ottawa Hospital, General Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Centre hopitalier universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada