NCT01557361

Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury

STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Accelerated RRT initiation	A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
OTHER	Standard RRT initiation	Patients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are: I. Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND II. At least one of the following indications for RRT initiation: 1. Serum potassium ≥6.0 mmol/L, or 2. Serum bicarbonate ≤ 10 mmol/L, or 3. Evidence of severe respiratory failure, based on a PaO2/FiO2 \<200 and bilateral infiltrates on the chest x-ray, or 4. By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2012-03-19
• Last updated: 2014-09-12

Locations

11 sites across 1 country: Canada