NCT02568722

Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)

STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,019 (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 to standard initiation, leads to: 1. Improved survival (primary outcome); and 2. Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

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% 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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Standard RRT initiation	In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops: serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-10-06
• Last updated: 2024-10-18
• Results posted: 2024-10-18

Locations

105 sites across 15 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Finland, France, Germany, Ireland, Italy, New Zealand, Switzerland, United Kingdom