Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial
1 Critical Care Department, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada
2 Keenan Research Centre, Li KaShing Knowledge Institute, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada
3 Division of Nephrology, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada
4 Department of Medicine, University of Toronto, 30 Bond Street, Toronto, ON M5B1W8, Canada
5 Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Room D1.08, 2075 Bayview Avenue, Toronto, ON M4N 3M5, Canada
6 Applied Health Research Centre, Li KaShing Knowledge Institute, St. Michael’s Hospital, 30 Bond Street, Toronto, ON M5B1W8, Canada
7 Division of Nephrology, Western University, London, ON N6A 3K7, Canada
8 University Hospital, ALL-139A 339 Windermere Road, London, ON N6A 5A5, Canada
9 Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 3C1.12 Walter C. Mackenzie Centre, 8440-112 St, Edmonton, NW RILF3 T6G2B7, Canada
Trials 2013, 14:320 doi:10.1186/1745-6215-14-320Published: 5 October 2013
Acute kidney injury is a common and devastating complication of critical illness, for which renal replacement therapy is frequently needed to manage severe cases. While a recent systematic review suggested that “earlier” initiation of renal replacement therapy improves survival, completed trials are limited due to small size, single-centre status, and use of variable definitions to define “early” renal replacement therapy initiation.
This is an open-label pilot randomized controlled trial. One hundred critically ill patients with severe acute kidney injury will be randomly allocated 1:1 to receive “accelerated” initiation of renal replacement therapy or “standard” initiation at 12 centers across Canada. In the accelerated arm, participants will have a venous catheter placed and renal replacement therapy will be initiated within 12 hours of fulfilling eligibility. In the standard initiation arm, participants will be monitored over 7 days to identify indications for renal replacement therapy. For participants in the standard arm with persistent acute kidney injury, defined as a serum creatinine not declining >50% from the value at the time of eligibility, the initiation of RRT will be discouraged unless one or more of the following criteria are fulfilled: serum potassium ≥6.0 mmol/L; serum bicarbonate ≤10 mmol/L; severe respiratory failure (PaO2/FiO2<200) or persisting acute kidney injury for ≥72 hours after fulfilling eligibility. The inclusion criteria are designed to identify a population of critically ill adults with severe acute kidney injury who are likely to need renal replacement therapy during their hospitalization, but not immediately. The primary outcome is protocol adherence (>90%). Secondary outcomes include measures of feasibility (proportion of eligible patients enrolled in the trial, proportion of enrolled patients followed to 90 days for assessment of vital status and the need for renal replacement therapy) and safety (occurrence of adverse events).
The optimal timing of renal replacement therapy initiation in patients with severe acute kidney injury remains uncertain, representing an important knowledge gap and a priority for high-quality research. This pilot trial is necessary to establish protocol feasibility, confirm the safety of participants and obtain estimated events rates for design of a large definitive trial.