Selection of endpoints for clinical trials of acute renal failure in critically ill patients.

The selection of appropriate outcome measures is essential to the design of clinical trials of the prevention or treatment of acute renal failure in critically ill patients. In this paper, we present the consensus opinion from the second Acute Dialysis Quality Initiative Conference held in Vicenza, Italy, in May 2002, regarding the issues that should guide the selection of endpoints in clinical intervention trials of acute renal failure. Important criteria for the selection of these outcome measures include their clinical importance, responsiveness to experimental intervention, precision of definition, accuracy of measurement, and completeness of ascertainment. Although the most appropriate endpoints for individual studies are dependent on specific hypotheses and study designs, the primary endpoint in prevention trials should be based on an assessment of renal function, whereas mortality or renal functional assessment may serve as the primary endpoint in studies of established acute renal failure.