End Points for Clinical Trials in Acute Kidney Injury

Abstract

Acute kidney injury (AKI) is an increasingly common and feared complication in hospitalized patients. The selection of appropriate primary and secondary end points is critical to the design and eventual success of clinical trials aimed at preventing and treating AKI. In this article, we provide an overview of AKI definitions and suggestions on the rational selection of end points for clinical trials in various settings, including the prevention of contrast-induced AKI, prevention of cardiac surgery-associated AKI, treatment of established AKI, and treatment of dialysis-requiring AKI.

Keywords: AKDI definition; Acute kidney injury (AKI); acute renal failure (ARF); biomarker; clinical trial; end point; outcome; randomized controlled trial; study design.