Behind the scenes: Key lessons learned from the RELIEVE-AKI clinical trial

Abstract

Continuous kidney replacement therapy (CKRT) is commonly used to manage critically ill patients with severe acute kidney injury. While recent trials focused on the correct dosing and timing of CKRT, our understanding regarding the optimum dose of net ultrafiltration is limited to retrospective data. The Restrictive versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (RELIEVE-AKI) trial has been conducted to assess the feasibility of a prospective randomized trial in determining the optimum net ultrafiltration rate. This paper outlines the relevant challenges and solutions in implementing this complex ICU-based trial. Several difficulties were encountered, starting with clinical issues related to conducting a trial on patients with rapidly changing hemodynamics, low patient recruitment rates, increased nursing workload, and the enormous volume of data generated by patients undergoing prolonged CKRT. Following several brainstorming sessions, several points were highlighted to be considered, including the need to streamline the intervention, add more flexibility in the trial protocols, ensure comprehensive a priori planning, particularly regarding nursing roles and their compensation, and enhance data management systems. These insights are critical for guiding future ICU-based dynamically titrated intervention trials, leading to more efficient trial management, improved data quality, and enhanced patient safety.