The protocol of enhanced recovery after cardiac surgery in adult patients: A stepped wedge cluster randomized trial

Abstract

BackgroundThe Enhanced Recovery After Cardiac Surgery is a bundle of measurements from preoperative to postoperative phases to improve patients’ recovery. MethodsThis study is a multicenter, stepwise design, cluster randomized controlled trial. 3600 patients presenting during control and intervention periods are eligible if they are aged from 18 to 80 years old awaiting elective cardiac surgery with cardiopulmonary bypass (CPB). 5 centers are randomly assigned to staggered start dates for one-way crossover from the control phase to the intervention phase. In the intervention periods, patients will receive ERAS strategy including preoperative, intraoperative and postoperative approaches. During the control phase, patients receive usual care. The primary outcome consists of major adverse cardiac and cerebrovascular events (MACCEs), postoperative pulmonary complications (PPCs), and acute kidney injury (AKI). DiscussionThis study aims to compare the application of ERAS management protocol and traditional management protocol in adult cardiac surgery under extracorporeal circulation.