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

Am Heart J. 2024 Jun:272:48-55. doi: 10.1016/j.ahj.2024.02.024. Epub 2024 Mar 2.

Abstract

Background: The enhanced recovery after cardiac surgery is a bundle of measurements from preoperative to postoperative phases to improve patients' recovery.

Methods: This study is a multicenter, stepwise design, cluster randomized controlled trial. About 3,600 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). About 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).

Discussion: This study aims to compare the application of ERAS management protocol and traditional management protocol in adult cardiac surgery under extracorporeal circulation.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Clinical Trial Protocol

MeSH terms

  • Acute Kidney Injury / epidemiology
  • Acute Kidney Injury / etiology
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Surgical Procedures* / adverse effects
  • Cardiac Surgical Procedures* / methods
  • Cardiopulmonary Bypass / methods
  • Enhanced Recovery After Surgery
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Young Adult