The protocol of enhanced recovery after cardiac surgery in adult patients: A stepped wedge cluster randomized trial - 04/05/24

Doi : 10.1016/j.ahj.2024.02.024

Dou Dou, MD ^a, Su Yuan, MD ^a, Yuan Jia, MD ^a, Yang Wang, PhD ^b, Yinan Li, MD ^a, Hongbai Wang, MD ^a, Jie Ding, MD ^a, Xie Wu, MD ^a, Dongyun Bie, MM ^a, Qiao Liu, MD ^a, Ran An, MM ^a, Haoqi Yan, MM ^a, Fuxia Yan, MD ^a,^⁎
^a Department of Anesthesiology, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China
^b Department of Medical Research & Biometrics Centre, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China

^⁎Reprint requests: Fuxia Yan, MD, No. 167 BeilishiRd, Xicheng District, Beijing 100037, China.No. 167 BeilishiRdXicheng DistrictBeijing100037China

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.

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Plan

Implementation of interventions

Data collection and management

Blinding

Discussion

Conclusions

Current status of the trial

Ethics and consent

CRediT authorship contribution statement

Trail Registrationwww.clinicaltrials.gov (NCT05914090).

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Vol 272

P. 48-55 - juin 2024 Retour au numéro

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The protocol of enhanced recovery after cardiac surgery in adult patients: A stepped wedge cluster randomized trial - 04/05/24

ABSTRACT

Background

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Plan

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