The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.

Study Overview

• Status: Completed
• Conditions: ERAS
• Intervention / Treatment: Other: Preoperative Strategies; Other: Intraoperative Strategies; Other: Postoperative Strategies

Detailed Description

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 200000
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200000
      • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 80 years.
• Undergoing elective surgery.
• Scheduled for cardiac valve surgery with cardiopulmonary bypass.
• Body mass index (BMI) between 16.5 and 31 kg/m².
• American Society of Anesthesiologists (ASA) physical status classification of II or III.

Exclusion Criteria:

• Refusal to participate, refusal to sign the informed consent form, or inability to communicate.
• Participation in other clinical trials concurrently.
• Combined coronary artery bypass grafting or ascending aorta surgery.
• Emergency surgery.
• Active infective endocarditis.
• Previous history of cardiac surgery.
• Preoperative presence of neurocognitive disorders (NCD), depression, or other psychiatric conditions.
• Known abuse of alcohol, drugs, or anesthetics.
• Pregnant or breastfeeding women.
• Presence of other serious comorbidities that may impede enrollment or affect survival, such as malignancies or severe disabilities.

Termination of Intervention

Intervention will be terminated for the following reasons:

• Withdrawal of consent and request to exit the trial during the study period.
• Significant changes in surgical approach: including the addition of deep hypothermic circulatory arrest, intra-aortic balloon counterpulsation (IABP) support, extracorporeal membrane oxygenation (ECMO) support, etc.
• Medical necessity for termination of intervention, as determined by the investigator, for example: use of cardiopulmonary bypass more than twice during surgery; unexpected difficulties in weaning from cardiopulmonary bypass or extubation; continued treatment may pose a risk to the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: ERAS	Other: Preoperative Strategies; Patient Education Preoperative Oral Carbohydrate Loading Nutritional Optimization Glycemic Control Anemia Correction Preoperative Hair Removal; Other: Intraoperative Strategies; Anesthetic Technique (Multimodal Analgesia) Antibiotics Glycemic Control Blood Transfusion Blood Conservation Optimization of Hemodynamics Protective Lung Ventilation Strategy Optimization of Anesthetic Depth Optimization of CPB Management; Other: Postoperative Strategies; Postoperative Analgesia Temperature Management Renal Protection Glycemic Control Early Extubation Early Oral Intake Maintain Drain Patency and Early Removal Early Ambulation Thromboprophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	Within 1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation after surgery		Within 1 week after surgery
Length of ICU stay		Within 1 month after surgery
Overall hospitalization costs		Within 3 months after surgery
Postoperative bowel motility		within 1 month after surgery
Transfusion requirements		within 1 month after surgery
Postoperative acute pain	assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)	within 1 month after surgery
Quality of recovery	assessed using the 15-item Quality of Recovery-15 (QoR-15) scale, with each item scored from 0 (very poor) to 10 (very good), for a total score of 150	within 1 month after surgery
Chronic pain	Diagnostic Criteria of Chronic (postsurgical) Pain; Chronic pain (persistent or recurrent for longer than 3 months) is present.; The pain began or increased in intensity after surgery.; The pain is in an area of preceding surgery.; The pain persisted for at least 3 months after the initiating event.; The pain is not better accounted for by an infection, a malignancy, a pre-existing pain condition or any other alternative	within 6 months after surgery
Patient's subjective comfort	assessed using the Bruggrmann Comfort Scale (BCS)，it is a scoring tool for assessing patient comfort, ranging from 0 (persistent pain) to 4 (pain-free even when coughing)	within 6 months after surgery
Postoperative complications	Including mortality and complications both in-hospital and post-discharge	within 6 months after surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac surgery; ERAS
• Other Study ID Numbers: ERAS in CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No