The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

Not Applicable

Completed

• Conditions: ERAS
• Interventions: Other: Nutrition; Other: Control Blood Glucose; Drug: Fasting; Behavioral: Smoking and Alcohol; Other: Control Anemia; Other: Blood Transfusion; Other: GDFT; Other: Remove the tracheal tube; Behavioral: Eating and Drinking; Other: Prevent Thrombosis

• Registration Number: NCT04642274
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-21
• Study First Posted: 2020-11-24
• Study Start: 2021-07-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-11-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS	Nutrition	-
ERAS	Control Blood Glucose	-
ERAS	Fasting	-
ERAS	Smoking and Alcohol	-
ERAS	Control Anemia	-
ERAS	Blood Transfusion	-
ERAS	GDFT	-
ERAS	Remove the tracheal tube	-
ERAS	Eating and Drinking	-
ERAS	Prevent Thrombosis	-

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Within 1 month after surgery

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	Within 1 month after surgery
Duration of mechanical ventilation after surgery	Within 1 week after surgery
Postoperative bowel motility	within 1 month after surgery
Overall hospitalization costs	Within 3 months after surgery
Transfusion requirements	within 1 month after surgery
Postoperative acute pain	within 1 month after surgery	assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Quality of recovery	within 1 month after surgery	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
Chronic pain	within 6 months after surgery	Diagnostic Criteria of Chronic (postsurgical) Pain; 1. Chronic pain (persistent or recurrent for longer than 3 months) is present.; 2. The pain began or increased in intensity after surgery.; 3. The pain is in an area of preceding surgery.; 4. The pain persisted for at least 3 months after the initiating event.; 5. The pain is not better accounted for by an infection, a malignancy, a pre-existing pain condition or any other alternative
Patient's subjective comfort	within 6 months after surgery	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)
Postoperative complications	within 6 months after surgery	Including mortality and complications both in-hospital and post-discharge

Trial Locations

Locations (4)

The First Affiliated Hospital of AnHui Medical University; 🇨🇳 Hefei, Anhui, China

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China