The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

July 29, 2025 updated by: Shanghai Zhongshan Hospital
The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Within 1 month after surgery
Within 1 month after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation after surgery
Time Frame: Within 1 week after surgery
Within 1 week after surgery
Length of ICU stay
Time Frame: Within 1 month after surgery
Within 1 month after surgery
Overall hospitalization costs
Time Frame: Within 3 months after surgery
Within 3 months after surgery
Postoperative bowel motility
Time Frame: within 1 month after surgery
within 1 month after surgery
Transfusion requirements
Time Frame: within 1 month after surgery
within 1 month after surgery
Postoperative acute pain
Time Frame: within 1 month after surgery
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
Time Frame: 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
within 1 month after surgery
Chronic pain
Time Frame: 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
within 6 months after surgery
Patient's subjective comfort
Time Frame: 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)
within 6 months after surgery
Postoperative complications
Time Frame: within 6 months after surgery
Including mortality and complications both in-hospital and post-discharge
within 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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