The Impact of ERAS Program in Cardiac Surgery on Patient... | NCT04642274

Studies
The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

NCT04642274

Sponsor

Shanghai Zhongshan Hospital

Status

Completed

Last Update Posted

Aug 3, 2025Actual

Enrollment

400Actual

Phase

Not Applicable

Conditions

ERAS

Interventions

Preoperative Strategies
Intraoperative Strategies
Postoperative Strategies

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Nov 17, 2020

First Submission Date that Met QC Criteria

Nov 21, 2020

First Posted Date

Nov 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Aug 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ERAS	Experimental		Other: Preoperative Strategies Other: Intraoperative Strategies Other: Postoperative Strategies
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative Strategies	Other	Patient Education Preoperative Oral Carbohydrate Loading Nutritional Optimization Glycemic Control Anemia Correction Preoperative Hair Removal	ERAS

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

Measure	Description	Time Frame
Length of ICU stay		Within 1 month after surgery
Duration of mechanical ventilation after surgery		Within 1 week after surgery
Postoperative bowel motility

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of AnHui Medical University		Hefei	Anhui	230022	China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine