The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

NCT ID: NCT04642274

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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ERAS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ERAS

Group Type EXPERIMENTAL

Preoperative Strategies

Intervention Type OTHER

Patient Education Preoperative Oral Carbohydrate Loading Nutritional Optimization Glycemic Control Anemia Correction Preoperative Hair Removal

Intraoperative Strategies

Intervention Type OTHER

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

Postoperative Strategies

Intervention Type OTHER

Postoperative Analgesia Temperature Management Renal Protection Glycemic Control Early Extubation Early Oral Intake Maintain Drain Patency and Early Removal Early Ambulation Thromboprophylaxis

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative Strategies

Patient Education Preoperative Oral Carbohydrate Loading Nutritional Optimization Glycemic Control Anemia Correction Preoperative Hair Removal

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of AnHui Medical University

Hefei, Anhui, China

Site Status

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ERAS in CS

Identifier Type: -

Identifier Source: org_study_id

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