NCT04642274

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

November 17, 2020

Last Update Submit

July 29, 2025

Conditions

ERAS

Keywords

ERASCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Within 1 month after surgery

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

ERAS

EXPERIMENTAL
Other: Preoperative StrategiesOther: Intraoperative StrategiesOther: Postoperative Strategies

Control

NO INTERVENTION

Interventions

Preoperative StrategiesOTHER

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

ERAS
Intraoperative StrategiesOTHER

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

ERAS
Postoperative StrategiesOTHER

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

ERAS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First Affiliated Hospital of AnHui Medical University

Hefei, Anhui, 230022, China

Location

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200000, China

Location

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 24, 2020

Study Start

July 1, 2021

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)