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The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

Fudan University logo

Fudan University

Status

Completed

Conditions

ERAS

Treatments

Other: Postoperative Strategies
Other: Preoperative Strategies
Other: Intraoperative Strategies

Study type

Interventional

Funder types

Other

Identifiers

NCT04642274
ERAS in CS

Details and patient eligibility

About

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

Full 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.

Enrollment

400 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups

ERAS
Experimental group
Treatment:
Other: Intraoperative Strategies
Other: Preoperative Strategies
Other: Postoperative Strategies
Control
No Intervention group

Trial contacts and locations

4

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Central trial contact

Guo Kefang, MD

Data sourced from clinicaltrials.gov

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