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Completed

NCT Number: NCT04642274

The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of AnHui Medical University, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative Strategies

Other

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

Intraoperative Strategies

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

Other

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

Primary outcomes

  1. Length of hospital stay

    Time frame: Within 1 month after surgery

Secondary outcomes

  1. Length of ICU stay

    Time frame: Within 1 month after surgery

  2. Duration of mechanical ventilation after surgery

    Time frame: Within 1 week after surgery

  3. Postoperative bowel motility

    Time frame: within 1 month after surgery

  4. Overall hospitalization costs

    Time frame: Within 3 months after surgery

  5. Transfusion requirements

    Time frame: within 1 month after surgery

  6. 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)

  7. 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

  8. Chronic pain

    Time frame: within 6 months after surgery

    Diagnostic Criteria of Chronic (postsurgical) Pain

    • Chronic pain (persistent or recurrent for longer than 3 months) is present.
    • The pain began or increased in intensity after surgery.
    • The pain is in an area of preceding surgery.
    • The pain persisted for at least 3 months after the initiating event.
    • The pain is not better accounted for by an infection, a malignancy, a pre-existing pain condition or any other alternative
  9. 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)

  10. Postoperative complications

    Time frame: within 6 months after surgery

    Including mortality and complications both in-hospital and post-discharge

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2020
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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