The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult

Sponsor
Yan Fuxia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05914090
Collaborator
(none)
3,600
2
2
18
1800
100

Study Details

Study Description

Brief Summary

Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ERAS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3600 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Procedure: ERAS
Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Composite outcomes [during hospitalization, an average of 1 week, assessed up to 30 days]

    The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI).

Secondary Outcome Measures

  1. the quality of recovery score (QoR)-15 after surgery [At 24 hour after surgery]

  2. length of hospital stay [From the date of admission until the date of discharging, assessed up to 30 days]

    From the date of admission until the date of discharging

  3. the duration of intensive care unit (ICU) stay [Time from ICU admission to ICU discharge, assessed up to 30 days]

    Time from ICU admission to ICU discharge

  4. time to extubation [The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days]

    The time from the end of operation to the removal of tracheal intubation

  5. time to drainage removal [The time from the end of operation to the removal of drainage tube, assessed up to 30 days]

    The time from the end of operation to the removal of drainage tube

  6. the rate of other complications [during hospitalization, an average of 1 week, assessed up to 30 days]

    The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on

  7. the rate of reintubation for any cause [during hospitalization, an average of 1 week, assessed up to 30 days]

    The rate of reintubation for any cause

  8. cumulative opioid dosage [during hospitalization, an average of 1 week, assessed up to 30 days]

    Total perioperative consumption of opioid analgesics

  9. overall medical costs [during hospitalization, an average of 1 week, assessed up to 30 days]

    Total cost of patients during hospitalization

  10. satisfaction score [the day before discharge, assessed up to 30 days]

    A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory)

  11. the cumulative incidence of death from any cause within 30 days and 1 year [within 30 days and 1 year]

    the cumulative incidence of death from any cause within 30 days and 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged 18 to 80 years

  • Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:
  • American Society of Anesthesiologists (ASA) class is above class V

  • Patients with cardiac assist device or mechanical ventilation

  • The ejection fraction of patients is less than 30%

  • Patients with morbid obesity

  • Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS)

  • Patients with severe pulmonary disease, including severe chronic obstructive pulmonary disease (COPD) or respiratory failure

  • Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy

  • Patients with long-term opioid or sedative utilization

  • Patients with a history of alcohol or cigarette abuse

  • Patients with long-term hormone therapy

  • An international normalized ratio > 2.0

  • Patients with severe malnutrition

  • Mental or legal disability

  • Current enrollment in another clinical trial

  • Patients' refusal or low adherence

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fuwai hospital China Beijing China 100037
2 Fuwai hospital China Beijing China 100037

Sponsors and Collaborators

  • Yan Fuxia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yan Fuxia, principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT05914090
Other Study ID Numbers:
  • 2023--1968
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 22, 2023