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

Y

Yan Fuxia

Status

Not yet enrolling

Conditions

Cardiac Surgery
Enhanced Recovery After Surgery

Treatments

Procedure: ERAS

Study type

Interventional

Funder types

Other

Identifiers

NCT05914090
2023--1968

Details and patient eligibility

About

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.

Enrollment

3,600 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

3,600 participants in 2 patient groups

Intervention group
Experimental group
Treatment:
Procedure: ERAS
Control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Yan/Principle investigator

Data sourced from clinicaltrials.gov

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