Clinical trial NCT05914090: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult
Official title: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Enhanced Recovery After Surgery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite outcomes
timeFrame: during hospitalization, an average of 1 week, assessed up to 30 days
Secondary outcomes:
measure: the quality of recovery score (QoR)-15 after surgery
timeFrame: At 24 hour after surgery
measure: length of hospital stay
timeFrame: From the date of admission until the date of discharging, assessed up to 30 days
measure: the duration of intensive care unit (ICU) stay
timeFrame: Time from ICU admission to ICU discharge, assessed up to 30 days
measure: time to extubation
timeFrame: The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
measure: time to drainage removal
timeFrame: The time from the end of operation to the removal of drainage tube, assessed up to 30 days
measure: the rate of other complications
timeFrame: during hospitalization, an average of 1 week, assessed up to 30 days
measure: the rate of reintubation for any cause
timeFrame: during hospitalization, an average of 1 week, assessed up to 30 days
measure: cumulative opioid dosage
timeFrame: during hospitalization, an average of 1 week, assessed up to 30 days
measure: overall medical costs
timeFrame: during hospitalization, an average of 1 week, assessed up to 30 days
measure: satisfaction score
timeFrame: the day before discharge, assessed up to 30 days
measure: the outcomes of long-term prognosis by telephone follow-up
timeFrame: within 30 days, 3 months, and 1 year
Other outcomes:
Locations:
city: China
country: China
facility: Fuwai hospital
state: Beijing
city: China
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References: