Clinical trial NCT05914103: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease
Official title: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complex Congenital Heart Disease
Enhanced Recovery After Surgery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Fuwai Yunnan Cardiovascular Hospital
name: Beijing Anzhen Hospital
name: The Second People's Hospital of GuangDong Province
name: Shanghai Children's Medical Center
First posted: 2023-06-22
Enrollment: 3030
Sex: ALL
Minimum age (years): 28
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme.

Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, 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 (MACE 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, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores 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 28 days to 6 years
* Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).

Exclusion Criteria:

* The risk adjustment for congenital heart surgery (RACHS) is above class 5
* Patients with cardiac assist device, mechanical ventilation or the history of asphyxia
* Patients with pulmonary disease, including respiratory tract infections and asthma
* 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
* Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome
* Current enrollment in another clinical trial
* Guardian's 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: 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 cumulative incidence of death from any cause within 30 days and 1 year
timeFrame: within 30 days and 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
city: China
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Fuxia hospital
name: Yan
role: PRINCIPAL_INVESTIGATOR
References: