The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease

Enhanced Recovery After Surgery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914103
• Other study ID #: 2023-1969
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Fuxia Yan
• Phone: 13641158173
• Email: yanfuxia[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3030
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Congenital Heart Disease
• Enhanced Recovery After Surgery
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• ERAS
The primary endpoint is the rate of composite outcomes. The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing
China	Fuwai hospital	China	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Anzhen Hospital, Fuwai Yunnan Cardiovascular Hospital, Guangdong People's Hospital, Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcomes	The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	length of hospital stay	From the date of admission until the date of discharging	From the date of admission until the date of discharging, assessed up to 30 days
Secondary	the duration of intensive care unit (ICU) stay	Time from ICU admission to ICU discharge	Time from ICU admission to ICU discharge, assessed up to 30 days
Secondary	time to extubation	The time from the end of operation to the removal of tracheal intubation	The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
Secondary	time to drainage removal	The time from the end of operation to the removal of drainage tube	The time from the end of operation to the removal of drainage tube, assessed up to 30 days
Secondary	the rate of other complications	The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	the rate of reintubation for any cause	The rate of reintubation for any cause	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	cumulative opioid dosage	Total perioperative consumption of opioid analgesics	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	overall medical costs	Total cost of patients during hospitalization	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	Satisfaction score	A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory)	the day before discharge, assessed up to 30 days
Secondary	the cumulative incidence of death from any cause within 30 days and 1 year	the cumulative incidence of death from any cause within 30 days and 1 year	within 30 days and 1 year