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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Enhanced Recovery After Surgery; Complex Congenital Heart Disease
• Intervention / Treatment: Procedure: ERAS

• Study Type: Interventional
• Enrollment (Estimated): 3030
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuxia Yan; Phone Number: 13641158173; Email: yanfuxia@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital
      • Contact: Fuxia Yan, Dr; Phone Number: 13641158173; Email: yanfuxia@sina.com
      • Contact: Dou Dou, Dr; Phone Number: 18810601342; Email: do.1995@163.com
      • Sub-Investigator: Dou
    • China, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
cumulative opioid dosage	Total perioperative consumption of opioid analgesics	during hospitalization, an average of 1 week, assessed up to 30 days
overall medical costs	Total cost of patients during hospitalization	during hospitalization, an average of 1 week, assessed up to 30 days
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
Satisfaction score	A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory)	the day before discharge, assessed up to 30 days

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Shanghai Children's Medical Center; Beijing Anzhen Hospital; Guangdong People's Hospital; Fuwai Yunnan Cardiovascular Hospital
• Investigators: Principal Investigator: Yan, Fuxia hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2023-1969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No