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

NCT05914103 | Unknown DMC

• 1 other identifier: 2023-1969
• Study Type: interventional
• Target: 3,030
• Locations: 1 country
• Sites: 2

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.

Conditions

Complex Congenital Heart Disease; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• length of hospital stay

  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, assessed up to 30 days

• time to extubation

  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, assessed up to 30 days

• the rate of other complications

  during hospitalization, an average of 1 week, assessed up to 30 days

Study Arms (2)

Intervention

EXPERIMENTAL

Procedure: ERAS

Control

NO INTERVENTION

Interventions

ERAS PROCEDURE

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)

Intervention

Eligibility Criteria

• Age: 28 Days - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 28 days to 6 years
• Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Fuwai Yunnan Cardiovascular Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• The Second People's Hospital of GuangDong Province: collaborator
• Shanghai Children's Medical Center: collaborator

Study Sites (2)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

Fuwai hospital

China, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Dou D, Jia Y, Yuan S, Wang Y, Li Y, Wang H, Ding J, Wu X, Bie D, Liu Q, An R, Yan H, Yan F. The protocol of Enhanced Recovery After Cardiac Surgery (ERACS) in congenital heart disease: a stepped wedge cluster randomized trial. BMC Pediatr. 2024 Jan 5;24(1):22. doi: 10.1186/s12887-023-04422-2.

  PMID: 38183047 DERIVED

Study Officials

• Yan

  Fuxia hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuxia Yan

CONTACT

13641158173; yanfuxia@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)