Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery

Not Applicable

• Conditions: Congenital Heart Disease (CHD); Cardiopulmonary Bypass; Oxygen Delivery; Children; Oxygen Consumption; Oxygen Saturation; Goal-directed Therapy

• Registration Number: NCT06747546
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

The objective is to investigate a goal-oriented postoperative circulation management strategy centered on "oxygen metabolism balance". This strategy is independent of the absolute metrics of oxygen supply and consumption, and aims to enhance oxygen consumption and uptake within the critical "golden 8 hours" following pediatric cardiopulmonary bypass, thereby preventing severe hypotension, cardiopulmonary arrest, and other adverse events.

Detailed Description

This study firstly offered a specialized treatment strategy for children, particularly those who have undergone cardiopulmonary bypass surgery, that uses tailored parallel control and is independent of absolute oxygen supply and consumption characteristics.In addition, this study seeks to investigate the correlation between oxygen supply and consumption following pediatric cardiopulmonary bypass surgery and to assess the clinical utility of a goal-directed strategy concerning cardiac function recovery (ICON, echocardiography, myocardial markers) and outcomes (incidence of low cardiac output, duration of endotracheal intubation, length of CCU stay, and mortality). This strategy is of great significance to improve the surgical outcomes and prognoses for children.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1.Body weight > 2.5kg;
• 2.Preoperative oxygen saturation >80%;
• 3.Biventricular radical surgery with cardiopulmonary bypass.

Exclusion Criteria

• 1. Complicated with functional single ventricle and atrial isomerism;
• 2.Complicated with liver, kidney, lung, brain and other vital organ diseases;
• 3.History of rescue before operation;
• 4.Palliative surgery;
• 5.Residual deformities that significantly affected hemodynamics after operation;
• 6.Guardians did not provide the bundle of informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with low cardiac output syndrome	72 hours after surgery	Low Cardiac Output Syndrome (LCOS) is a pathological state of cardiac dysfunction, which is usually manifested as a significant decrease in cardiac output (the amount of blood pumped by the heart per minute), leading to hypoperfusion of systemic organs.Low cardiac output was defined as cardiac index \<2.0L/(min.m2).

Secondary Outcome Measures

Name	Time	Method
Number of death	1 month after surgery

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Minhang, Shanghai, China