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

Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After Congenital Heart Disease Surgery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Children; Cardiopulmonary Bypass; Oxygen Consumption; Congenital Heart Disease (CHD); Goal-directed Therapy; Oxygen Saturation; Oxygen Delivery
• Intervention / Treatment: Procedure: Conventional Treatment group; Procedure: "goal-directed" treatment strategy based on oxygen supply and consumption balance

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Minhang, Shanghai Municipality, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Treatment is routinely adjusted according to the changes of blood pressure and other monitoring indicators.Ventilation assistance is modified to sustain arterial oxygen partial pressure and oxygen saturation levels. Administer suitable fluid infusion to stabilize central venous pressure and maintain preload; Concurrent use of vasoactive agents to sustain heart rate and blood pressure; Effective diuresis can enhance urine production and decrease cardiac afterload. Blood transfusion is employed to enhance coagulation function and sustain adequate hematocrit levels.	Procedure: Conventional Treatment group; Ventilation support is adjusted to maintain arterial oxygen partial pressure and oxygen saturation. Appropriate fluid infusion to stabilize central venous pressure and ensure preload; Combined use of vasoactive drugs to maintain heart rate and blood pressure; Appropriate diuresis can improve urine output and reduce cardiac afterload. Blood transfusion is used to improve coagulation function and maintain appropriate hematocrit.
Experimental: Experimental group; On the basis of routine treatment in the control group, PICCO is used to evaluate cardiac index (CI), bedside echocardiography is used to evaluate cardiac function, NIRS is used to measure rScO2, rSrO2 and rSsO2, and arterial and central venous blood gas are measured at the same time after operation. DO2, VO2, ERO2, and Pv-aCO2 gap are calculated according to the formula. The oxygen extraction rate immediately after CPB is set as E1, the oxygen extraction rate at 4 hours after surgery is E2, and the oxygen extraction rate at 8 hours after surgery is E3.A "goal-directed" treatment strategy based on oxygen supply and consumption balance is defined as: Combined with the value of E2 at 4 hours after CPB, the increasing VO2 after CPB is compensated by increasing DO2 to different degrees. The goal of E3 not increasing significantly compared with E1 is achieved at 8 hours after CPB, and the severity of low cardiac output is finally reduced within the "golden 8 hours" after CPB.	Procedure: "goal-directed" treatment strategy based on oxygen supply and consumption balance; The oxygen extraction rate immediately after CPB is set as E1, the oxygen extraction rate at 4 hours after surgery is E2, and the oxygen extraction rate at 8 hours after surgery is E3. A "goal-directed" treatment strategy based on oxygen supply and consumption balance is defined as: Combined with the value of E2 at 4 hours after CPB, the increasing oxygen consumption (VO2) after CPB is compensated by increasing oxygen delivery (DO2) to different degrees. The goal of E3 not increasing significantly compared with E1 is achieved at 8 hours after CPB, and the severity of low cardiac output is finally reduced within the "golden 8 hours" after CPB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with low cardiac output syndrome	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).	72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of death	1 month after surgery

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Ping Ya Mi, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 202501011231

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