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NCT Number: NCT06747546

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

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Key information

Conditions

Congenital Heart Disease (CHD) Cardiopulmonary Bypass Cardiovascular Abnormalities Cardiovascular Diseases Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Goal-directed Therapy Heart Defects, Congenital Heart Diseases Oxygen Consumption Oxygen Delivery Oxygen Saturation

Age range

1 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Minhang, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"goal-directed" treatment strategy based on oxygen supply and consumption balance

Procedure

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.

Conventional Treatment group

Procedure

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.

Primary outcomes

  1. Number of participants with low cardiac output syndrome

    Time frame: 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 outcomes

  1. Number of death

    Time frame: 1 month after surgery

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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