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

Official title

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

Overview

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.

Interventions

• 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 significant
• 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.

Primary outcome measures

• Number of participants with low cardiac output syndrome [Time frame: 72 hours after surgery]

Secondary outcome measures (1)

• Number of death [Time frame: 1 month after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Children's Hospital of Fudan University — Minhang

Identifiers

NCT: NCT06747546 · 202501011231

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗