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

Fudan University

Status: Invitation-only

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

Treatments: Procedure: Conventional Treatment group; Procedure: "goal-directed" treatment strategy based on oxygen supply and consumption balance

Study type: Interventional

Funder types: Other

Identifiers

NCT06747546

202501011231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 week to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Treatment group

Experimental group

Experimental group

Description:

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.

Treatment:

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