🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06747546
Enrolling by invitation Not applicable

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

NCT06747546 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Not applicable
Started
2025-01-01
Last updated
2026-03-16

Condition(s) studied

Congenital Heart Disease (CHD)Cardiopulmonary BypassChildrenOxygen DeliveryOxygen ConsumptionOxygen SaturationGoal-directed Therapy

Investigational drug(s) / intervention(s)

"goal-directed" treatment strategy based on oxygen supply and consumption balanceConventional Treatment group

"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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
1 Week
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Minhang Shanghai Municipality

More Children's Hospital of Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06747546 on ClinicalTrials.gov ↗ ← All trials in China