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

NCT06747546 | Enrolling By Invitation

• 1 other identifier: 202501011231
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of death

  1 month after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

"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.

Experimental group

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.

Control group

Eligibility Criteria

• Age: 1 Week - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Body weight \> 2.5kg;
• Preoperative oxygen saturation \>80%;
• Biventricular radical surgery with cardiopulmonary bypass.

You may not qualify if:

• \. Complicated with functional single ventricle and atrial isomerism;
• Complicated with liver, kidney, lung, brain and other vital organ diseases;
• History of rescue before operation;
• Palliative surgery;
• Residual deformities that significantly affected hemodynamics after operation;
• Guardians did not provide the bundle of informed consent.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Minhang, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ping Ya Mi

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)