Congenital Heart Disease (CHD), Cardiopulmonary Bypass, Children, Oxygen Delivery, Oxygen Consumption, Oxygen Saturation, Goal-directed Therapy
Conditions
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.
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 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.
PROCEDUREConventional 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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with low cardiac output syndrome | 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
| Measure | Time frame |
|---|---|
| Number of death | 1 month after surgery |
Countries
China
Contacts
STUDY_DIRECTORPing Ya Mi
Children's Hospital of Fudan University
Outcome results
None listed