Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After Congenital Heart Disease Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants with low cardiac output syndrome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Week 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Body weight > 2.5kg;
- •2.Preoperative oxygen saturation >80%;
- •3.Biventricular radical surgery with cardiopulmonary bypass.
排除标准
- •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.
研究组 & 干预措施
Control group
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.
干预措施: Conventional Treatment group (Procedure)
Experimental group
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.
干预措施: "goal-directed" treatment strategy based on oxygen supply and consumption balance (Procedure)
结局指标
主要结局
Number of participants with low cardiac output syndrome
时间窗: 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).
次要结局
- Number of death(1 month after surgery)