Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Major complications
研究概览
简要总结
Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.
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
- None
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed written consent signed by legal representative (parent or guardian)
- •radical correction of congenital heart defect(s)
- •use of cardiopulmonary bypass
- •vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.
排除标准
- •confirmed intranatal infection;
- •gestational age < 37 weeks;
- •inotropic support prior to surgery;
- •acute renal or hepatic failure prior to surgery;
- •participation in conflicting randomised controlled studies.
研究组 & 干预措施
Goal directed therapy
Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals
干预措施: Goal directed therapy (Procedure)
Control
Conventional therapy
干预措施: Control (Other)
结局指标
主要结局
Major complications
时间窗: Through study completion, an average of 30 days
Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis
次要结局
未报告次要终点