Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 试验地点
- 4
- 主要终点
- Major complications
研究概览
简要总结
Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective repair of congenital heart defects under cardiopulmonary bypass
排除标准
- •absence of written informed consent signed by parent or guardian;
- •hypoplastic left heart syndrome;
- •participation in conflicting randomised studies;
- •emergency surgery;
- •inotropic support prior to surgery;
- •mechanical ventilation prior to surgery;
- •bacterial, viral or fungal infection in the preceding 30 days;
- •gestational age less that 37 weeks;
- •perinatal central nervous system damage.
研究组 & 干预措施
Experimental
Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia
干预措施: Dexamethasone (Drug)
Control
0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
Major complications
时间窗: 30 days after surgery
Composite of all-cause death, myocardial infarction, need for extracorporeal membrane oxygenation implantation, cardiac arrest, acute renal failure (stage "injury" or higher according to pRIFLE scale), prolonged mechanical ventilation (\> 24 hours), stroke, seizure, coma.
次要结局
未报告次要终点