Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Adverse events in early postoperative period
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.
详细描述
Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)
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 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2)
- •coarctation of aorta with septal defects
排除标准
- •coarctation with mild aortic arch hypoplasia (distal aortic arch z-score > -2)
- •complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)
- •univentricular and duct-dependent heart defects
- •aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score < -2.0)
- •left ventricular dysfunction (left ventricle ejection fraction < 60%)
- •congenital renal or central nervous system anomalies
- •related infectious diseases
- •prematurity (gestational age < 37 weeks)
研究组 & 干预措施
Deep hypothermic arrest
Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest
干预措施: Surgical repair of coarctation of aorta (Procedure)
Selective antegrade cerebral perfusion
Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion
干预措施: Surgical repair of coarctation of aorta (Procedure)
Double arterial cannulation
Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation
干预措施: Surgical repair of coarctation of aorta (Procedure)
结局指标
主要结局
Adverse events in early postoperative period
时间窗: 30 days after surgery
Number of participants with adverse events that are related to treatment (including hospital mortality, renal injury (pRIFLE criteria), neurological complications (confirmed by CT or MRI) )
次要结局
- Temperature of cooling (C)(intraoperatively)
- Duration of CPB (min)(intraoperatively)
- Degree of inotropic support (inotropic score)(through ICU stay, an average of 3 weeks)
- Intraoperative blood loss (ml)(intraoperatively)