Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- The total incidence of RPH, PHC or death
研究概览
简要总结
This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
详细描述
Primary objectives:
- To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
- To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.
Secondary objectives:
- To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
- To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.
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
- 7 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHD children who have associated PH risk factors and have accepted biventricular repair
- •Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)
排除标准
- •severe mitral stenosis
- •obstructive drainage of pulmonary veins
- •platelet count < 50,000,000,000/L & obvious bleeding
研究组 & 干预措施
iloprost
Iloprost nebuliser solution 500 ng/kg inhaled
干预措施: iloprost nebuliser solution (Drug)
distilled water
aerosolized distilled water 1-2 ml
干预措施: distilled water (Drug)
结局指标
主要结局
The total incidence of RPH, PHC or death
时间窗: within 48 hours after surgery
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or * PHC at any time; or * death
次要结局
- Change from base line of pulmonary hemodynamic measurements(within 48 hours after surgery)
研究者
Xu Zhuoming
Director of ICU, Department of thoracic and cardiovascular surgery, Shanghai Children's Medical Center
Shanghai Jiao Tong University School of Medicine