Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- The primary end point is a composite variable
研究概览
简要总结
The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.
详细描述
PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After Fontan procedure, the criteria should be met
- •mPAP greater than 15 mmHg
- •TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)
排除标准
- •After Fontan surgery :
- •Severe arrhythmia led to low cardiac output
- •Platelets smaller than 50,000*109/L and obvious bleeding
研究组 & 干预措施
Remodulin Injection
Drug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours
干预措施: Remodulin (Drug)
Distilled water group
Drug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours
干预措施: distilled water (Drug)
结局指标
主要结局
The primary end point is a composite variable
时间窗: the first 48 hours after Remodulin used
consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance
次要结局
- Change from base line of pulmonary hemodynamic measurements(baseline and 48 hours)
研究者
Xu Zhuoming
chief cadiologist,Director of Cardiac intensive Care Unit
Shanghai Jiao Tong University School of Medicine