A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- all cause pulmonary artery pressure
研究概览
简要总结
The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.
详细描述
Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before corrective procedure for CHD, two of bellow ten criteria should be met:
- •Decreased respiratory infection & decreased exercise tolerance
- •Pulse SaO2 < 93% in left-right shunt CHD case (in room air)
- •EKG: right ventricular hypertrophy, right atrial dilatation
- •Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
- •Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
- •Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels
- •Pp/Ps > 0.75
- •Qp/Qs <1.5
- •PVR > 9WU/m2
- •Rp/Rs > 0.5
排除标准
- •a body weight of < 2 kg,
- •prematurity (birth 36 weeks postconceptual age)
- •renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)
- •PLT < 50,000*109/L and obvious bleeding
- •LCOS or hypotension on arrival to the intensive care unit
- •After corrective procedure for CHD:
- •deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
- •severe arrhythmia led to low cardiac output
研究组 & 干预措施
iloprost low dose group
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
干预措施: iloprost nebuliser solution (Drug)
iloprost high dose group
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
干预措施: iloprost nebuliser solution (Drug)
placebo group
distilled water 2 ml per session
干预措施: distilled water (Drug)
结局指标
主要结局
all cause pulmonary artery pressure
时间窗: one year
次要结局
- central venous pressure(one year)
- blood pressure(one year)
- cardiac index(one year)
- pulmonary vascular resistance(one year)
- mortality(one year)
研究者
Xu Zhuoming
Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.
Shanghai Jiao Tong University School of Medicine