Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost (Ventavis®) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of pulmonary hypertensive crises (major and/or minor)
研究概览
简要总结
Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost is more effective in preventing pulmonary hypertensive crises.
详细描述
Investigators, Study Sites: Single-center trial at the Department of Pediatric Cardiology, Department of Cardiac Surgery and Department of Anesthesiology, University Medical Center, Heidelberg, Germany Exploratory proof of concept study (Investigator initiated trial)
Indication: Postoperative pulmonary hypertension in infants and children undergoing cardiopulmonary bypass surgery for intracardiac repair of left-to-right shunt
Objectives: To compare the efficacy of aerosolized iloprost with inhaled nitric oxide to prevent postoperative pulmonary hypertensive crises
Design: Exploratory, open label, randomized study with parallel-group design;
Duration of observation: 72 hours
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 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent by parents or legal representatives
- •Age: Infants older than 4 weeks of age and children less than 1½ years of age.
- •Presence of a left-to-right shunt with increased pulmonary blood flow. The specific defects that will be present are:
- •Aortopulmonary (AP) - Window
- •Atrioventricular septal defect (AVSD)
- •Double outlet right ventricle (DORV)
- •Total anomalous pulmonary venous drainage (TAPVD)
- •Truncus arteriosus
- •Ventricular septal defect (VSD)
- •Presence of postoperative PH immediately after intracardiac repair:
- •Patients will be enrolled if mean PAP after intracardiac repair exceeds 25 mmHg after weaning from CPB.
排除标准
- •Specific cardiac defects:
- •Atrial septal defect (ASD)
- •Cyanotic congenital heart disease
- •Univentricular atrio-ventricular - connexion
- •Valvular or subvalvular pulmonary or aortic stenosis
- •Specific circumstances:
- •Emergency cardiac surgery
- •Children presenting with infection after cardiac surgery
- •Infants on extracorporeal membrane oxygenation (ECMO) before cardiac surgery
- •Infants/children treated with epoprostenol
- •Concomitant diseases:
- •Systemic arterial hypertension
- •Renal failure
- •Diabetes mellitus
- •Known bleeding disorders (known disorders of blood coagulation and hemostasis)
- •Infection during the first 24 hours after cardiac surgery
结局指标
主要结局
Number of pulmonary hypertensive crises (major and/or minor)
次要结局
- Treatment with aerosolized ILO is equally effective as iNO in reducing the pulmonary artery pressure (PAP) within the first 72 hours after cardiopulmonary bypass surgery (CPB)
- Patients treated with aerosolized ILO can be weaned earlier from mechanical ventilation than patients on iNO treatment
- Patients treated with aerosolized ILO show the same in-hospital mortality as patients treated with iNO
研究者
Matthias Gorenflo
Prof. Dr. med.
Heidelberg University