Pulmonary Hypertension Clinical Trial
Official title:
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)
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.
Primary objectives:
1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular
repair for CHD.
2. To verify the benefits of iloprost inhaled in improving the hemodynamics after
biventricular repair for CHD.
Secondary objectives:
1. 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.
2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC
and to decrease the use of ECMO/VAD.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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