NCT01598441

Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 7 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	iloprost nebuliser solution	Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
DRUG	distilled water	1-2 ml aerosolized distilled water inhalation per session

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2012-05-15
• Last updated: 2016-11-22

Locations

3 sites across 1 country: China