NCT01320878

Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	iloprost nebuliser solution	iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
DRUG	iloprost nebuliser solution	iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
DRUG	distilled water	distilled water 2 ml per session

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2011-03-23
• Last updated: 2012-06-18

Locations

1 site across 1 country: China