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

Phase 3

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: iloprost nebuliser solution; Drug: distilled water

• Registration Number: NCT01598441
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2012-05-06
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Study Start: 2012-06
• Status Verified: 2016-01
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• CHD children who have associated PH risk factors and have accepted biventricular repair
• Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)

Exclusion Criteria

• severe mitral stenosis
• obstructive drainage of pulmonary veins
• platelet count < 50,000,000,000/L & obvious bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iloprost	iloprost nebuliser solution	Iloprost nebuliser solution 500 ng/kg inhaled
distilled water	distilled water	aerosolized distilled water 1-2 ml

Primary Outcome Measures

Name	Time	Method
The total incidence of RPH, PHC or death	within 48 hours after surgery	The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or; * PHC at any time; or; * death

Secondary Outcome Measures

Name	Time	Method
Change from base line of pulmonary hemodynamic measurements	within 48 hours after surgery	* Pp/Ps; * NYHA class function; * SvO2; * PAO2

Trial Locations

Locations (3)

Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center; 🇨🇳 Shanghai, China

Wuhan Asia Hear Hospital; 🇨🇳 Wuhan, Hubei, China

Guangzhou Children's Hospital; 🇨🇳 Guangzhou, Guangdong, China