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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: distilled water; Drug: iloprost nebuliser solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01598441

SCMCIRB-201127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 7 days to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups, including a placebo group

iloprost

Experimental group

Description:

Iloprost nebuliser solution 500 ng/kg inhaled

Treatment:

Drug: iloprost nebuliser solution

distilled water

Placebo Comparator group

Description:

aerosolized distilled water 1-2 ml

Treatment:

Drug: distilled water