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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Iloprost; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

Before corrective procedure for CHD, two of bellow ten criteria should be met:

• Decreased respiratory infection & decreased exercise tolerance

• Pulse SaO2 < 93% in left-right shunt CHD case (in room air)

• EKG: right ventricular hypertrophy, right atrial dilatation

• Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement

• Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt

• Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels

• Pp/Ps > 0.75

• Qp/Qs <1.5

• PVR > 9WU/m2

• Rp/Rs > 0.5

Exclusion Criteria:

• a body weight of < 2 kg,

• prematurity (birth 36 weeks postconceptual age)

• renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)

• PLT < 50,000*109/L and obvious bleeding

• LCOS or hypotension on arrival to the intensive care unit

After corrective procedure for CHD:

• deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation

• severe arrhythmia led to low cardiac output