Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

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

1. Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)

2. EKG: right ventricular hypertrophy, right atrial dilatation

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

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

5. Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels

6. Pp/Ps greater than 0.75

7. Qp/Qs smaller than 1.5

8. PVR grater than 9 Wood Unit/m2

9. Rp/Rs graeter than 0.5

Exclusion Criteria:

After corrective procedure for CHD:

1. Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation

2. Severe arrhythmia led to low cardiac output

3. PLT smaller than 50,000*109/L and obvious bleeding