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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pulmonary Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01310751

SJTUMS-200903

Details and patient eligibility

About

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

Full description

Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.

Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.

Enrollment: 36 patients

Sex: All

Ages: 9 days to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

iloprost nebuliser solusion

Experimental group

Description:

50 ng/kg/min

Treatment:

Drug: iloprost nebuliser solusion

distilled water

Placebo Comparator group

Description:

2ml

Treatment:

Drug: distilled water