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

Study Overview
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Brief Summary
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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.

Detailed Description
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Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

Official Title
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A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: iloprost nebuliser solution
* Drug: iloprost nebuliser solution
* Drug: distilled water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iloprost low dose group<br>iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days | Drug: iloprost nebuliser solution<br>* iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days<br>* Other names: Ventavis;|
| Active Comparator: iloprost high dose group<br>iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days | Drug: iloprost nebuliser solution<br>* iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days<br>* Other names: Ventavis;|
| Placebo Comparator: placebo group<br>distilled water 2 ml per session | Drug: distilled water<br>* distilled water 2 ml per session<br>* Other names: Treeful;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause pulmonary artery pressure |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central venous pressure |  | one year | 
| blood pressure |  | one year | 
| cardiac index |  | one year | 
| pulmonary vascular resistance |  | one year | 
| mortality |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary hypertension