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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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iloprost low dose group

iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days

Group Type ACTIVE_COMPARATOR

iloprost nebuliser solution

Intervention Type DRUG

iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days

iloprost high dose group

iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days

Group Type ACTIVE_COMPARATOR

iloprost nebuliser solution

Intervention Type DRUG

iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days

placebo group

distilled water 2 ml per session

Group Type PLACEBO_COMPARATOR

distilled water

Intervention Type DRUG

distilled water 2 ml per session

Interventions

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iloprost nebuliser solution

iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days

Intervention Type DRUG

iloprost nebuliser solution

iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days

Intervention Type DRUG

distilled water

distilled water 2 ml per session

Intervention Type DRUG

Other Intervention Names

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Ventavis Ventavis Treeful

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No