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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01320878

SJTUMS-10-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 3 patient groups, including a placebo group

iloprost low dose group

Active Comparator group

Description:

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

Treatment:

Drug: iloprost nebuliser solution

Drug: iloprost nebuliser solution

iloprost high dose group

Active Comparator group

Description:

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

Treatment:

Drug: iloprost nebuliser solution

Drug: iloprost nebuliser solution

placebo group

Placebo Comparator group

Description:

distilled water 2 ml per session

Treatment:

Drug: distilled water