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

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: iloprost nebuliser solution; Drug: distilled water

• Registration Number: NCT01320878
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-15
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iloprost high dose group	iloprost nebuliser solution	iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
iloprost low dose group	iloprost nebuliser solution	iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
placebo group	distilled water	distilled water 2 ml per session

Primary Outcome Measures

Name	Time	Method
all cause pulmonary artery pressure	one year

Secondary Outcome Measures

Name	Time	Method
central venous pressure	one year
blood pressure	one year
cardiac index	one year
pulmonary vascular resistance	one year
mortality	one year

Trial Locations

Locations (1)

Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center; 🇨🇳 Shanghai, China