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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320878
• Other study ID #: SJTUMS-10-16
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2011
• Last updated: June 15, 2012
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• iloprost nebuliser solution
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
• iloprost nebuliser solution
iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
• distilled water
distilled water 2 ml per session

Locations

Country	Name	City	State
China	Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Gorenflo M, Gu H, Xu Z. Peri-operative pulmonary hypertension in paediatric patients: current strategies in children with congenital heart disease. Cardiology. 2010;116(1):10-7. doi: 10.1159/000313864. Epub 2010 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause pulmonary artery pressure		one year	No
Secondary	central venous pressure		one year	No
Secondary	blood pressure		one year	No
Secondary	cardiac index		one year	No
Secondary	pulmonary vascular resistance		one year	No
Secondary	mortality		one year	No