Clinical trial NCT01320878: Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Official title: A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: all cause pulmonary artery pressure
timeFrame: one year
Secondary outcomes:
measure: central venous pressure
timeFrame: one year
measure: blood pressure
timeFrame: one year
measure: cardiac index
timeFrame: one year
measure: pulmonary vascular resistance
timeFrame: one year
measure: mortality
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Study officials:
affiliation: Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
name: Zhuo-ming Xu, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.