Pulmonary Hypertension
Conditions
Keywords
pulmonary hypertension
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.
Interventions
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
DRUGdistilled water
distilled water 2 ml per session
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause pulmonary artery pressure | one year |
Secondary
| Measure | Time frame |
|---|---|
| central venous pressure | one year |
| blood pressure | one year |
| cardiac index | one year |
| pulmonary vascular resistance | one year |
| mortality | one year |
Countries
China
Outcome results
None listed