This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
Primary objectives: 1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD. 2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD. Secondary objectives: 1. To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass. 2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
1-2 ml aerosolized distilled water inhalation per session
Guangzhou Children's Hospital
Guangzhou, Guangdong, China
Wuhan Asia Hear Hospital
Wuhan, Hubei, China
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Shanghai, China
The total incidence of RPH, PHC or death
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or * PHC at any time; or * death
Time frame: within 48 hours after surgery
Change from base line of pulmonary hemodynamic measurements
* Pp/Ps * NYHA class function * SvO2 * PAO2
Time frame: within 48 hours after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.