Investigators, Study Sites: Single-center trial at the Department of Pediatric Cardiology, Department of Cardiac Surgery and Department of Anesthesiology, University Medical Center, Heidelberg, Germany Exploratory proof of concept study (Investigator initiated trial)~Indication: Postoperative pulmonary hypertension in infants and children undergoing cardiopulmonary bypass surgery for intracardiac repair of left-to-right shunt~Objectives: To compare the efficacy of aerosolized iloprost with inhaled nitric oxide to prevent postoperative pulmonary hypertensive crises~Design: Exploratory, open label, randomized study with parallel-group design;~Duration of observation: 72 hours~Population: Infants older than 4 weeks and children less than 18 months of age presenting with left-to-right shunt and increased pulmonary blood flow. Inclusion will be independent on the presence or absence of preoperative pulmonary hypertension~Sample Size:~20 patients: inhaled nitric oxide (iNO) - group;~20 patients: aerosolized iloprost (ILO) -group~Treatment:~Both groups: controlled ventilation, sedation, analgetics, inotropic substances as required, standardized intensive care treatment.~iNO - group: concentration of iNO at 10 ppm; administered by mechanical ventilation.~ILO - group: aerosolized Iloprost at a dose of 0,5 µg/kg body weight (12x / 24h), administered by ultrasound nebulizer.~Efficacy Parameters: Occurrence of minor or major pulmonary hypertensive crises (PHTC)~Safety Parameters: Arterial blood pressure, oxygen saturation, complete blood count~Statistical Procedures: All analyses in this exploratory trial are descriptive, giving confidence intervals for differences between treatment groups.~Primary analysis variable: Rate of occurrence of major or minor pulmonary hypertensive crises~Secondary variables: Presence of hours of pulmonary hypertension, Duration of mechanical ventilation
Inhaled nitrous oxide (iNO) will be compared to aerosolized iloprost (ILO) in pediatric patients after cardiac surgery with pulmonary hypertension. The hypothesis is that iloprost is more effective in preventing pulmonary hypertensive crises.