Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery

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