Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost (Ventavis®) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery|
- Number of pulmonary hypertensive crises (major and/or minor)
- Treatment with aerosolized ILO is equally effective as iNO in reducing the pulmonary artery pressure (PAP) within the first 72 hours after cardiopulmonary bypass surgery (CPB)
- Patients treated with aerosolized ILO can be weaned earlier from mechanical ventilation than patients on iNO treatment
- Patients treated with aerosolized ILO show the same in-hospital mortality as patients treated with iNO
|Study Start Date:||May 2005|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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
- 20 patients: inhaled nitric oxide (iNO) - group;
- 20 patients: aerosolized iloprost (ILO) -group
- 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
|University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Matthias Gorenflo, MD, PhD||University of Heidelberg|