Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
|Study Design:||Allocation: Randomized
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235521
|University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Matthias Gorenflo, MD, PhD||Heidelberg University|