NCT00235521

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

Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost (Ventavis®) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	aerosolized iloprost

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-10-10
• Last updated: 2012-12-12

Locations

1 site across 1 country: Germany