Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235521
Status:
COMPLETED
Last Update Posted:
2012-12-12
First Post:
2005-10-06
Brief Title:
Iloprost-Study Comparison of Nitric Oxide to Iloprost Ventavis for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost Ventavis for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 µgkg 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
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 05 µgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None