Status:
COMPLETED
Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
Lead Sponsor:
Heidelberg University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
Up to 2 years
Phase:
NA
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...
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, German...
Eligibility Criteria
Inclusion
- Informed consent by parents or legal representatives
- Age: Infants older than 4 weeks of age and children less than 1½ years of age.
- Presence of a left-to-right shunt with increased pulmonary blood flow. The specific defects that will be present are:
- Aortopulmonary (AP) - Window
- Atrioventricular septal defect (AVSD)
- Double outlet right ventricle (DORV)
- Total anomalous pulmonary venous drainage (TAPVD)
- Truncus arteriosus
- Ventricular septal defect (VSD)
- Presence of postoperative PH immediately after intracardiac repair:
- Patients will be enrolled if mean PAP after intracardiac repair exceeds 25 mmHg after weaning from CPB.
Exclusion
- Specific cardiac defects:
- Atrial septal defect (ASD)
- Cyanotic congenital heart disease
- Univentricular atrio-ventricular - connexion
- Valvular or subvalvular pulmonary or aortic stenosis
- Specific circumstances:
- Emergency cardiac surgery
- Children presenting with infection after cardiac surgery
- Infants on extracorporeal membrane oxygenation (ECMO) before cardiac surgery
- Infants/children treated with epoprostenol
- Concomitant diseases:
- Systemic arterial hypertension
- Renal failure
- Diabetes mellitus
- Known bleeding disorders (known disorders of blood coagulation and hemostasis)
- Infection during the first 24 hours after cardiac surgery
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00235521
Start Date
May 1 2005
End Date
October 1 2008
Last Update
December 12 2012
Active Locations (1)
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1
University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology
Heidelberg, Germany, 69120