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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Treatments: Iloprost; Nitric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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