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

NCT00235521 | Completed DMC

• 1 other identifier: Iloprost-Study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertension; Cardiac Surgery; Children; Pediatric Patients; Iloprost; NO; nitric oxide; Pulmonary hypertension after cardiac surgery in pediatric patients, 0 - 2 years old

Outcome Measures

Primary Outcomes (1)

• Number of pulmonary hypertensive crises (major and/or minor)

Secondary Outcomes (3)

• 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

Interventions

aerosolized iloprost DRUG

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthias Gorenflo, MD, PhD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 6, 2005
• First Posted: October 10, 2005
• Study Start: May 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

DE (1)