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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00235521

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Drug: aerosolized iloprost	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.