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

December 11, 2012 updated by: Matthias Gorenflo, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Matthias Gorenflo, MD, PhD, Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iloprost-Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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