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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Gorenflo, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00235521
First received: October 6, 2005
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention
Pulmonary Hypertension
Drug: aerosolized iloprost

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

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

Enrollment: 15
Study Start Date: May 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235521

Locations
Germany
University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Matthias Gorenflo, MD, PhD Heidelberg University
  More Information

No publications provided

Responsible Party: Matthias Gorenflo, Prof. Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT00235521     History of Changes
Other Study ID Numbers: Iloprost-Study
Study First Received: October 6, 2005
Last Updated: December 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heidelberg University:
Pulmonary hypertension
Cardiac Surgery
Children
Pediatric Patients
Iloprost
NO
nitric oxide
Pulmonary hypertension after cardiac surgery in pediatric patients, 0 - 2 years old

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Iloprost
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014