Pulmonary HypertensionNCT00235521
Iloprost-Study: Comparison of Nitric Oxide to Iloprost (Ventavis) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
A study testing aerosolized iloprost in people with Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- aerosolized iloprost
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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.
Who cannot join
- Specific cardiac defects:
- Atrial septal defect (ASD)
- Cyanotic congenital heart disease
- Univentricular atrio-ventricular - connexion
- Valvular or subvalvular pulmonary or aortic stenosis
- Specific circumstances:
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Medical Faculty, Department of Pediatric Cardiology
Heidelberg, 69120
About this study
Official title: 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.
Read the 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
- Conditions
- Pulmonary Hypertension
- Being tested
- aerosolized iloprost
- Keywords
- Pulmonary hypertension, Cardiac Surgery, Children, Pediatric Patients, Iloprost, NO, nitric oxide, Pulmonary hypertension after cardiac surgery in pediatric patients, 0 - 2 years old
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerosolized iloprostDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Gorenflo, Heidelberg University
- Investigators
- Matthias Gorenflo, MD, PhD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235521
- Sponsor's protocol ID
- Iloprost-Study
- Status last verified
- Dec 2012
- First submitted
- 6 Oct 2005
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inhaled Nitric Oxide With Aerosolized Iloprost (Ventavis®) for Treatment of Pulmonary Hypertension in Children After Cardiopulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT00235521
- Acronym / sponsor ID
- Iloprost-Study
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- Presence of postoperative PH immediately after intracardiac repair:
Key exclusion criteria (16 listed)
- Specific cardiac defects:
- Specific circumstances:
- Concomitant diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerosolized iloprost | Drug | – |
Primary outcome
Number of pulmonary hypertensive crises (major and/or minor)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Gorenflo, MD, PhD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerosolized iloprost in people with Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pulmonary hypertensive crises (major and/or minor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.