Pulmonary HypertensionPhase 2NCT01370096
Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension
A Phase 2 study testing Vasopressin infusion and Vasopressin infusion and epoprostenol inhalation in people with Pulmonary Hypertension, run by University of Alberta at 1 site in Canada.
Trial summary
To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Vasopressin infusion and Vasopressin infusion and epoprostenol inhalation
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Sep 2016
- Phase
- Phase 2
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patients with pulmonary hypertension defined as a mean pulmonary artery pressure ≥ 25mmHg undergoing diagnostic cardiac catheterization for clinical purposes are potential subjects. Subjects must have preserved left ventricular function (ejection fraction ≥ 40 %). Subjects must have parental consent for enrollment.
Who cannot join
- Any patient with left ventricular dysfunction (EF < 40%).
- Any patient with known pulmonary veno-occlusive disease
Trial locations and contacts
1 site in 1 country.
About this study
To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. The investigators do not know the best medicine(s) to help children with pulmonary hypertension when their right ventricles fail. The purpose of the study is to look at the effects of two different medicines on the blood pressure in the lungs of a child with pulmonary hypertension. The investigators hope to then be able to choose the best medicine for children with pulmonary hypertension and right ventricular failure.
The first medicine is called vasopressin. It is a hormone that your body makes on its own. The investigators will be giving it through an intravenous infusion. The investigators think that vasopressin works differently in different parts of your body. The investigators are looking to see the different effects that vasopressin has in the lungs compared to the rest of the body.
The second medicine is called prostacyclin and is something that your body also makes by itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary hypertension as it decreases pressure in the blood vessels. In the catheterization laboratory, patients breathe in this medicine to measure specific changes in the blood pressure in their lungs.
Read the detailed description
Background:
Pulmonary hypertension (PH) is a rare, but devastating disease that affects both adult and pediatric patients. Mortality is high with 84% survival at one year and 50% survival at five years in adult populations despite treatment. The cause of death is typically either from right ventricular failure or sudden cardiac death, likely secondary to a pulmonary hypertensive crisis. The resuscitation of patients with PH after cardiac arrest is extremely difficult. The use of epinephrine, a pulmonary vasoconstrictor, during resuscitation may impair filling of the left ventricle. The ideal resuscitation drug(s) would dilate the pulmonary vascular bed to help fill the left ventricle while constricting the systemic vascular bed to maintain coronary perfusion.
Objectives:
The assessment of pulmonary vascular reactivity is critical to the clinical management of patients with pulmonary hypertension (PH). The goals of this pilot study include determination of the hemodynamic effects of low dose vasopressin infusion and the effects of a combination of low dose vasopressin infusion and inhaled prostacyclin in a population of pediatric patients with PH.
Methods:
The investigators propose a prospective, pilot study to examine the acute hemodynamic effects of low dose vasopressin infusion and the combination of low dose vasopressin infusion and inhaled prostacyclin in pediatric pulmonary hypertension patients. The investigators anticipate recruiting 10 pediatric patients with pulmonary hypertension over the course of one year.
Study Protocol:
The study will be performed in the cardiac catheterization laboratory. All subjects will be intubated and mechanically ventilated for the study as per laboratory protocol. Sedation and anesthesia will be performed at the discretion of the pediatric anesthesiologist to provide a consistent anesthetic during the period of hemodynamic study. Arterial and venous access will be obtained via the femoral approach by standard techniques. Right and left catheterization will be performed to record hemodynamic measurements at baseline and after pulmonary vasoreactivity testing with oxygen and nitric oxide as per usual. Catheterization data to be collected includes right atrial pressure, systolic, diastolic and mean pulmonary artery pressure, pulmonary capillary wedge pressure, systemic arterial pressure, cardiac index, pulmonary vascular resistance (PVR) index, systemic vascular resistance (SVR) index and PVR/SVR ratio. After a period of time to allow for nitric oxide washout, acute vasoreactivity testing to assess the hemodynamic response to low dose vasopressin infusion followed by the combination of low dose vasopressin infusion and inhaled PGI2 will be performed.
- Conditions
- Pulmonary Hypertension
- Being tested
- Vasopressin infusion, Vasopressin infusion and epoprostenol inhalation
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin infusionDrug
An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure.
Vasopressin infusion and epoprostenol inhalationDrug
Also called Flolan
An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure. If the target 20% increase in SBP is not achieved with vasopressin titration, the infusion will remain at 0.002U/kg/min. After a period of ten minutes of drug exposure to allow for patient equilibration, subjects will receive nebulized prostacyclin at a dose of 50ng/kg/min for 15 minutes via Aeroneb into the endotracheal tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
PVR/SVR indexed ratio
Cardiac cath data
Measured: Within 15 minutes of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Difficulty with patient recruitment
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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Ryerson, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370096
- Sponsor's protocol ID
- 2011-LR-001
- Status last verified
- Dec 2018
- First submitted
- 8 Jun 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin and Inhaled Prostacyclin in Pediatric Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT01370096
- Acronym / sponsor ID
- 2011-LR-001
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with patient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Jun 2011 (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.
To diagnose pulmonary hypertension, children have a cardiac catheterization to check the blood pressure in their lungs. Children with pulmonary hypertension have high blood pressure in their lungs. The right ventricle of the heart has to do more work to pump against this higher pressure. The investigators do not know the best medicine(s) to help children with pulmonary hypertension when their right ventricles fail. The purpose of the study is to look at the effects of two different medicines on the blood pressure in the lungs of a child with pulmonary hypertension. The investigators hope to then be able to choose the best medicine for children with pulmonary hypertension and right ventricular failure.
The first medicine is called vasopressin. It is a hormone that your body makes on its own. The investigators will be giving it through an intravenous infusion. The investigators think that vasopressin works differently in different parts of your body. The investigators are looking to see the different effects that vasopressin has in the lungs compared to the rest of the body.
The second medicine is called prostacyclin and is something that your body also makes by itself. Prostacyclin, given via an intravenous infusion, is a treatment for pulmonary hypertension as it decreases pressure in the blood vessels. In the catheterization laboratory, patients breathe in this medicine to measure specific changes in the blood pressure in their lungs.
Detailed description
Background:
Pulmonary hypertension (PH) is a rare, but devastating disease that affects both adult and pediatric patients. Mortality is high with 84% survival at one year and 50% survival at five years in adult populations despite treatment. The cause of death is typically either from right ventricular failure or sudden cardiac death, likely secondary to a pulmonary hypertensive crisis. The resuscitation of patients with PH after cardiac arrest is extremely difficult. The use of epinephrine, a pulmonary vasoconstrictor, during resuscitation may impair filling of the left ventricle. The ideal resuscitation drug(s) would dilate the pulmonary vascular bed to help fill the left ventricle while constricting the systemic vascular bed to maintain coronary perfusion.
Objectives:
The assessment of pulmonary vascular reactivity is critical to the clinical management of patients with pulmonary hypertension (PH). The goals of this pilot study include determination of the hemodynamic effects of low dose vasopressin infusion and the effects of a combination of low dose vasopressin infusion and inhaled prostacyclin in a population of pediatric patients with PH.
Methods:
The investigators propose a prospective, pilot study to examine the acute hemodynamic effects of low dose vasopressin infusion and the combination of low dose vasopressin infusion and inhaled prostacyclin in pediatric pulmonary hypertension patients. The investigators anticipate recruiting 10 pediatric patients with pulmonary hypertension over the course of one year.
Study Protocol:
The study will be performed in the cardiac catheterization laboratory. All subjects will be intubated and mechanically ventilated for the study as per laboratory protocol. Sedation and anesthesia will be performed at the discretion of the pediatric anesthesiologist to provide a consistent anesthetic during the period of hemodynamic study. Arterial and venous access will be obtained via the femoral approach by standard techniques. Right and left catheterization will be performed to record hemodynamic measurements at baseline and after pulmonary vasoreactivity testing with oxygen and nitric oxide as per usual. Catheterization data to be collected includes right atrial pressure, systolic, diastolic and mean pulmonary artery pressure, pulmonary capillary wedge pressure, systemic arterial pressure, cardiac index, pulmonary vascular resistance (PVR) index, systemic vascular resistance (SVR) index and PVR/SVR ratio. After a period of time to allow for nitric oxide washout, acute vasoreactivity testing to assess the hemodynamic response to low dose vasopressin infusion followed by the combination of low dose vasopressin infusion and inhaled PGI2 will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric patients with pulmonary hypertension defined as a mean pulmonary artery pressure ≥ 25mmHg undergoing diagnostic cardiac catheterization for clinical purposes are potential subjects. Subjects must have preserved left ventricular function (ejection fraction ≥ 40 %). Subjects must have parental consent for enrollment.
Key exclusion criteria (2 listed)
- Any patient with left ventricular dysfunction (EF < 40%).
- Any patient with known pulmonary veno-occlusive disease
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 |
|---|---|---|
| Vasopressin infusionAn intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure. | Drug | – |
| Vasopressin infusion and epoprostenol inhalationAlso: FlolanAn intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure. If the target 20% increase in SBP is not achieved with vasopressin titration, the infusion will remain at 0.002U/kg/min. After a period of ten minutes of drug exposure to allow for patient equilibration, subjects will receive nebulized prostacyclin at a dose of 50ng/kg/min for 15 minutes via Aeroneb into the endotracheal tube. | Drug | – |
Primary outcome
PVR/SVR indexed ratio
Time frame: Within 15 minutes of intervention
Cardiac cath data
Results and safety
The study was stopped early (reason given: Difficulty with patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vasopressin infusion and Vasopressin infusion and epoprostenol inhalation in people with Pulmonary Hypertension, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Dec 2018. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with patient recruitment). Results are not available in the source record.
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?
PVR/SVR indexed ratio (time frame: Within 15 minutes of intervention). 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 19 Dec 2018.