Pulmonary HypertensionPhase 2NCT01725776
Inhaled Milrinone in Cardiac Surgery
A Phase 2 study testing Inhaled milrinone 5 mg in people with Pulmonary Hypertension, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Inhaled milrinone 5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Jun 2012
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cardiac surgery under CPB
- High risk patients: NYHA class II-III
- Preoperative diagnostic of pulmonary hypertension:
- Systolic pulmonary artery pressure (sPAP) > 35 mm Hg; or
- Mean pulmonary artery pressure (mPAP) > 25 mm Hg; or
- mAP/mPAP < 3.0 (after induction of anesthesia).
Who cannot join
- Open Heart Surgery
- Contraindication to transesophageal echocardiography (TEE)
- Hemodynamic instability before surgery
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
Read the detailed description
Milrinone elimination will be verify with blood and urine samples analysis.
- Conditions
- Pulmonary Hypertension
- Being tested
- Inhaled milrinone 5 mg
- Keywords
- Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled milrinone 5 mgDrug
Also called Primacor
Inhaled milrinone 5 mg (as for the injectable solution)
| Study group | Role | What they receive |
|---|---|---|
| Inhaled milrinone 5 mg | Experimental | Inhaled milrinone 5 mg(as for the injectable solution) Receives: Drug: Inhaled milrinone 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the elimination rate of milrinone administered by inhalation
Measured: up to 24 hours
Secondary outcomes (3)
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
hemodynamic values evaluated will be: central venous pressure, systolic and diastolic pulmonary pressure, wedge, cardiac output, cardiac frequency, systolic and diastolic pressure, SaO2, EtCO2. Patient will also have arterial and venous gaz. Echographic values will be evaluated to see the cardiac fonction: left and right ventricular systolic and diastolic function and valvular function.
Measured: 15 min after the of study drug administration
Confirmation of the safety of inhaled milrinone
Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
Measured: 24 hours after cardiac surgery
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
Measured: 15 min after end of milrinone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startDec 2006
- Primary completionFeb 2012
- Study completionJun 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, St. Justine's Hospital
- Responsible party
- Principal investigator, Andre Denault, Montreal Heart Institute
- Investigators
- Andrée Denault, MD PhD FRCPC, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725776
- Sponsor's protocol ID
- ICM 06-888
- Status last verified
- Nov 2012
- First submitted
- 18 Jun 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT01725776
- Acronym / sponsor ID
- ICM 06-888
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, St. Justine's Hospital
- Study start
- Dec 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Nov 2012 (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.
The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.
Detailed description
Milrinone elimination will be verify with blood and urine samples analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled milrinone 5 mg | Experimental | Drug: Inhaled milrinone 5 mgInhaled milrinone 5 mg(as for the injectable solution) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for elective cardiac surgery under CPB
- High risk patients: NYHA class II-III
- Preoperative diagnostic of pulmonary hypertension:
Key exclusion criteria (4 listed)
- Open Heart Surgery
- Contraindication to transesophageal echocardiography (TEE)
- Hemodynamic instability before surgery
- Emergency surgery
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 |
|---|---|---|
| Inhaled milrinone 5 mgAlso: PrimacorInhaled milrinone 5 mg (as for the injectable solution) | Drug | Inhaled milrinone 5 mg |
Primary outcome
Study the elimination rate of milrinone administered by inhalation
Time frame: up to 24 hours
3 secondary outcomes
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
Time frame: 15 min after the of study drug administration
Confirmation of the safety of inhaled milrinone
Time frame: 24 hours after cardiac surgery
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Time frame: 15 min after end of milrinone administration
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 14 Nov 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.
Andrée Denault, MD PhD FRCPC principal investigator
Montreal Heart Institute
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 Inhaled milrinone 5 mg in people with Pulmonary Hypertension, run by Montreal Heart Institute 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 6 inclusion and 4 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 14 Nov 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 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 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?
Study the elimination rate of milrinone administered by inhalation (time frame: up to 24 hours). 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 14 Nov 2012.