- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01725776
Inhaled Milrinone in Cardiac Surgery
November 8, 2012 updated by: Andre Denault, Montreal Heart Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Milrinone elimination will be verify with blood and urine samples analysis.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
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
-
-
Quebec
-
Montreal, Quebec, Canada
- Montreal Heart Institute
-
-
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Open Heart Surgery
- Contraindication to transesophageal echocardiography (TEE)
- Hemodynamic instability before surgery
- Emergency 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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg(as for the injectable solution)
|
Inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Study the elimination rate of milrinone administered by inhalation
Time Frame: up to 24 hours
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
15 min after the of study drug administration
|
Confirmation of the safety of inhaled milrinone
Time Frame: 24 hours after cardiac surgery
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Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
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24 hours after cardiac surgery
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Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Time Frame: 15 min after end of milrinone administration
|
Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
|
15 min after end of milrinone administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrée Denault, MD PhD FRCPC, Montreal Heart Institute
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
December 1, 2006
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
November 8, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension
- Hypertension, Pulmonary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Platelet Aggregation Inhibitors
- Protective Agents
- Cardiotonic Agents
- Phosphodiesterase Inhibitors
- Phosphodiesterase 3 Inhibitors
- Milrinone
Other Study ID Numbers
- ICM 06-888
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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