Inhaled Milrinone in Cardiac Surgery
Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
November 14, 2012
CompletedNovember 14, 2012
November 1, 2012
5.2 years
June 18, 2012
November 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study the elimination rate of milrinone administered by inhalation
up to 24 hours
Secondary Outcomes (3)
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
15 min after the of study drug administration
Confirmation of the safety of inhaled milrinone
24 hours after cardiac surgery
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
15 min after end of milrinone administration
Study Arms (1)
Inhaled milrinone 5 mg
EXPERIMENTALInhaled milrinone 5 mg(as for the injectable solution)
Interventions
Inhaled milrinone 5 mg (as for the injectable solution)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Open Heart Surgery
- Contraindication to transesophageal echocardiography (TEE)
- Hemodynamic instability before surgery
- Emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montreal Heart Institutelead
- Canadian Institutes of Health Research (CIHR)collaborator
- Fonds de la Recherche en Santé du Québeccollaborator
- St. Justine's Hospitalcollaborator
Study Sites (1)
Montreal Heart Institute
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrée Denault, MD PhD FRCPC
Montreal Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD FRCPC ABIM-CCM
Study Record Dates
First Submitted
June 18, 2012
First Posted
November 14, 2012
Study Start
December 1, 2006
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
November 14, 2012
Record last verified: 2012-11