Status:
COMPLETED
Milrinone Inhaled in Cardiac Surgery
Lead Sponsor:
Andre Denault
Collaborating Sponsors:
Heart and stoke fondation of Quebec
Organon
Conditions:
Valvular Stenosis
Valvular Insufficiency
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmona...
Detailed Description
This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before ...
Eligibility Criteria
Inclusion
- Adult patients scheduled for elective valvular or complex (2 or more valves or
- valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
- systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).
Exclusion
- Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
- Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00819377
Start Date
February 1 2009
End Date
December 1 2012
Last Update
October 25 2013
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8