Clinical trial NCT00819377: Milrinone Inhaled in Cardiac Surgery
Official title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Valvular Stenosis
Valvular Insufficiency
Hypertension, Pulmonary
Coronary Artery Disease
Keywords: Valvular surgery
pulmonary artery pressure
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Heart and stoke fondation of Quebec
name: Organon
name: Canadian Anesthesiologists' Society
First posted: 2009-01-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.

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 the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass
timeFrame: End of CPB
Secondary outcomes:
measure: Reduction in morbidity and mortality post-op
timeFrame: At discharge, 3 months, 6 months and 1 year by telephone
measure: Reduction in pulmonary artery pressure
timeFrame: Same day before and after CPB
measure: Right ventricular function measured using transthoracic echocardiography (TTE) and TEE
timeFrame: Same day before and after the CPB
measure: Serum levels of milrinone in relation with the pharmacodynamic marker
timeFrame: Same day pre CPB per CPB and post CPB
measure: reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),
timeFrame: 24 hrs post op and hospital discharge
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Denault André, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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