Coronary Artery Disease, Hypertension, Pulmonary, Valvular Insufficiency, Valvular Stenosis
Conditions
Keywords
Valvular surgery, pulmonary artery pressure
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.
Interventions
DRUGMilrinone
inhaled milrinone 5 mg (as for the injectable solution)
DRUGNormal saline
5 ml normal saline by inhalation over 15 min
Sponsors
Heart and stoke fondation of Quebec
Organon
Canadian Anesthesiologists' Society
Andre Denault
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass | End of CPB |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in morbidity and mortality post-op | At discharge, 3 months, 6 months and 1 year by telephone |
| Reduction in pulmonary artery pressure | Same day before and after CPB |
| Right ventricular function measured using transthoracic echocardiography (TTE) and TEE | Same day before and after the CPB |
| Serum levels of milrinone in relation with the pharmacodynamic marker | Same day pre CPB per CPB and post CPB |
| reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest), | 24 hrs post op and hospital discharge |
Countries
Canada
Outcome results
None listed