Milrinone Inhaled in Cardiac Surgery

Condition(s) targeted: Valvular Stenosis; Valvular Insufficiency; Hypertension, Pulmonary; Coronary Artery Disease

Intervention: Milrinone (Drug); Normal saline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Andre Denault

Official(s) and/or principal investigator(s):
Denault André, MD FRCPC, Principal Investigator, Affiliation: Montreal Heart Institute

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.

Official title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass

Secondary outcome:

Reduction in morbidity and mortality post-op

Reduction in pulmonary artery pressure

Right ventricular function measured using transthoracic echocardiography (TTE) and TEE

Serum levels of milrinone in relation with the pharmacodynamic marker

reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),

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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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

Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada

Related publications:

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Starting date: February 2009
Last updated: October 23, 2013