Milrinone Inhaled in Cardiac Surgery

Phase 2CompletedNCT00819377

Andre Denault124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

124

Conditions

Valvular Stenosis Valvular Insufficiency Hypertension, Pulmonary Coronary Artery Disease

Interventions

MilrinoneDRUG

inhaled milrinone 5 mg (as for the injectable solution)

Normal salineDRUG

5 ml normal saline by inhalation over 15 min

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: End of CPB

Secondary Outcomes

Reduction in morbidity and mortality post-op

Time frame: At discharge, 3 months, 6 months and 1 year by telephone

Reduction in pulmonary artery pressure

Time frame: Same day before and after CPB

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

Time frame: Same day before and after the CPB

Serum levels of milrinone in relation with the pharmacodynamic marker

Time frame: 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),

Time frame: 24 hrs post op and hospital discharge

Data from ClinicalTrials.gov

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