Milrinone Inhaled in Cardiac Surgery

Phase 2

Completed

• Conditions: Valvular Stenosis; Valvular Insufficiency; Hypertension, Pulmonary; Coronary Artery Disease
• Interventions: Drug: Normal saline; Drug: Milrinone

• Registration Number: NCT00819377
• Lead Sponsor: Andre Denault

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.

Study Timeline

• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Study Start: 2009-02
• Primary Completion: 2012-01
• Study Completion: 2012-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Normal saline by inhalation over 15 min
Milrinone	Milrinone	Inhaled milrinone 5 mg(as for the injectable solution)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Serum levels of milrinone in relation with the pharmacodynamic marker	Same day pre CPB per CPB and post CPB

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada