Milrinone Inhaled in Cardiac Surgery

October 23, 2013 updated by: Andre Denault

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Normal saline
Normal saline by inhalation over 15 min
Drug: Normal saline
5 ml normal saline by inhalation over 15 min
Other Names:
  • Placebo
  • Comparator
ACTIVE_COMPARATOR: Milrinone
Inhaled milrinone 5 mg(as for the injectable solution)
Drug: Milrinone
inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
  • Milrinone Cardiac Surgery
  • Milrinone inhaled
  • Inhaled milrinone reduces pulmonary artery pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of CPB

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in morbidity and mortality post-op
Time Frame: At discharge, 3 months, 6 months and 1 year by telephone
At discharge, 3 months, 6 months and 1 year by telephone
Reduction in pulmonary artery pressure
Time Frame: Same day before and after CPB
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
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
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
24 hrs post op and hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andre Denault

Collaborators

Organon
Canadian Anesthesiologists' Society
Heart and stoke fondation of Quebec

Investigators

  • Principal Investigator: Denault André, MD FRCPC, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (ESTIMATE)

January 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-1004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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