Inhaled Milrinone in Cardiac Surgery

November 8, 2012 updated by: Andre Denault, Montreal Heart Institute

Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Milrinone elimination will be verify with blood and urine samples analysis.

Study Type

Interventional

Enrollment (Actual)

40

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
        • 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:

  • Patients scheduled for elective cardiac surgery under CPB
  • High risk patients: NYHA class II-III

  • Preoperative diagnostic of pulmonary hypertension:

    • Systolic pulmonary artery pressure (sPAP) > 35 mm Hg; or
    • Mean pulmonary artery pressure (mPAP) > 25 mm Hg; or
    • mAP/mPAP < 3.0 (after induction of anesthesia).

Exclusion Criteria:

  • Open Heart Surgery
  • Contraindication to transesophageal echocardiography (TEE)
  • Hemodynamic instability before surgery
  • Emergency surgery

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg(as for the injectable solution)
Drug: Inhaled milrinone 5 mg
Inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
  • Primacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the elimination rate of milrinone administered by inhalation
Time Frame: up to 24 hours
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
Time Frame: 15 min after the of study drug administration
hemodynamic values evaluated will be: central venous pressure, systolic and diastolic pulmonary pressure, wedge, cardiac output, cardiac frequency, systolic and diastolic pressure, SaO2, EtCO2. Patient will also have arterial and venous gaz. Echographic values will be evaluated to see the cardiac fonction: left and right ventricular systolic and diastolic function and valvular function.
15 min after the of study drug administration
Confirmation of the safety of inhaled milrinone
Time Frame: 24 hours after cardiac surgery
Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
24 hours after cardiac surgery
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Time Frame: 15 min after end of milrinone administration
Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
15 min after end of milrinone administration

Collaborators and Investigators

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

Sponsor

Montreal Heart Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
St. Justine's Hospital
Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Andrée Denault, MD PhD FRCPC, Montreal Heart Institute

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

December 1, 2006

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 06-888

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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