search
Back to results

Inhaled Milrinone in Cardiac Surgery

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Inhaled milrinone 5 mg
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled milrinone 5 mg

Arm Description

Inhaled milrinone 5 mg(as for the injectable solution)

Outcomes

Primary Outcome Measures

Study the elimination rate of milrinone administered by inhalation

Secondary Outcome Measures

Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
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.
Confirmation of the safety of inhaled milrinone
Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %

Full Information

First Posted
June 18, 2012
Last Updated
November 8, 2012
Sponsor
Montreal Heart Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, St. Justine's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01725776
Brief Title
Inhaled Milrinone in Cardiac Surgery
Official Title
Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, St. Justine's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Milrinone elimination will be verify with blood and urine samples analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled milrinone 5 mg
Arm Type
Experimental
Arm Description
Inhaled milrinone 5 mg(as for the injectable solution)
Intervention Type
Drug
Intervention Name(s)
Inhaled milrinone 5 mg
Other Intervention Name(s)
Primacor
Intervention Description
Inhaled milrinone 5 mg (as for the injectable solution)
Primary Outcome Measure Information:
Title
Study the elimination rate of milrinone administered by inhalation
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
Description
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.
Time Frame
15 min after the of study drug administration
Title
Confirmation of the safety of inhaled milrinone
Description
Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure.
Time Frame
24 hours after cardiac surgery
Title
Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
Description
Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 %
Time Frame
15 min after end of milrinone administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrée Denault, MD PhD FRCPC
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Inhaled Milrinone in Cardiac Surgery

We'll reach out to this number within 24 hrs