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Milrinone Inhaled in Cardiac Surgery

Primary Purpose

Valvular Stenosis, Valvular Insufficiency, Hypertension, Pulmonary

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Milrinone

Normal saline

About this trial

This is an interventional treatment trial for Valvular Stenosis focused on measuring Valvular surgery, pulmonary artery pressure

Eligibility Criteria

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

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

Sites / Locations

Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal saline

Milrinone

Arm Description

Normal saline by inhalation over 15 min

Inhaled milrinone 5 mg(as for the injectable solution)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction in morbidity and mortality post-op

Reduction in pulmonary artery pressure

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

Serum levels of milrinone in relation with the pharmacodynamic marker

reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest),

Full Information

NCT ID

NCT00819377

First Posted

January 8, 2009

Last Updated

October 23, 2013

Sponsor

Andre Denault

Collaborators

Heart and stoke fondation of Quebec, Organon, Canadian Anesthesiologists' Society

1. Study Identification

Unique Protocol Identification Number

NCT00819377

Brief Title

Milrinone Inhaled in Cardiac Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andre Denault

Collaborators

Heart and stoke fondation of Quebec, Organon, Canadian Anesthesiologists' Society

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Valvular Stenosis, Valvular Insufficiency, Hypertension, Pulmonary, Coronary Artery Disease

Keywords

Valvular surgery, pulmonary artery pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal saline

Arm Type

Placebo Comparator

Arm Description

Normal saline by inhalation over 15 min

Arm Title

Milrinone

Arm Type

Active Comparator

Arm Description

Inhaled milrinone 5 mg(as for the injectable solution)

Intervention Type

Drug

Intervention Name(s)

Milrinone

Other Intervention Name(s)

Milrinone Cardiac Surgery, Milrinone inhaled, Inhaled milrinone reduces pulmonary artery pressure

Intervention Description

inhaled milrinone 5 mg (as for the injectable solution)

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Placebo, Comparator

Intervention Description

5 ml normal saline by inhalation over 15 min

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Reduction in morbidity and mortality post-op

Time Frame

At discharge, 3 months, 6 months and 1 year by telephone

Title

Reduction in pulmonary artery pressure

Time Frame

Same day before and after CPB

Title

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

Time Frame

Same day before and after the CPB

Title

Serum levels of milrinone in relation with the pharmacodynamic marker

Time Frame

Same day pre CPB per CPB and post CPB

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denault André, MD FRCPC

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal Heart Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

12. IPD Sharing Statement

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Milrinone Inhaled in Cardiac Surgery

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