Inhaled Milrinone in Cardiac Surgery

NCT ID: NCT01725776

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-06-30

Brief Summary

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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

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

Conditions

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Pulmonary Hypertension

Keywords

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Pulmonary hypertension Cardiac surgery Cardiopulmonary Bypass (CPB)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Inhaled milrinone 5 mg

Inhaled milrinone 5 mg(as for the injectable solution)

Group Type EXPERIMENTAL

Inhaled milrinone 5 mg

Intervention Type DRUG

Inhaled milrinone 5 mg (as for the injectable solution)

Interventions

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Inhaled milrinone 5 mg

Inhaled milrinone 5 mg (as for the injectable solution)

Intervention Type DRUG

Other Intervention Names

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Primacor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role collaborator

Montreal Heart Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Denault

MD PhD FRCPC ABIM-CCM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrée Denault, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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ICM 06-888

Identifier Type: -

Identifier Source: org_study_id