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Inhaled Milrinone in Cardiac Surgery

Information source: Montreal Heart Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Inhaled milrinone 5 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Montreal Heart Institute

Official(s) and/or principal investigator(s):
Andrée Denault, MD PhD FRCPC, Principal Investigator, Affiliation: Montreal Heart Institute


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.

Clinical Details

Official title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Study the elimination rate of milrinone administered by inhalation

Secondary outcome:

Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone

Confirmation of the safety of inhaled milrinone

Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension

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


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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

Locations and Contacts

Montreal Heart Institute, Montreal, Quebec, Canada
Additional Information

Starting date: December 2006
Last updated: November 8, 2012

Page last updated: August 23, 2015

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