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Inhaled Milrinone in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725776
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
St. Justine's Hospital
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Inhaled milrinone 5 mg Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
Study Start Date : December 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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 Name: Primacor

Primary Outcome Measures :
  1. Study the elimination rate of milrinone administered by inhalation [ Time Frame: up to 24 hours ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 %

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725776

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
Montreal Heart Institute
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
St. Justine's Hospital
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Principal Investigator: Andrée Denault, MD PhD FRCPC Montreal Heart Institute

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Responsible Party: Andre Denault, MD PhD FRCPC ABIM-CCM, Montreal Heart Institute Identifier: NCT01725776    
Other Study ID Numbers: ICM 06-888
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Keywords provided by Andre Denault, Montreal Heart Institute:
Pulmonary hypertension
Cardiac surgery
Cardiopulmonary Bypass (CPB)
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiotonic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs