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Milrinone Inhaled 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: NCT00819377
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : October 25, 2013
Heart and stoke fondation of Quebec
Canadian Anesthesiologists' Society
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Valvular Stenosis Valvular Insufficiency Hypertension, Pulmonary Coronary Artery Disease Drug: Milrinone Drug: Normal saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB
Study Start Date : February 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Normal saline
Normal saline by inhalation over 15 min
Drug: Normal saline
5 ml normal saline by inhalation over 15 min
Other Names:
  • Placebo
  • Comparator

Active Comparator: Milrinone
Inhaled milrinone 5 mg(as for the injectable solution)
Drug: Milrinone
inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
  • Milrinone Cardiac Surgery
  • Milrinone inhaled
  • Inhaled milrinone reduces pulmonary artery pressure

Primary Outcome Measures :
  1. 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 Measures :
  1. Reduction in morbidity and mortality post-op [ Time Frame: At discharge, 3 months, 6 months and 1 year by telephone ]
  2. Reduction in pulmonary artery pressure [ Time Frame: Same day before and after CPB ]
  3. Right ventricular function measured using transthoracic echocardiography (TTE) and TEE [ Time Frame: Same day before and after the CPB ]
  4. Serum levels of milrinone in relation with the pharmacodynamic marker [ Time Frame: Same day pre CPB per CPB and post CPB ]
  5. 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 ]

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:

  • 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

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): NCT00819377

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Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Andre Denault
Heart and stoke fondation of Quebec
Canadian Anesthesiologists' Society
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Principal Investigator: Denault André, MD FRCPC Montreal Heart Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andre Denault, MD FRCPC ABIM-CCM, Montreal Heart Institute Identifier: NCT00819377    
Other Study ID Numbers: 08-1004
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013
Keywords provided by Andre Denault, Montreal Heart Institute:
Valvular surgery
pulmonary artery pressure
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arterial Occlusive 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