Milrinone Inhaled in Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT00819377 |
Recruitment Status :
Completed
First Posted : January 9, 2009
Last Update Posted : October 25, 2013
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Condition or disease | Intervention/treatment | Phase |
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Valvular Stenosis Valvular Insufficiency Hypertension, Pulmonary Coronary Artery Disease | Drug: Milrinone Drug: Normal saline | Phase 2 |
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 |

Arm | Intervention/treatment |
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Placebo Comparator: Normal saline
Normal saline by inhalation over 15 min
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Drug: Normal saline
5 ml normal saline by inhalation over 15 min
Other Names:
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Active Comparator: Milrinone
Inhaled milrinone 5 mg(as for the injectable solution)
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Drug: Milrinone
inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
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- 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 ]
- Reduction in morbidity and mortality post-op [ Time Frame: At discharge, 3 months, 6 months and 1 year by telephone ]
- Reduction in pulmonary artery pressure [ Time Frame: Same day before and after CPB ]
- Right ventricular function measured using transthoracic echocardiography (TTE) and TEE [ Time Frame: Same day before and after the CPB ]
- Serum levels of milrinone in relation with the pharmacodynamic marker [ Time Frame: Same day pre CPB per CPB and post CPB ]
- 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 ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00819377
Canada, Quebec | |
Montreal Heart Institute | |
Montreal, Quebec, Canada, H1T 1C8 |
Principal Investigator: | Denault André, MD FRCPC | Montreal Heart Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Andre Denault, MD FRCPC ABIM-CCM, Montreal Heart Institute |
ClinicalTrials.gov 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 |
Valvular surgery pulmonary artery pressure |
Hypertension, Pulmonary Coronary Artery Disease Vascular Diseases Cardiovascular Diseases Coronary Disease Myocardial Ischemia Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Lung Diseases Respiratory Tract Diseases |
Milrinone 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 |