Inhaled Milrinone in Cardiac Surgery

Study Overview
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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.

Official Title
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Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: Inhaled milrinone 5 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled milrinone 5 mg<br>Inhaled milrinone 5 mg(as for the injectable solution) | Drug: Inhaled milrinone 5 mg<br>* Inhaled milrinone 5 mg (as for the injectable solution)<br>* Other names: Primacor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the elimination rate of milrinone administered by inhalation |  | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone | 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. | 15 min after the of study drug administration | 
| Confirmation of the safety of inhaled milrinone | Verification of the absence of deleterious effects on cardiac output and systemic arterial pressure. | 24 hours after cardiac surgery | 
| Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension | Efficacy in the treatment of pulmonary hypertension is defined as a reduction of the mean pulmonary pressure of 10-20 % | 15 min after end of milrinone administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary hypertension, Cardiac surgery, Cardiopulmonary Bypass (CPB)