Milrinone Inhaled in Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

Conditions
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Valvular Stenosis, Valvular Insufficiency, Hypertension, Pulmonary, Coronary Artery Disease

Intervention / Treatment
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* Drug: Milrinone
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline<br>Normal saline by inhalation over 15 min | Drug: Normal saline<br>* 5 ml normal saline by inhalation over 15 min<br>* Other names: Comparator;|
| Active Comparator: Milrinone<br>Inhaled milrinone 5 mg(as for the injectable solution) | Drug: Milrinone<br>* inhaled milrinone 5 mg (as for the injectable solution)<br>* Other names: Inhaled milrinone reduces pulmonary artery pressure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass |  | End of CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in morbidity and mortality post-op |  | At discharge, 3 months, 6 months and 1 year by telephone | 
| Reduction in pulmonary artery pressure |  | Same day before and after CPB | 
| Right ventricular function measured using transthoracic echocardiography (TTE) and TEE |  | Same day before and after the CPB | 
| Serum levels of milrinone in relation with the pharmacodynamic marker |  | 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), |  | 24 hrs post op and hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valvular surgery, pulmonary artery pressure