Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

Study Overview
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Brief Summary
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The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.

Detailed Description
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The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.

Official Title
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Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

Conditions
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Anesthesia

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


Participation Criteria
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Eligibility Criteria
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Eligibility criteria: elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. PH was defined as a mean pulmonary artery pressure (MPAP) 30 mmHg or a systolic pulmonary artery pressure (SPAP) 40 mmHg, measured during preoperative right-sided catheterization or estimated by using doppler transthoracic echocardiography. Exclusion Criteria: Cardiac surgery without CPB. Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device). Adult congenital heart disease planned for corrective surgery. Contraindication to transesophageal echocardiography (TEE). Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (Group A) will receive milrinone<br>Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization | Drug: Milrinone<br>* will be given by nebulization<br>|
| Placebo Comparator: (Group B) will receive normal saline<br>Patients will receive 5 ml saline by nebulization over 5 min | Drug: Normal saline<br>* will be given by nebuliztion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of inhaled milrinone on improvement of right ventricular function | The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative) | After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit |