Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Study Overview
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Brief Summary
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The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Detailed Description
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Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Official Title
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Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery

Conditions
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Pulmonary Hypertension Due to Left Heart Disease

Intervention / Treatment
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* Drug: Milrinone inhalation
* Drug: Milrinone infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =>55 estimated by using preoperative Doppler echocardiography Exclusion Criteria: Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (deﬁned as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease , coagulopathy, and thromboembolic disease treated with anticoagulants

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group IH(inhaled milrinone)<br>After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered | Drug: Milrinone inhalation<br>* After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered<br>* Other names: primacor;|
| Active Comparator: Group Iv(Intravenous milrinone)<br>After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered | Drug: Milrinone infusion<br>* After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered<br>* Other names: primacor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial pressure | The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone | change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pulmonary arterial pressure | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone | change in mean pulmonary arterial pressure 10 minutes after milrinone administration | 
| systemic vascular resistance | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone | change in systemic vascular resistance 10 minutes after milrinone administration | 
| pulmonary vascular resistance | The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone | change in pulmonary vascular resistance 10 minutes after milrinone administration |