Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Phase 4RecruitingNCT04484675

Zagazig University38 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Hypertension Due to Left Heart Disease

Interventions

Milrinone inhalationDRUG

After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered

Milrinone infusionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Zagazig University

Zagazig, Sharqia Province, Egypt

RECRUITING

Outcomes

Primary Outcomes

mean arterial pressure

The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone

Time frame: 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 Outcomes

mean pulmonary arterial pressure

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time frame: 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

Time frame: 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

Time frame: change in pulmonary vascular resistance 10 minutes after milrinone administration

Central Contacts

Heba M EL-Asser, MD

CONTACT

01062393152 aseelaswad1@yahoo.com

Amany S abdelazeem, MD

CONTACT

01287220016 dola.salah2009@gmail.com

Data from ClinicalTrials.gov

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