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NCT Number: NCT04484675

Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

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

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Key information

Conditions

Pulmonary Hypertension Due to Left Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location status: Recruiting

Location contact

Heba M Elasser, MD

CONTACT

[email protected]

01062393152

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milrinone inhalation

Drug

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

Other names: primacor

Milrinone infusion

Drug

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

Other names: primacor

Primary outcomes

  1. mean arterial pressure

    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)

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

Secondary outcomes

  1. mean pulmonary arterial pressure

    Time frame: change in mean pulmonary arterial pressure 10 minutes after milrinone administration

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

  2. systemic vascular resistance

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

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

  3. pulmonary vascular resistance

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amany S abdelazeem, MD

CONTACT

[email protected]

01287220016

Heba M EL-Asser, MD

CONTACT

[email protected]

01062393152

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2020
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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