Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

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

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension Due to Left Heart Disease
• Intervention / Treatment: Drug: Milrinone inhalation; Drug: Milrinone infusion

Detailed Description

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
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heba M EL-Asser, MD; Phone Number: 01062393152; Email: aseelaswad1@yahoo.com
• Study Contact Backup: Name: Amany S abdelazeem, MD; Phone Number: 01287220016; Email: dola.salah2009@gmail.com

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Recruiting
      • Zagazig University
      • Contact: Heba M Elasser, MD; Phone Number: 01062393152; Email: aseelaswad1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group IH(inhaled milrinone); 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; 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
Active Comparator: Group Iv(Intravenous milrinone); 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Heba M EL-Asser, MD, Zagazig University

Publications and helpful links

General Publications

• Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
• Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Heart Diseases; Hypertension, Pulmonary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Cardiotonic Agents; Vasodilator Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Milrinone
• Other Study ID Numbers: milrinone in cardiadc surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No