Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Phase 4

Recruiting

• Conditions: Pulmonary Hypertension Due to Left Heart Disease
• Interventions: Drug: Milrinone inhalation; Drug: Milrinone infusion

• Registration Number: NCT04484675
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Study Start: 2023-05-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group IH(inhaled milrinone)	Milrinone inhalation	After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
Group Iv(Intravenous milrinone)	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

Primary Outcome Measures

Name	Time	Method
mean arterial pressure	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 Outcome Measures

Name	Time	Method
pulmonary vascular resistance	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
mean pulmonary arterial pressure	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
systemic vascular resistance	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

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt