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Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery

NCT05838846 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-11

No results posted yet for this study

Summary

This prospective open-label randomized study aims to compare the effect of inhaled versus intravenous milrinone on the pulmonary vascular resistance in patients undergoing mitral valve replacement surgery.

The primary outcome is to determine change in pulmonary artery pressure. The secondary outcomes include,

* Incidence of systemic hypotension.
* Hemodynamic affection and need of vasopressors and inotropes.
* Change in pulmonary vascular resistance versus systemic vascular resistance.
* Right ventricular function.
* Duration of mechanical ventilation.
* Need for mechanical circulatory support devices.
* Urine output
* Length of intensive care (ICU) in stay.

As the investigators hypothesize that inhaled milrinone has a selective pulmonary vasodilator effect devoid of the systemic hypotension with the intravenous administration.

Conditions

  • Mitral Valve Replacement
  • Pulmonary Hypertension
  • Inhaled Milrinone
  • Intravenous Milrinone

Interventions

DRUG

Inhaled Milrinone

Patients will receive 2 doses of inhaled milrinone at the following time points (after sternotomy and after aortic cross clamp off) at dosage of 50 mcg/kg by nebulization, inhaled milrinone will be administered through Aerogen solo with Pro-X controller - continuous mode- attached to ventilator circuit distal to viral/ bacterial heat and moisture exchange filter.

DRUG

IV Milrinone

Patients will receive intravenous milrinone infusion at dosage of 0.3 - 0.75 mcg/kg/min with loading dose of 50 mcg/kg over 10 min. After cross clamp off and temperature of 32 degree, Pulmonary vascular resistance and systemic vascular resistance will be calculated at the same corresponding time points to group A.

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Principal Investigators

  • Ghada A Hassan, Professor · Faculty of Medicine - Menoufia University

  • Mohamed A Salem, A. Professor · Faculty of Medicine - Menoufia University

  • Khaled M Gaballah, A. Professor · Faculty of Medicine - Menoufia University

  • Mohammed O El Gouhary, Lecturer · Faculty of Medicine - Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05838846 on ClinicalTrials.gov