Fact CheckerSign in

NCT05838846CompletedPhase 2/3

Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery

Source: ClinicalTrials.gov · Last updated 11 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
60 (actual)
First submitted
6 Apr 2023
Start date
1 Apr 2023
Primary completion date
1 Jan 2025
Lead sponsor
Menoufia University
NCT number
NCT05838846

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 60
  • From 1 Apr 2023 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Contraindication to transesophageal echocardiography; esophageal stricture, tumor or diverticulum or active upper gastrointestinal bleeding

Other

  • Patients with aortic valvular lesions or pulmonary stenosis.
  • Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
  • Patients with hepatic or renal dysfunction.
  • Patients with coagulopathy.
  • Emergency surgeries.

Who the study is looking for

  • Severe mitral regurgitation and moderate or severe pulmonary hypertension
  • Scheduled for mitral valve replacement surgery
    • \# Criteria of severe mitral regurgitation:
  • Central jet MR \>40% LA or holosystolic eccentric jet MR
  • Vena contracta ≥ 0.7 cm
  • Regurgitant volume ≥60 ml
  • Regurgitant fraction ≥50%
  • EROA ≥0.40 cm2
    • \# Criteria of moderate and severe pulmonary hypertension:
  • Moderate pulmonary hypertension; mean pulmonary artery pressure \> 41 mmHg while, severe pulmonary hypertension; mean pulmonary artery pressure \> 55 mmHg
  • Mean pulmonary artery pressure \> 40% of mean systemic blood pressure.
  • Mean pulmonary artery pressure approximated from estimated systolic pulmonary artery pressure as following; mPAP= (estimated sPAP X 0.61) ± 2

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Menoufia University Hospitals
Coordinator of this site? Confirm its status		Shibīn al KawmEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.