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Mitral Valve ReplacementPhase 2/3NCT05838846

Inhaled Versus Intravenous Milrinone for Patients Undergoing Mitral Valve Replacement Surgery

A Phase 2/3 study testing Inhaled Milrinone and IV Milrinone in people with Mitral Valve Replacement and Pulmonary Hypertension, run by Menoufia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Inhaled Milrinone and IV Milrinone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Apr 2023to 1 Jan 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • Patients with aortic valvular lesions or pulmonary stenosis.
  • Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
  • Contraindication to transesophageal echocardiography; esophageal stricture, tumor or diverticulum or active upper gastrointestinal bleeding
  • Patients with hepatic or renal dysfunction.
  • Patients with coagulopathy.
  • Emergency surgeries.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Menoufia University Hospitals

    Shibīn al Kawm, Menoufia

Other trials in Egypt

About this study

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,

Read more
  • 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.

Read the detailed description

All patients underwent standard preoperative cardiac surgery assessment. Premedication included bromazepam and ranitidine, given the night before and 2 hours prior to arrival to OT. On arrival, IV access and arterial cannula were inserted under local anesthesia, along with routine monitoring electrocardiogram (ECG), pulse oximetery (SpO2), and IBP.

Anesthesia was induced with midazolam, fentanyl, and cis-atracurium. After tracheal intubation, ultrasound (US) guided- central venous catheter (CVC) was inserted and TEE also applied and then anesthesia maintained with morphine, cis-atracurium infusions, and sevoflurane. Mechanical ventilation was set to maintain end-tidal carbon dioxide (etco2) in the range of 30-40 mmHg using lung protective ventilation strategies.

During CPB, flow of 2.2 L.min-1.m-2, a custodiol cardioplegia was given, temperature kept at 28-32℃ and anesthesia maintained by sevoflurane- through a vaporizer mounted on CPB machine-.

A senior consultant certified cardiac anesthetist conducted a baseline TEE using Philips EPIQ CVxi echocardiography machine. Baseline measures included left ventricular ejection fraction (LVEF), and RV function represented by tricuspid annulus plane systolic excursion (TAPSE), fractional area changes (FAC), and right ventricular systolic pressure (RVSP) by doppler also, PVR and systemic vascular resistance (SVR) was calculated, plus patients hemodynamics (mean arterial blood pressure (MAP), heart rate (HR)), all measures were recorded.

Being tested
Inhaled Milrinone, IV Milrinone
Keywords
Milrinone, Pulmonary Hypertension
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled MilrinoneDrug

    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.

  • IV MilrinoneDrug

    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.

Study groups in NCT05838846
Study groupRoleWhat they receive
Group A (iMil)ExperimentalPatients 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. Then pulmonary vascular resistance and systemic vascular resistance will be calculated after first dose ended by 2 minutes and after second dose ended by 15 minutes till stabilization of post CPB other variables like temperature and acid-base status, both measurements will be done while using inspired oxygen of 0.80.
Receives: Drug: Inhaled Milrinone
Group B (IvMil)Active comparatorPatients will receive intravenous milrinone - started after induction of anesthesia - infusion at dosage of 0.3 - 0.75 mcg/kg/min after loading dose of 50 mic/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.
Receives: Drug: IV Milrinone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pulmonary artery pressure

    Measured: Intraoperative

Secondary outcomes (7)

  1. Incidence of systemic hypotension

    Measured: Intraoperative

  2. Hemodynamic affection and need of vasopressors and inotropes.

    Measured: Intraoperative

  3. Pulmonary vascular resistance versus systemic vascular resistance

    Systemic vascular resistance: (MAP-CVP) x 80 / CO

    Pulmonary vascular resistance = (MPAP-PAWP) X 80 / CO

    Measured: Intraoperative

  4. Right ventricular function

    Measured by tricuspid annulus plane systolic excursion, fractional area changes, and right ventricular systolic pressure by doppler

    Measured: Intraoperative

  5. Duration of mechanical ventilation

    Measured: Postoperative in ICU (up to 24 hours)

  6. Need for mechanical circulatory support devices

    Measured: Intraoperative

  7. Urine output

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838846
Sponsor's protocol ID
2/2023 ANET 60
Status last verified
Jan 2025
First submitted
6 Apr 2023
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Inhaled Milrinone and IV Milrinone in people with Mitral Valve Replacement and Pulmonary Hypertension, run by Menoufia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pulmonary artery pressure (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05838846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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