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MIX-ECMO: The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients

Sponsor
Semmelweis University Heart and Vascular Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05838937
Collaborator
I.Medizinische Klinik, Universitätsklinikum Mannheim (Other), University Hospital, Limoges (Other)
100
Enrollment
1
Location
21.1
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. Subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. It is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Usefulness of Myocardial Work IndeX in ExtraCorporeal Membrane Oxygenation Patients
    Actual Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Investigation cohort

    Cardiogenic shock patients from any cause receiving veno-arterial extracorporeal membrane oxygenation

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [30 days]

      Death from any cause during the study period

    Secondary Outcome Measures

    1. Cardiovascular mortality, need for long-term mechanical circulatory support or heart transplantation [30 days]

      The total number of patients who die from cardiovascular cause, orrequire for transition to long-term mechanical circulatory support (LVAD/BiVAD), or heart transplantation

    2. Need for renal replacement therapy [30 days]

      The total number of patients who need for renal replacement therapy during intensive care

    3. Successful weaning from mechanical ventilation [30 days]

      The total number of patients who can be successfully weaned from invasive mechanical ventilation

    4. Discharge from intensive care unit [30 days]

      The total number of patients who are discharged from intensive care unit

    5. Discharge from hospital [30 days]

      The total number of patients who are discharged from hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years or older age

    • Severe cardiogenic shock requiring the initiation of VA-ECMO therapy

    • Stabile hemodynamic state and oxigenation with VA-ECMO support

    • Informed written consent (due to the nature of the study, from a legally eligible relative of the patient)

    Exclusion Criteria:

    • Younger than 18 years of age

    • Unstable hemodynamic state or suboptimal oxigenation despite established VA-ECMO support

    • Transesophageal echocardiography is contraindicated

    • Suboptimal echocardiographic window

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Semmelweis University Heart and Vascular Center Budapest BP Hungary 1122

    Sponsors and Collaborators

    • Semmelweis University Heart and Vascular Center
    • I.Medizinische Klinik, Universitätsklinikum Mannheim
    • University Hospital, Limoges

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Balint Karoly Lakatos, Assistant Professor, Semmelweis University Heart and Vascular Center
    ClinicalTrials.gov Identifier:
    NCT05838937
    Other Study ID Numbers:
    • BMEÜ/4229- 1 /2022/EKU
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Balint Karoly Lakatos, Assistant Professor, Semmelweis University Heart and Vascular Center
    Echocardiography
    Myocardial work index
    Cardiogenic shock
    Extracorporeal Membrane Oxygenation Therapy
    Additional relevant MeSH terms:
    Shock, Cardiogenic
    Heart Failure

    Study Results

    No Results Posted as of May 3, 2023