ECMO: Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation.

Sponsor
Hamad Medical Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05730894
Collaborator
(none)
120
1
4
29.7

Study Details

Study Description

Brief Summary

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) support is a lifesaving tool used to treat cardiogenic shock, acute heart failure, or extracorporeal cardiopulmonary resuscitation(CPR). However, its use is associated with significant complications, including mortality. We aim to conduct a retrospective observational study of all patients at Heart Hospital who required VA-ECMO support due to cardiogenic shock during 1/06/2016 and 1/06/2022 to report the incidence of in-hospital mortality among patients who required VA-ECMO along with the predictors of mortality. Data will be collected to identify baseline characteristics and outcomes including clinical variables predictive of poor outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Extracorporeal membrane oxygenation (ECMO) is an advanced life support modality for critically ill patients with refractory cardiac or respiratory failure. It is a temporary support for cardiorespiratory failure, bridging time for recovery or permanent assist. Besides, ECMO could be used in a variety of clinical presentations, such as severe traumas, extracorporeal-assisted rewarming (ECAR) of accidental deep hypothermia, and can be used as a bridge to lung or heart transplant.

    Cardiogenic shock can be a fatal condition with poor prognosis. Conventional treatments for cardiogenic shock include vasopressor agents guided by invasive monitoring, and intraaortic balloon pump support. There has been growing interest in the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as a salvage therapy for patients in cardiogenic shock refractory to conventional treatments. However, there is a low rate of survival to weaning or bridging therapy among patients with cardiogenic shock requiring ECMO (42-56%). Moreover, VA-ECMO use is associated with complications, including bleeding, renal failure. Thus, the benefits of this potentially life-saving support is still subject to discussion, especially for VA-ECMO use in the setting of cardiogenic shock as the evidence is scarce. Therefore, it important to identify the patients' related factors that may be associated with poor outcomes using real-world data. We will conduct a retrospective observational study of all patients at Heart Hospital who required VA-ECMO support due to cardiogenic shock during 1/06/2016 and 1/06/2022 with the aim of quantifying the incidence of in-hospital mortality among patients who required VA-ECMO in the setting of cardiogenic shock along with determining the predictors of mortality.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Predictors of Mortality in Patients With VA-Extracorporeal Membrane Oxygenation. A Retrospective Data Review.
    Anticipated Study Start Date :
    Feb 28, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. mortality [6 months]

      mortality in patients who had VA-ECMO

    Secondary Outcome Measures

    1. bacterial pathogens responsible for infection-related mortality in VA-ECMO [1 month]

      infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Adults with the age of ≥ 18 years

    • Requiring VA-ECMO or VAV-ECMO support

    Exclusion Criteria:
    • Requiring VV-ECMO support

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hamad medical corporation Doha DA Qatar 3050

    Sponsors and Collaborators

    • Hamad Medical Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hamad Medical Corporation
    ClinicalTrials.gov Identifier:
    NCT05730894
    Other Study ID Numbers:
    • MRC-01-22-574
    First Posted:
    Feb 16, 2023
    Last Update Posted:
    Feb 16, 2023
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hamad Medical Corporation

    Study Results

    No Results Posted as of Feb 16, 2023