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HEMOCARD: The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05752383
Collaborator
(none)
500
Enrollment
1
Location
71.3
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.

This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.

The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care
    Actual Study Start Date :
    Jan 24, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2028
    Anticipated Study Completion Date :
    Jan 1, 2029

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of in-hospital mortality after cardiogenic shock [5 years]

    2. Vaso-inotropic score after cardiogenic shock [5 years]

      vasoactive-inotropic score (VIS) Maximal VIS (VISmax) is calculated using the highest doses of vasoactive and inotropic medications administered. VISmax categories: 0-5, >5-15, >15-30, >30-45, and >45 points.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients hospitalized in ICU for cardiogenic shock

    • Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

    Exclusion Criteria:
    • Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Picardie Amiens France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05752383
    Other Study ID Numbers:
    • PI2022_843_0132
    First Posted:
    Mar 2, 2023
    Last Update Posted:
    Mar 2, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Cardiogenic Shock
    vaso-inotropic score
    Additional relevant MeSH terms:
    Shock, Cardiogenic
    Shock

    Study Results

    No Results Posted as of Mar 2, 2023