SARCO-V: Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19

Sponsor
Brugmann University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04772586
Collaborator
(none)
46
1
11.6
4

Study Details

Study Description

Brief Summary

The SarcoV study aims at assessing the association between sarcopenia and the indication of mechanical ventilation in older hospitalized patients due to COVID-19 infection

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Sarcopenia is disease associated with poor clinical outcomes. In critical ill chirurgical patients, sarcopenia is associated with difficult to wean of mechanical ventilation. The association between sarcopenia and mechanical ventilation is poorly studied in medical patients. COVID-19 pandemic has led a lot of medical patient to be admitted in intensive care units due to acute respiratory failure with need of mechanical ventilation support.

    The primary objective is to determine if sarcopenia in critically-ill older patients with COVID-19 is associated with the indication of mechanical ventilation. Secondarily, the study aims at determining if sarcopenia is associated with difficult to wean and mortality in critically-ill older patients with COVID-19.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    46 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Sarcopenia and Mechanical Ventilation in Older Patient Admitted With COVID-19 Infection
    Actual Study Start Date :
    Sep 1, 2020
    Actual Primary Completion Date :
    Aug 20, 2021
    Actual Study Completion Date :
    Aug 20, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Indication of mechanical ventilation [Through study completion, an average of 60 days]

      Association between probable sarcopenia and the indication of mechanical ventilation in patients with COVID-19 infection. Mechanical ventilation was considered by non-invasive ventilation or invasive ventilation. For purpose of analysis, it was defined as a binary outcome (yes(no). Probable sarcopenia probable was defined according to the revised European consensus on definition and diagnosis of sarcopenia (EWGSOP2). For purpose of analysis, it was defined as a binary condition (yes/no).

    Secondary Outcome Measures

    1. Evaluate difficult-to-wean in mechanical ventilation [Through study completion, an average of 60 days]

      Difficult to wean in mechanical ventilation is defined if the patient required more than 7 days of mechanical ventilation from the first spontaneous breath test or if the patient was reintubated within 48 hours after extubation. For purpose of analysis, it was considered as a binary outcome (yes/no)

    2. All-cause mortality [Through study completion, an average of 60 days]

      Vital status during hospital admission, at 30- and 60-day follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • Consecutive patients aged 60 and older

    • Admission in an acute care unit in Brugmann university hospital due to a COVID-19 possible or confirmed infection. A infection was considered confirmed in presence of a positive molecular test by Polymerase-chain reaction (PCR), following the Belgian Public Health Department recommendations (Sciensano recommendations).

    Exclusion criteria

    • Patients unable to perform a grip-strength measurement due to any rheumatological or neurological condition.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brugmann university hospital Brussels Belgium 1020

    Sponsors and Collaborators

    • Brugmann University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Murielle Surquin, Prof Dr Murielle Surquin MD PhD, Brugmann University Hospital
    ClinicalTrials.gov Identifier:
    NCT04772586
    Other Study ID Numbers:
    • SARCO-V_2020/110
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Murielle Surquin, Prof Dr Murielle Surquin MD PhD, Brugmann University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022