Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772586
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Murielle Surquin, Brugmann University Hospital

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
Sarcopenia

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 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 : September 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022



Primary Outcome Measures :
  1. Indication of mechanical ventilation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion, an average of 60 days ]
    Vital status during hospital admission, at 30- and 60-day follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 60 and older admitted in an acute care unit of Brugmann university hospital due to COVID-19
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772586


Contacts
Layout table for location contacts
Contact: Murielle Surquin 003202 477 21 11 ext 72386 Murielle.SURQUIN@chu-brugmann.be
Contact: Maria Dolores SANCHEZ-RODRIGUEZ 003202 477 21 11 ext 54540 DoloresMaria.SANCHEZ-RODRIGUEZ@chu-brugmann.be

Locations
Layout table for location information
Belgium
Brugmann university hospital Recruiting
Brussels, Belgium, 1020
Contact: Murielle Surquin    02 477 21 11 ext 72386    Murielle.SURQUIN@chu-brugmann.be   
Contact: Dolores Sanchez-Rodriguez    02 477 21 11 ext 54540    DoloresMaria.SANCHEZ-RODRIGUEZ@chu-brugmann.be   
Sponsors and Collaborators
Brugmann University Hospital
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Murielle Surquin, Prof Dr Murielle Surquin MD PhD, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT04772586    
Other Study ID Numbers: SARCO-V_2021/110
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murielle Surquin, Brugmann University Hospital:
Sarcopenia
Mechanical ventilation
Older patients
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical