Clinical trial NCT04772586: Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19
Official title: Sarcopenia and Mechanical Ventilation in Older Patient Admitted With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: Sarcopenia
Mechanical ventilation
Older patients
COVID-19
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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.

Primary outcomes:
measure: Indication of mechanical ventilation
timeFrame: Through study completion, an average of 60 days
Secondary outcomes:
measure: Evaluate difficult-to-wean in mechanical ventilation
timeFrame: Through study completion, an average of 60 days
measure: All-cause mortality
timeFrame: Through study completion, an average of 60 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brugmann university hospital
Study officials:
References:
citation: Kou HW, Yeh CH, Tsai HI, Hsu CC, Hsieh YC, Chen WT, Cheng HT, Yu MC, Lee CW. Sarcopenia is an effective predictor of difficult-to-wean and mortality among critically ill surgical patients. PLoS One. 2019 Aug 8;14(8):e0220699. doi: 10.1371/journal.pone.0220699. eCollection 2019.
citation: Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.