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

Sarcopenia Clinical Trial

— SARCO-V  

Official title:

Sarcopenia and Mechanical Ventilation in Older Patient Admitted With COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772586
• Other study ID #: SARCO-V_2020/110
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sarcopenia

Locations

Country	Name	City	State
Belgium	Brugmann university hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indication of mechanical ventilation	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).	Through study completion, an average of 60 days
Secondary	Evaluate difficult-to-wean in mechanical ventilation	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)	Through study completion, an average of 60 days
Secondary	All-cause mortality	Vital status during hospital admission, at 30- and 60-day follow-up	Through study completion, an average of 60 days

External Links

•   Definition of a confirmed COVID-19 case and National recommendations for the request of PCR test for COVID-19 in Belgium by the Belgian Public Health Department (Sciensano)