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

Completed

• Conditions: Sarcopenia

• Registration Number: NCT04772586
• Lead Sponsor: 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

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
All-cause mortality	Through study completion, an average of 60 days	Vital status during hospital admission, at 30- and 60-day follow-up

Trial Locations

Locations (1)

Brugmann university hospital; 🇧🇪 Brussels, Belgium