Sarcopenia and Mechanical Ventilation in Older Patients Admitted Due to COVID-19 (SARCO-V)
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|ClinicalTrials.gov Identifier: NCT04772586|
Recruitment Status : Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
- 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).
- 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)
- 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
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
|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|