An observational study in Covid 19, sponsored by Methodist Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.
Sponsored by Methodist Health System · Observational
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC.
Glucocorticoids have become standard of care for critical COVID-19 patients, with a mortality benefit shown in several recent randomized control trials. Critical COVID-19 can lead to ARDS, in which the use of glucocorticoids has uncertain benefit beyond 10 days. Studies have shown increased harm in the use of these agents in persistent ARDS (≥14 days). Additionally, studies supporting the use of steroids in COVID-19 only used steroids for a limited time (up to 10 days). Given that these agents can possibly lead to increased patient morbidity and mortality, prolonged use of glucocorticoids is not without risk. To date, there have been no studies evaluating the clinical impact of glucocorticoid use beyond 10 days for treatment of critical COVID-19.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 400 is above the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a retrospective chart review study limited to only patients meeting inclusion and exclusion criteria. Determination of the clinical impact of corticosteroid dosing will be aided by a larger cohort of patients. We plan to conduct the retrospective chart review of all patients identified during the study period 08/01/2020 to 01/31/2021 that meet inclusion and exclusion criteria.
Exclusion Criteria:
All-cause in-hospital mortality at 28 days
All-cause in-hospital mortality at 28 days
Time frame: 28 days
Bacteremia
growth of a pathogenic organism in 1 of 4 blood culture sites; blood cultures are considered contaminants if 1 of 4 sets grows a typically non-pathogenic organism or if the clinical team determines the organism a contaminant. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Time frame: 28 days
Mechanical ventilator-free days
number of days alive and breathing without assistance
Time frame: 28 days
ICU LOS
number of days alive and admitted to the ICU
Time frame: 28 days
Hospital LOS
number of days alive and admitted to MDMC
Time frame: 28 days
hospital acquired pneumonia (HAP)
New lung infiltrate after 48 hrs of admission, positive respiratory culture, AND clinical evidence suggestive of new infection. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Time frame: 28 days
ventilator-associated pneumonia (VAP)
VAP arises \>48 hrs after intubation. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Time frame: 28 days
C. diff infection (CDI)
Acute onset of diarrhea (\> 3 unformed or watery stools occurring in \< 24 hours) AND positive test for toxigenic C. difficile or pseudomembranous colitis on endoscopy OR high clinical suspicion. To determine if the use of corticosteroids beyond 10 days increases the incidence of secondary infection or impacts duration of MV and length of stay in critical COVID-19.
Time frame: 28 days
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Methodist Health System