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.
Study Type
OBSERVATIONAL
Enrollment
400
Methodist Dallas Medical Center
Dallas, Texas, United States
RECRUITINGAll-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.
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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