Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- All-cause in-hospital mortality at 28 days [28 days]
All-cause in-hospital mortality at 28 days
Secondary Outcome Measures
- Bacteremia [28 days]
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.
- Mechanical ventilator-free days [28 days]
number of days alive and breathing without assistance
- ICU LOS [28 days]
number of days alive and admitted to the ICU
- Hospital LOS [28 days]
number of days alive and admitted to MDMC
- hospital acquired pneumonia (HAP) [28 days]
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.
- ventilator-associated pneumonia (VAP) [28 days]
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.
- C. diff infection (CDI) [28 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age
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ICU admission at any time during first hospital admission for COVID-19
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COVID-19 diagnosis
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Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection
Exclusion Criteria:
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Prior ICU admission before study start date
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Death or hospice before day 11 of hospital admission
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Still admitted at time of data analysis from index admission
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Methodist Dallas Medical Center | Dallas | Texas | United States | 75052 |
Sponsors and Collaborators
- Methodist Health System
Investigators
- Principal Investigator: Kristen Rahmanzadeh, PharmD, Methodist Dallas Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 044.PHA.2021.D