Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- All-cause in-hospital mortality at 28 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •ICU admission at any time during first hospital admission for COVID-19
- •COVID-19 diagnosis
- •Dexamethasone, hydrocortisone, or methylprednisolone therapy for SARS-CoV-2 infection
排除标准
- •Prior ICU admission before study start date
- •Death or hospice before day 11 of hospital admission
- •Still admitted at time of data analysis from index admission
结局指标
主要结局
All-cause in-hospital mortality at 28 days
时间窗: 28 days
All-cause in-hospital mortality at 28 days
次要结局
- hospital acquired pneumonia (HAP)(28 days)
- ventilator-associated pneumonia (VAP)(28 days)
- Mechanical ventilator-free days(28 days)
- Hospital LOS(28 days)
- Bacteremia(28 days)
- ICU LOS(28 days)
- C. diff infection (CDI)(28 days)
