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临床试验/NCT05595031
NCT05595031招募中不适用

Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 Acute Respiratory Distress Syndrome

Methodist Health System1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年10月19日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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