Clinical Features of Severe Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mechanical ventilation duration
研究概览
简要总结
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
详细描述
The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2 virus, and to describe the clinical features of patients admitted to an ICU of the COVID-center of the Federal Research Clinical Center of Federal Medical & Biological Agency on the first day and in dynamics till discharge from the ICU or death.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed.
This study is singlecentral observational trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation
排除标准
- •less than 24 hours in ICU by any reason,
- •chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure),
- •atonic coma.
结局指标
主要结局
Mechanical ventilation duration
时间窗: 30 days
The amount of mechanical ventilation days
Non-invasive Mechanical ventilation duration
时间窗: 30 days
The amount of Non-invasive mechanical ventilation days
Mortality
时间窗: 60 days
The dead and survived patients ratio
次要结局
- Сomplete blood count dynamics(Change from baseline on day 15 during ICU treatment)
- Biochemistry analysis(Change from baseline on day 5 during ICU treatment)
- Vitamin D level dynamics(Change from baseline on day 15 during ICU treatment)
- Immunogram dynamics(Change from baseline on day 15 during ICU treatment)
- Сomplete blood count(Change from baseline on day 5 during ICU treatment)
- Computer tomography(Change from baseline on day 5 during ICU treatment)
- High-sensitive troponin Т(Change from baseline on day 5 during ICU treatment)
- Immunogram(Change from baseline on day 5 during ICU treatment)
- Biochemistry analysis dynamics(Change from baseline on day 15 during ICU treatment)
- Vitamin D level(Change from baseline on day 5 during ICU treatment)
- High-sensitive troponin Т dynamics(Change from baseline on day 15 during ICU treatment)