European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,995
- 试验地点
- 1
- 主要终点
- Number of patients admitted with confirmed COVID19 infection
研究概览
简要总结
COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Despite the support provided, outcomes are poor, particularly in ventilated patients.
Many unanswered questions remain regarding the pathophysiology of COVID-19, particularly in severely ill patients. No evidence-based treatment is currently available, yet different often experimental therapies are administered to patients.
As experience grows, new phenotypes are recognized, and unreported complications are observed in the most severely ill patients. Although many registries are currently including patients, few of them focus on ICU patients and their specific treatments and newly observed complications and challenges.
Although the pandemic may appear on its return in many countries that are now easing the restrictions that were put in place to limit the spread of the disease, it can be expected that COVID-19 will be a continued challenge in ICUs globally until a safe and effective vaccine is found. Efforts to study the disease should continue in order to advance our understanding of the disease as well as improve treatment options.
详细描述
This is a multicenter, international, anonymized point prevalence study. Patients who were present in the ICU on the day in April 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until July 2020. Retrospective data collection and entry is allowed.
Subjects believed to fulfill all eligibility criteria, and none of the exclusion criteria, detailed in the relevant section of this protocol, will be included in the study.
Data will be entered in the database anonymously.
Data will consist of two core elements:
- Center data (to be completed once)
- Patient data
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is present in an ICU or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit. The exact date can be decided by the local investigator.
- •COVID-19 confirmed diagnosis through PCR or equivalent diagnostic technique
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study: SARS-CoV2 positive without COVID-19
结局指标
主要结局
Number of patients admitted with confirmed COVID19 infection
时间窗: One day with 60 day follow-up
Number of patients in the ICU on the study day
Mortality (ICU)
时间窗: One day with 60 day follow-up
Proportion of patients who have died at ICU discharge
Mortality (60-day)
时间窗: One day with 60 day follow-up
Proportion of patients who have died at day 60
次要结局
- Duration of hospitalization in the ICU(One day with 60 day follow-up)
- Proportion of patients requiring invasive mechanical ventilation(One day with 60 day follow-up)
- Proportion of patients developing infections during ICU stay(One day with 60 day follow-up)
- Proportion of patients developing thromboembolic events during ICU stay(One day with 60 day follow-up)
- Proportion of patients requiring tracheotomy during ICU stay(One day with 60 day follow-up)