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临床试验/NCT04838106
NCT04838106进行中(未招募)不适用

Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19)

University of Oxford1 个研究点 分布在 1 个国家目标入组 319,600 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
319,600
试验地点
1
主要终点
Mortality Rate

研究概览

简要总结

This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.

详细描述

Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital.

This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 years or over
  • Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
  • Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-

排除标准

  • Patients who died in hospital after treatment on an ICU

结局指标

主要结局

Mortality Rate

时间窗: One year

Mortality after discharge from hospital

次要结局

  • Rate of development of end stage renal failure(one year)
  • Rate of emergency hospital admission for a major adverse cardiac event(one year)
  • Rate of emergency hospital admission(one year)
  • Rate of emergency hospital admission for respiratory infection(one year)
  • Rate of emergency hospital admission for a venous thrombotic event(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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