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Clinical Trials/NCT04838106
NCT04838106
Active, not recruiting
Not Applicable

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 site in 1 country319,600 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
University of Oxford
Enrollment
319600
Locations
1
Primary Endpoint
Mortality Rate
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
February 28, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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-

Exclusion Criteria

  • Patients who died in hospital after treatment on an ICU

Outcomes

Primary Outcomes

Mortality Rate

Time Frame: One year

Mortality after discharge from hospital

Secondary Outcomes

  • 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)

Study Sites (1)

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