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Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04838106
Acronym
OPTIC-19
Enrollment
319600
Registered
2021-04-08
Start date
2020-08-01
Completion date
2025-02-28
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Critical Illness, Deep Vein Thrombosis, Heart Failure, Myocardial Infarction, Pulmonary Embolism, Renal Failure, Stroke

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.

Interventions

Not applicable as observational study.

Sponsors

Intensive Care National Audit & Research Centre
CollaboratorOTHER
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality RateOne yearMortality after discharge from hospital

Secondary

MeasureTime frameDescription
Rate of emergency hospital admissionone yearEmergency hospital admission
Rate of emergency hospital admission for respiratory infectionone yearEmergency hospital admission for respiratory infection
Rate of emergency hospital admission for a major adverse cardiac eventone yearEmergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure)
Rate of emergency hospital admission for a venous thrombotic eventone yearEmergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism)
Rate of development of end stage renal failureone yearDevelopment of end stage renal failure treated by renal replacement therapy

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026