Clinical trial NCT04838106: Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Myocardial Infarction
Stroke
Critical Illness
Heart Failure
Deep Vein Thrombosis
Pulmonary Embolism
Renal Failure
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Intensive Care National Audit & Research Centre
First posted: 2021-04-08
Enrollment: 319600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge.

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.

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

Primary outcomes:
measure: Mortality Rate
timeFrame: One year
Secondary outcomes:
measure: Rate of emergency hospital admission
timeFrame: one year
measure: Rate of emergency hospital admission for respiratory infection
timeFrame: one year
measure: Rate of emergency hospital admission for a major adverse cardiac event
timeFrame: one year
measure: Rate of emergency hospital admission for a venous thrombotic event
timeFrame: one year
measure: Rate of development of end stage renal failure
timeFrame: one year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Peter Watkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: