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

Sponsor

University of Oxford (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04838106

Collaborator

Intensive Care National Audit & Research Centre (Other)

319,600

Enrollment

Location

Anticipated Duration (Months)

13344.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Myocardial Infarction Stroke Critical Illness Heart Failure Deep Vein Thrombosis Pulmonary Embolism Renal Failure	Other: Not applicable as observational study

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

319600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Covid19 Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020.	Other: Not applicable as observational study Not applicable as observational study.
Non Covid19 Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020.	Other: Not applicable as observational study Not applicable as observational study.

Arm

Intervention/Treatment

Covid19

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020.

Other: Not applicable as observational study

Not applicable as observational study.

Non Covid19

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020.

Other: Not applicable as observational study

Not applicable as observational study.

Outcome Measures

Primary Outcome Measures

Mortality Rate [One year]
Mortality after discharge from hospital

Secondary Outcome Measures

Rate of emergency hospital admission [one year]
Emergency hospital admission
Rate of emergency hospital admission for respiratory infection [one year]
Emergency hospital admission for respiratory infection
Rate of emergency hospital admission for a major adverse cardiac event [one year]
Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure)
Rate of emergency hospital admission for a venous thrombotic event [one year]
Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism)
Rate of development of end stage renal failure [one year]
Development of end stage renal failure treated by renal replacement therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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-