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

Stroke Clinical Trial

— OPTIC-19  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04838106
• Other study ID #: PID15456
• Secondary ID: 21/SC/002121/CAG
• Status: Active, not recruiting
• Start date: August 1, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 319600
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Critical Illness
• Deep Vein Thrombosis
• Embolism
• Heart Failure
• Infarction
• Myocardial Infarction
• Pulmonary Embolism
• Renal Failure
• Stroke
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Not applicable as observational study
Not applicable as observational study.

Locations

Country	Name	City	State
United Kingdom	Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Intensive Care National Audit & Research Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate	Mortality after discharge from hospital	One year
Secondary	Rate of emergency hospital admission	Emergency hospital admission	one year
Secondary	Rate of emergency hospital admission for respiratory infection	Emergency hospital admission for respiratory infection	one year
Secondary	Rate of emergency hospital admission for a major adverse cardiac event	Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure)	one year
Secondary	Rate of emergency hospital admission for a venous thrombotic event	Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism)	one year
Secondary	Rate of development of end stage renal failure	Development of end stage renal failure treated by renal replacement therapy	one year