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

Active, not recruiting

• Conditions: Myocardial Infarction; Critical Illness; Pulmonary Embolism; Stroke; Deep Vein Thrombosis; Renal Failure; Covid19; Heart Failure
• Interventions: Other: Not applicable as observational study

• Registration Number: NCT04838106
• Lead Sponsor: University of Oxford

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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 319600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid19	Not applicable as observational study	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.
Non Covid19	Not applicable as observational study	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.

Primary Outcome Measures

Name	Time	Method
Mortality Rate	One year	Mortality after discharge from hospital

Secondary Outcome Measures

Name	Time	Method
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	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 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

Trial Locations

Locations (1)

Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom