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| ID | Type | Description | Link |
|---|---|---|---|
| 21/SC/0021 | Other Identifier | South Central - Hampshire B Research Ethics Committee | |
| 21/CAG/0017 | Other Identifier | Confidentiality Advisory Group |
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| Name | Class |
|---|---|
| Intensive Care National Audit & Research Centre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable as observational study | Other | Not applicable as observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | Mortality after discharge from hospital | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of emergency hospital admission | Emergency hospital admission | one year |
| Rate of emergency hospital admission for respiratory infection | Emergency hospital admission for respiratory infection |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Watkinson, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
Individual participant data will not be made publicly available due to privacy and legal implications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2022 | Aug 9, 2022 |
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| one year |
| 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 |
| 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 |
| Rate of development of end stage renal failure | Development of end stage renal failure treated by renal replacement therapy | one year |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2023 | Jun 19, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D016638 | Critical Illness |
| D006333 | Heart Failure |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D004617 | Embolism |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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