Regional COVID Epidemiology in England (RECEDE)

Study Overview
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Brief Summary
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The COVID-19 pandemic has exposed the unwanted variation in outcomes as evidence by Public Health England's report on increased mortality in regions of the country. For example, UHDB, in East Midlands, has reported a high crude mortality as compared to other Trusts in the region.8 There may also have been variation in the incidence of complications of COVID-19 in the form of AKI, which may have influenced mortality. Variation in outcomes may be because of various factors - differing population demographics, underlying health conditions in the population, deprivation, physician preference and knowledge and ethnic diversity. Unwanted variation is care that is not consistent with a patient's preference or related to [their] underlying illness. It is important to understand the reason for unwanted variation in outcomes associated with COVID-19 to minimise patient harm and reduce morbidity and mortality.

Official Title
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Regional Epidemiology of COVID-19 and Acute Kidney Injury in England

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will have two work packages (WP). Work Package 1 (WP1): Regional epidemiology of COVID-19 in England All patients who are admitted to hospital with COVID-19 infection between 1st March 2020 and 30th June 2020 and who meet following criteria will be included Diagnostic code for COVID-19 (U07.1) in any of the 20 diagnoses codes Adult patients greater or equal to 18 years of age. Work Package 2 (WP2): Epidemiology of COVID-19 associated AKI in England All patients who are admitted to hospital with acute kidney injury (AKI) between 1st March 2020 and 30th June 2020 and who meet following criteria will be included Diagnostic code for AKI (N17) in any of the 20 diagnoses codes Adult patients greater or equal to 18 years of age. Exclusion Criteria: WP1: The following patients will be excluded from the study Patients not admitted to the hospital Paediatric patients < 18 years of age WP2: The following patients will be excluded from the study Patients not admitted to the hospital Paediatric patients < 18 years of age Patients on chronic maintenance haemodialysis or peritoneal dialysis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 positive AKI<br> | Other: No intervention<br>* This is observational, non-interventional study<br>|
| COVID-19 positive no AKI<br> | Other: No intervention<br>* This is observational, non-interventional study<br>|
| COVID negative AKI<br> | Other: No intervention<br>* This is observational, non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | In-hospital all cause mortality in patients with acute kidney injury and COVID-19 | 30 days | 
| acute kidney injury | Incidence of acute kidney injury in patients with COVID-19 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation | Need for mechanical ventilation in patients with COVID-19 | 30 days |