Regional COVID Epidemiology in England (RECEDE)

• Conditions: Acute Kidney Injury
• Interventions: Other: No intervention

• Registration Number: NCT04579562
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Study Start: 2020-11-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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

1. Diagnostic code for COVID-19 (U07.1) in any of the 20 diagnoses codes
2. 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

1. Diagnostic code for AKI (N17) in any of the 20 diagnoses codes
2. Adult patients greater or equal to 18 years of age.

Exclusion Criteria

WP1:

The following patients will be excluded from the study

1. Patients not admitted to the hospital
2. Paediatric patients < 18 years of age

WP2:

The following patients will be excluded from the study

1. Patients not admitted to the hospital
2. Paediatric patients < 18 years of age
3. Patients on chronic maintenance haemodialysis or peritoneal dialysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID negative AKI	No intervention	-
COVID-19 positive AKI	No intervention	-
COVID-19 positive no AKI	No intervention	-

Primary Outcome Measures

Name	Time	Method
acute kidney injury	30 days	Incidence of acute kidney injury in patients with COVID-19
All-cause mortality	30 days	In-hospital all cause mortality in patients with acute kidney injury and COVID-19

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation	30 days	Need for mechanical ventilation in patients with COVID-19