Regional COVID Epidemiology in England (RECEDE)

Acute Kidney Injury Clinical Trial

— RECEDE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04579562
• Other study ID #: UHDB/2020/075
• Status: Not yet recruiting
• Start date: November 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: October 2020
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: Nitin V Kolhe, DM
• Phone: 01332788266
• Email: nitin.kolhe[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: October 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• No intervention
This is observational, non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	In-hospital all cause mortality in patients with acute kidney injury and COVID-19	30 days
Primary	acute kidney injury	Incidence of acute kidney injury in patients with COVID-19	30 days
Secondary	Mechanical ventilation	Need for mechanical ventilation in patients with COVID-19	30 days