Acute Kidney InjuryRECEDENCT04579562
Regional COVID Epidemiology in England (RECEDE)
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will use analysis of all admitted patients in the past in England between 1st March 2020 and 30th June 2020 from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions at NHS hospitals in England. This design will help to analyse large number of AKI patients in short time-span so as to cascade the learning in timely fashion. HES collects a detailed record for each admitted patient care delivered in England, either by NHS hospitals. In each patient record, there are specific codes for additional diagnosis, or operations. We will extract all patients with diagnosis of COVID-19 by ICD-10 code of U07.1 and AKI as identified by ICD-10 code of N17 in any of the 20 diagnostic codes during the study period.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patients not admitted to the hospital
- Paediatric patients < 18 years of age
- Patients on chronic maintenance haemodialysis or peritoneal dialysis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Regional Epidemiology of COVID-19 and Acute Kidney Injury in England
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.
- Conditions
- Acute Kidney Injury
- Being tested
- No intervention
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is observational, non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive AKI | Not described Receives: Other: No intervention | |
| COVID-19 positive no AKI | Not described Receives: Other: No intervention | |
| COVID negative AKI | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
In-hospital all cause mortality in patients with acute kidney injury and COVID-19
Measured: 30 days
acute kidney injury
Incidence of acute kidney injury in patients with COVID-19
Measured: 30 days
Secondary outcomes (1)
Mechanical ventilation
Need for mechanical ventilation in patients with COVID-19
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579562
- Sponsor's protocol ID
- UHDB/2020/075
- Acronym
- RECEDE
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kolhe NV, Fluck R, Taal M. Effect of COVID-19 with or without acute kidney injury on inpatient mortality in England: a national observational study using administrative data. BMJ Open. 2025 Mar 15;15(3):e095020. doi: 10.1136/bmjopen-2024-095020.
PubMed 40090681Kolhe NV, Fluck RJ, Taal MW. Regional variation of COVID-19 admissions, acute kidney injury and mortality in England - a national observational study using administrative data. BMC Infect Dis. 2024 Mar 22;24(1):346. doi: 10.1186/s12879-024-09210-6.
PubMed 38519921
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Epidemiology of COVID-19 and Acute Kidney Injury in England
- ClinicalTrials.gov ID
- NCT04579562
- Acronym / sponsor ID
- RECEDE / UHDB/2020/075
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive AKI | – | Other: No intervention |
| COVID-19 positive no AKI | – | Other: No intervention |
| COVID negative AKI | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will use analysis of all admitted patients in the past in England between 1st March 2020 and 30th June 2020 from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions at NHS hospitals in England. This design will help to analyse large number of AKI patients in short time-span so as to cascade the learning in timely fashion. HES collects a detailed record for each admitted patient care delivered in England, either by NHS hospitals. In each patient record, there are specific codes for additional diagnosis, or operations. We will extract all patients with diagnosis of COVID-19 by ICD-10 code of U07.1 and AKI as identified by ICD-10 code of N17 in any of the 20 diagnostic codes during the study period.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- The following patients will be excluded from the study
- Patients not admitted to the hospital
- Paediatric patients < 18 years of age
- The following patients will be excluded from the study
- Patients not admitted to the hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is observational, non-interventional study | Other | COVID negative AKI, COVID-19 positive AKI, COVID-19 positive no AKI |
Primary outcome
All-cause mortality
Time frame: 30 days
In-hospital all cause mortality in patients with acute kidney injury and COVID-19
acute kidney injury
Time frame: 30 days
Incidence of acute kidney injury in patients with COVID-19
1 secondary outcome
Mechanical ventilation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 40090681Kolhe NV, Fluck R, Taal M. Effect of COVID-19 with or without acute kidney injury on inpatient mortality in England: a national observational study using administrative data. BMJ Open. 2025 Mar 15;15(3):e095020. doi: 10.1136/bmjopen-2024-095020.
- Derived from this study: PubMed 38519921Kolhe NV, Fluck RJ, Taal MW. Regional variation of COVID-19 admissions, acute kidney injury and mortality in England - a national observational study using administrative data. BMC Infect Dis. 2024 Mar 22;24(1):346. doi: 10.1186/s12879-024-09210-6.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitin V Kolhe, DM (01332788266, nitin.kolhe@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.