- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407156
Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom
September 8, 2020 updated by: University Hospitals of Derby and Burton NHS Foundation Trust
Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom
Severe Acute respiratory syndrome coronovirus (SARS-CoV-2) was first described in Wuhan in December 2019.
It quickly spread to rest of the world and was declared pandemic by World health organisation.
Initial case series focused on lung involvement in the form alveolar haemorrhages and respiratory failure.
However, subsequently, there have been reports of kidney involvement resulting in severe acute kidney injury.
However, the reported incidence from Chinese data has been less than 5% and detailed epidemiology of AKI in COVID-19 disease is lacking.
Study Overview
Detailed Description
On 31st December 2019, a cluster of pneumonia cases were detected in Hubei province of China where the cause was unclear.
The cause for these cases was subsequently identified as a virus which was referred to as SARS-CoV-2, and the associated disease as COVID-19.This evolved rapidly into a global pandemic with first case reported in UK as early as on 30th January 2020.
As of 30th April 2020, there have been 3.05 million laboratory confirmed cases world-wide with 161,145 cases in United Kingdom (UK) in 539,768 cases tested for COVID-19.
The epidemiology of COVID-19 has differed in China, US and Italy which have different demographic characteristics, testing methods and different ways to curb the spread of infection which can be altered by many things, including behaviour, and the stringent social distancing measure.Though the pandemic started in China, as of 30th April 2020, it has reported only 58.32 cases per million people (pmp) as compared to United kingdom which has reported 2433.8 cases pmp.
This has resulted in different epidemiology of COVID-19 and organ system involvement.
Lung involvement in the form of alveolar haemorrhages and respiratory failure has been well document in patients with COVID-19 and has been focus of attention, however, other organs are also affected in COVID-19, but there has been limited information kidney involvement in COVID patients.
Study Type
Observational
Enrollment (Actual)
724
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Derbyshire
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Derby, Derbyshire, United Kingdom, DE22 3NE
- Derby Hospital NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population is hospitalised patients suspected to have SARS CoV-2 infection
Description
Inclusion Criteria:
All patients who are admitted to the hospital with suspected COVID-19 infection between 1st March 2020 and 8th May 2020 and who meet following criteria will be included
- Adult patients greater or equal to 18 years of age.
- Swab results available for SARS CoV-19
- Patients admitted to the hospital as per the national screening criteria
Exclusion Criteria:
The following patients will be excluded from the study
- Paediatric patients as defined by age of <18 years of age
- Swab results which are awaited
- Patients on haemodialysis or peritoneal dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Acute kidney injury in COVID-19
Time Frame: 7 days
|
This is the proportion of patients with Acute kidney injury in COVID-19
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality in AKI patients
Time Frame: 7 days
|
This is the number of deaths in COVID-19 AKI patients
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nitin V Kolhe, MD, University Hospitals of Derby and Burton
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
June 7, 2020
Study Completion (Actual)
July 20, 2020
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 8, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHDB/2020/050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The results will be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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