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Epidemiology of Acute Kidney Injury in COVID19 Disease in United Kingdom

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407156
Recruitment Status : Completed
First Posted : May 29, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospitals of Derby and Burton NHS Foundation Trust

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
COVID AKI Other: acute kidney injury

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 Design
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Study Type : Observational
Actual Enrollment : 724 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Acute Kidney Injury In Corona Virus Infection Disease (COVID19) in United Kingdom
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : June 7, 2020
Actual Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: acute kidney injury
    AKI in COVID positive cases

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All-cause mortality in AKI patients [ Time Frame: 7 days ]
    This is the number of deaths in COVID-19 AKI patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is hospitalised patients suspected to have SARS CoV-2 infection
Criteria

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

  1. Adult patients greater or equal to 18 years of age.
  2. Swab results available for SARS CoV-19
  3. Patients admitted to the hospital as per the national screening criteria

Exclusion Criteria:

The following patients will be excluded from the study

  1. Paediatric patients as defined by age of <18 years of age
  2. Swab results which are awaited
  3. Patients on haemodialysis or peritoneal dialysis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407156


Locations
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United Kingdom
Derby Hospital NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3NE
Sponsors and Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
Investigators
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Principal Investigator: Nitin V Kolhe, MD University Hospitals of Derby and Burton
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospitals of Derby and Burton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04407156    
Other Study ID Numbers: UHDB/2020/050
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The results will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases