Acute KIDnEy Injury in CoviD-19

NCT ID: NCT04583293

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-08

Study Completion Date

2024-01-25

Brief Summary

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This is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).

Detailed Description

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After the participants have read and understand the PIS, and had sufficient time (at least 24 hours) to consider their participation in this study, the investigators will ask them to sign a consent form, which shows their willingness to take part. The investigators will then collect information from their medical records about their hospital admission with COVID-19, including their age, ethnicity, medical conditions, length of hospital stay, tablets or any other treatments they received, as well as details of their stay in the intensive care unit.

For the two groups - COVID AKI and COVID non-AKI, telephone follow-up with a study questionnaire will be performed at recruitment, 6-9 months and 12-15 months after hospital discharge. The study questionnaire will include the following:

1. Details of any medical event and date of medical event since last study follow-up.
2. Details of any hospital re-admission.
3. Details of current medication.

In addition, at the same time points, participants will be asked to attend their general practitioner surgery or other clinic to have simple clinical measurements (height, weight and blood pressure), blood and urine tests.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID AKI

Participants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay.

No intervention

Intervention Type OTHER

This study does not involve any intervention or new treatment.

COVID non-AKI

Participants who were admitted to the hospital with COVID-19 and did not develop AKI during their hospital stay.

No intervention

Intervention Type OTHER

This study does not involve any intervention or new treatment.

Interventions

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No intervention

This study does not involve any intervention or new treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adult patients greater or equal to 18 years of age.
2. Swab results positive for SARS-CoV-2.
3. Patients admitted to the hospital for ≥24hrs.

Exclusion Criteria

1. Paediatric patients as defined by age of \<18 years of age.
2. Patients \>90 years of age.
3. Swab results negative for SARS-CoV-2.
4. Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2), solid organ transplant.
5. Inability/refusal to give informed consent to participate.
6. Death during the same hospital admission that AKI occurred.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nitin V Kolhe, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Derby and Burton NHS Foundation Trust

Locations

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University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UHDB/2020/076

Identifier Type: -

Identifier Source: org_study_id

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