Acute KIDnEy Injury in CoviD-19 (AIDED)

Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)

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).

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3DT
      • University Hospitals of Derby and Burton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People who were admitted to the hospital with COVID-19:

• Group A: people who had COVID-19 with AKI.
• Group B: people who had COVID-19 without AKI.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID AKI; Participants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay.	Other: No intervention; 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.	Other: No intervention; This study does not involve any intervention or new treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of kidney disease progression at 12 months.	Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%	12 months after hospital discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of albuminuria at 6-9 months.	Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.	6-9 months after hospital discharge.
Incidence of albuminuria at 12-15 months.	Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.	12-15 months after hospital discharge.
Incidence of combined kidney disease progression and albuminuria at 6-9 months.	Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).	6-9 months after hospital discharge.
Incidence of combined kidney disease progression and albuminuria at 12-15 months.	Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).	12-15 months after hospital discharge.
Factors associated with all-cause mortality at 6-9 months.	Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality	6-9 months after hospital discharge.
Factors associated with all-cause mortality at 12-15 months.	Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality	12-15 months after hospital discharge.
Incidence of hospital readmissions at 6-9 months	Number of hospital readmissions	6-9 months after hospital discharge.
Incidence of hospital readmissions at 12-15 months	Number of hospital readmissions	12-15 months after hospital discharge.

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Investigators: Principal Investigator: Nitin V Kolhe, Doctor, University Hospitals of Derby and Burton NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: UHDB/2020/076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No