Acute Kidney InjuryAIDEDNCT04583293
Acute KIDnEy Injury in CoviD-19
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2020to 25 Jan 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients greater or equal to 18 years of age.
- Swab results positive for SARS-CoV-2.
- Patients admitted to the hospital for ≥24hrs.
Who cannot join
- Paediatric patients as defined by age of <18 years of age.
- Patients >90 years of age.
- Swab results negative for SARS-CoV-2.
- Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR <15ml/min/1.73m2), solid organ transplant.
- Inability/refusal to give informed consent to participate.
- Death during the same hospital admission that AKI occurred.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT
About this study
Official title: 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).
Read the 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:
- Details of any medical event and date of medical event since last study follow-up.
- Details of any hospital re-admission.
- 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
- 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 study does not involve any intervention or new treatment.
| Study group | Role | What they receive |
|---|---|---|
| COVID AKI | Participants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay. Receives: Other: No intervention | |
| COVID non-AKI | Participants who were admitted to the hospital with COVID-19 and did not develop AKI during their hospital stay. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 12 months after hospital discharge.
Secondary outcomes (8)
Incidence of albuminuria at 6-9 months.
Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 12-15 months after hospital discharge.
Incidence of hospital readmissions at 6-9 months
Number of hospital readmissions
Measured: 6-9 months after hospital discharge.
Incidence of hospital readmissions at 12-15 months
Number of hospital readmissions
Measured: 12-15 months after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start8 Oct 2020
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin V Kolhe, Doctor, Principal investigator, University Hospitals of Derby and Burton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583293
- Sponsor's protocol ID
- UHDB/2020/076
- Acronym
- AIDED
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2020
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04583293
- Acronym / sponsor ID
- AIDED / UHDB/2020/076
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 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.
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
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:
- Details of any medical event and date of medical event since last study follow-up.
- Details of any hospital re-admission.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID AKI | – | Other: No interventionParticipants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay. |
| COVID non-AKI | – | Other: No interventionParticipants who were admitted to the hospital with COVID-19 and did not develop AKI during their hospital stay. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients greater or equal to 18 years of age.
- Swab results positive for SARS-CoV-2.
- Patients admitted to the hospital for ≥24hrs.
Key exclusion criteria (6 listed)
- Paediatric patients as defined by age of <18 years of age.
- Patients >90 years of age.
- Swab results negative for SARS-CoV-2.
- Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR <15ml/min/1.73m2), solid organ transplant.
- Inability/refusal to give informed consent to participate.
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 study does not involve any intervention or new treatment. | Other | COVID AKI, COVID non-AKI |
Primary outcome
Incidence of kidney disease progression at 12 months.
Time frame: 12 months after hospital discharge.
Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%
8 secondary outcomes
Incidence of albuminuria at 6-9 months.
Time frame: 6-9 months after hospital discharge.
Incidence of albuminuria at 12-15 months.
Time frame: 12-15 months after hospital discharge.
Incidence of combined kidney disease progression and albuminuria at 6-9 months.
Time frame: 6-9 months after hospital discharge.
Incidence of combined kidney disease progression and albuminuria at 12-15 months.
Time frame: 12-15 months after hospital discharge.
Factors associated with all-cause mortality at 6-9 months.
Time frame: 6-9 months after hospital discharge.
Factors associated with all-cause mortality at 12-15 months.
Time frame: 12-15 months after hospital discharge.
Incidence of hospital readmissions at 6-9 months
Time frame: 6-9 months after hospital discharge.
Incidence of hospital readmissions at 12-15 months
Time frame: 12-15 months after hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Nitin V Kolhe, Doctor principal investigator
University Hospitals of Derby and Burton NHS Foundation Trust
1 site in 1 country: see every site and its status.
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 at 1 site in United Kingdom.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of kidney disease progression at 12 months. (time frame: 12 months after hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2025.