COVID -19NCT07089693
Acute Kidney Injury in Critical COVID-19: Outcomes and Risks
An observational study of COVID -19 and Acute Kidney Injury, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to determine the incidence of acute kidney injury (AKI) associated with COVID-19, risk factors, and effects on mortality for intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID -19, Acute Kidney Injury, Intensive Care Unit (ICU) Admission
- How many people
- 238 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 15 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 18 and older) with PCR-confirmed COVID-19 who were admitted to the intensive care unit (ICU) at Ankara University Hospital between January 1,2021 and January 1,2022. All patients had available records and remained in the ICU for at least 48 hours.
Who may be able to join
- Age 18 years or older
- Hospitalized patients with COVID-19 confirmed by PCR test
- Required follow-up in the intensive care unit between January 1, 2021 and January 1, 2022
Who cannot join
- Patients with end-stage renal disease (ESRD)
- History of renal transplantation
- Intensive care unit stay shorter than 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Risk Factors, Incidence and Mortality Rates of Acute Kidney Injury in COVID-19 Patients Hospitalized in Intensive Care Unit
This retrospective observational study aims to determine the incidence of acute kidney injury (AKI) associated with COVID-19, risk factors, and effects on mortality for intensive care unit patients. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. Patients were divided into two groups according to the level of renal damage (with and without AKI). Those with AKI were staged per the KDIGO criteria (Stage 1-2-3). Demographic data, comorbidities, Charlson comorbidity indexes, Acute Physiology and Chronic Health Evaluation scores, laboratory results, and mortality data were examined. The data obtained were compared between the groups.
The findings may help improve clinical awareness and guide management strategies in intensive care unit patients with COVID-19 at risk of AKI
Read the detailed description
This retrospective, single-center observational study was conducted at Ankara University Hospital. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. The objective of the study was to investigate the frequency, risk factors, and impact on mortality of acute kidney injury (AKI) in adult patients hospitalized with confirmed COVID-19 infection.
Patients with a confirmed diagnosis of COVID-19 and available renal function data were included in the analysis. AKI was defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Demographic characteristics, comorbidities, laboratory values, and clinical parameters were evaluated to identify potential risk factors for AKI development. The relationship between the presence and severity of AKI and in-hospital mortality was assessed.
The study aims to provide insight into the burden of COVID-19-associated AKI and to support improved clinical decision-making for identifying and managing high-risk patients in hospital settings.
- Keywords
- COVID-19, acute kidney injury, intensive care unit, risk factors, incidence
- Medical subject headings
- COVID-19, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-AKI | Not described | |
| stage 1 AKI | Not described | |
| stage 2 AKI | Not described | |
| stage 3 AKI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care unit mortality
To evaluate whether the development of AKI is associated with mortality in COVID-19 patients monitored in the intensive care unit.
Measured: From ICU admission until in-hospital death or ICU discharge, whichever occurs first, assessed up to 90 days.
Secondary outcomes (3)
Length of intensive care unit stay
To assess whether the development of AKI in COVID-19 patients is associated with the length of stay in the intensive care unit.
Measured: From ICU admission until ICU discharge, assessed up to 12 months.
Incidence of acute kidney injury
To determine the incidence of AKI among COVID-19 patients, defined by the KDIGO criteria.
Measured: From ICU admission until AKI diagnosis or ICU discharge, whichever occurs first, assessed during hospitalization (up to 100 days).
Association between patient characteristics and AKI development
To identify clinical and laboratory predictors associated with AKI development in COVID-19 patients requiring intensive care, using retrospective data analysis.
Measured: From ICU admission until AKI diagnosis or ICU discharge, assessed up to 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jul 2022
- Primary completion30 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID -19Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar KARABAK BİLAL, Ankara University
- Investigators
- Gizem Kahraman, MD, Principal investigator, Ankara University Department of Anesthesiology and ReanimationMustafa Kemal Bayar, Prof, Study director, Ankara University Department of Anesthesiology and ReanimationPınar Karabak Bilal, MD, Principal investigator, Ankara University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089693
- Sponsor's protocol ID
- İ05-257-22
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259Ratnayake A, Sarnowski A, Sinclair F, Annear NMP, Banerjee D, Chis Ster I. The dynamics and outcomes of AKI progression during the COVID-19 pandemic. Nephrology (Carlton). 2024 Jun;29(6):325-337. doi: 10.1111/nep.14297. Epub 2024 Mar 28.
PubMed 38549280Guissouma J, Ben Ali H, Allouche H, Trabelsi I, Hammami O, Yahia Y, Hatem G. Acute Kidney Injury Complicating Critical Forms of COVID-19: risk Factors and Prognostic Impact. F1000Res. 2025 Jan 2;13:497. doi: 10.12688/f1000research.144105.3. eCollection 2024.
PubMed 39839732Aklilu AM, Kumar S, Nugent J, Yamamoto Y, Coronel-Moreno C, Kadhim B, Faulkner SC, O'Connor KD, Yasmin F, Greenberg JH, Moledina DG, Testani JM, Wilson FP. COVID-19-Associated Acute Kidney Injury and Longitudinal Kidney Outcomes. JAMA Intern Med. 2024 Apr 1;184(4):414-423. doi: 10.1001/jamainternmed.2023.8225.
PubMed 38407862
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Risk Factors, Incidence and Mortality Rates of Acute Kidney Injury in COVID-19 Patients Hospitalized in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07089693
- Acronym / sponsor ID
- İ05-257-22
- Keywords
- COVID-19, acute kidney injury, intensive care unit, risk factors, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 28 Jul 2025 (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 retrospective observational study aims to determine the incidence of acute kidney injury (AKI) associated with COVID-19, risk factors, and effects on mortality for intensive care unit patients. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. Patients were divided into two groups according to the level of renal damage (with and without AKI). Those with AKI were staged per the KDIGO criteria (Stage 1-2-3). Demographic data, comorbidities, Charlson comorbidity indexes, Acute Physiology and Chronic Health Evaluation scores, laboratory results, and mortality data were examined. The data obtained were compared between the groups.
The findings may help improve clinical awareness and guide management strategies in intensive care unit patients with COVID-19 at risk of AKI
Detailed description
This retrospective, single-center observational study was conducted at Ankara University Hospital. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. The objective of the study was to investigate the frequency, risk factors, and impact on mortality of acute kidney injury (AKI) in adult patients hospitalized with confirmed COVID-19 infection.
Patients with a confirmed diagnosis of COVID-19 and available renal function data were included in the analysis. AKI was defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Demographic characteristics, comorbidities, laboratory values, and clinical parameters were evaluated to identify potential risk factors for AKI development. The relationship between the presence and severity of AKI and in-hospital mortality was assessed.
The study aims to provide insight into the burden of COVID-19-associated AKI and to support improved clinical decision-making for identifying and managing high-risk patients in hospital settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-AKI | – | – |
| stage 1 AKI | – | – |
| stage 2 AKI | – | – |
| stage 3 AKI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 18 and older) with PCR-confirmed COVID-19 who were admitted to the intensive care unit (ICU) at Ankara University Hospital between January 1,2021 and January 1,2022. All patients had available records and remained in the ICU for at least 48 hours.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Hospitalized patients with COVID-19 confirmed by PCR test
- Required follow-up in the intensive care unit between January 1, 2021 and January 1, 2022
Key exclusion criteria (3 listed)
- Patients with end-stage renal disease (ESRD)
- History of renal transplantation
- Intensive care unit stay shorter than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intensive care unit mortality
Time frame: From ICU admission until in-hospital death or ICU discharge, whichever occurs first, assessed up to 90 days.
To evaluate whether the development of AKI is associated with mortality in COVID-19 patients monitored in the intensive care unit.
3 secondary outcomes
Length of intensive care unit stay
Time frame: From ICU admission until ICU discharge, assessed up to 12 months.
Incidence of acute kidney injury
Time frame: From ICU admission until AKI diagnosis or ICU discharge, whichever occurs first, assessed during hospitalization (up to 100 days).
Association between patient characteristics and AKI development
Time frame: From ICU admission until AKI diagnosis or ICU discharge, assessed up to 100 days.
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 28 Jul 2025.
- Results publication: PubMed 32191259Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
- Results publication: PubMed 38549280Ratnayake A, Sarnowski A, Sinclair F, Annear NMP, Banerjee D, Chis Ster I. The dynamics and outcomes of AKI progression during the COVID-19 pandemic. Nephrology (Carlton). 2024 Jun;29(6):325-337. doi: 10.1111/nep.14297. Epub 2024 Mar 28.
- Results publication: PubMed 39839732Guissouma J, Ben Ali H, Allouche H, Trabelsi I, Hammami O, Yahia Y, Hatem G. Acute Kidney Injury Complicating Critical Forms of COVID-19: risk Factors and Prognostic Impact. F1000Res. 2025 Jan 2;13:497. doi: 10.12688/f1000research.144105.3. eCollection 2024.
- Results publication: PubMed 38407862Aklilu AM, Kumar S, Nugent J, Yamamoto Y, Coronel-Moreno C, Kadhim B, Faulkner SC, O'Connor KD, Yasmin F, Greenberg JH, Moledina DG, Testani JM, Wilson FP. COVID-19-Associated Acute Kidney Injury and Longitudinal Kidney Outcomes. JAMA Intern Med. 2024 Apr 1;184(4):414-423. doi: 10.1001/jamainternmed.2023.8225.
- Individual participant dataSharing planned: No
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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.
Gizem Kahraman, MD principal investigator
Ankara University Department of Anesthesiology and Reanimation
Mustafa Kemal Bayar, Prof study director
Ankara University Department of Anesthesiology and Reanimation
Pınar Karabak Bilal, MD principal investigator
Ankara University Department of Anesthesiology and Reanimation
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 COVID -19 and Acute Kidney Injury, run by Ankara University at 1 site in Turkey (Türkiye).
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 3 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 28 Jul 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 Turkey (Türkiye). 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?
Intensive care unit mortality (time frame: From ICU admission until in-hospital death or ICU discharge, whichever occurs first, assessed up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089693, which also lists 4 linked publications.
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 28 Jul 2025.