Covid19AKI-COVID-19NCT04872764
Acute Kidney Injury in Patients With CoVID-19
An observational study of Covid19 and Acute Kidney Injury, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Acute Kidney Injury
- What is being tested?
- duration of hospitalization, mortality rate
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 20 Dec 2020
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients hospitalised for COVID-19 with and without acute kidney injury
Who may be able to join
- Patients hospitalised with COVID-19.
- Patients hospitalised with COVID-19 with Acute Kidney Injury
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acute Kidney Injury on Prognosis in Patients Hospitalised for COVID-19.
We aimed to investigate the effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19.
Read the detailed description
The effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19. Patients hospitalised for COVID-19 and acute kidney injury will be enrolled. The duration of hospitalisation, mortality rates will be compared in COVID-19 patients with and without acute kidney injury.
- Conditions
- Covid19, Acute Kidney Injury
- Being tested
- duration of hospitalization, mortality rate
- 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.
duration of hospitalization, mortality rateOther
duration of hospitalization, mortality rates of patients hospitalised for COVID-19 evaluated and compared in patients with and without acute kidney injury.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients with acute kidney injury | COVID-19 patients with acute kidney injury Receives: Other: duration of hospitalization, mortality rate | |
| COVID-19 patients without acute kidney injury | COVID-19 patients without acute kidney injury Receives: Other: duration of hospitalization, mortality rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rates of COVID-19 patients with and without Acute Kidney Injury
Measured: 6 months
duration of hospitalisation
time between admission to hospital and discharge for COVID-19 patients with and without Acute Kidney Injury
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start20 Mar 2020
- Primary completion20 Nov 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zelal Adibelli, Uşak University
- Investigators
- Zelal Adibelli, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872764
- Sponsor's protocol ID
- UsakU3
- Acronym
- AKI-COVID-19
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 4 May 2021
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acute Kidney Injury on Prognosis in Patients Hospitalised for COVID-19.
- ClinicalTrials.gov ID
- NCT04872764
- Acronym / sponsor ID
- AKI-COVID-19 / UsakU3
- Conditions
- Covid19, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 4 May 2021 (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.
We aimed to investigate the effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19.
Detailed description
The effect of Acute Kidney Injury (AKİ) on the prognosis of patients hospitalised for COVID-19. Patients hospitalised for COVID-19 and acute kidney injury will be enrolled. The duration of hospitalisation, mortality rates will be compared in COVID-19 patients with and without acute kidney injury.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients with acute kidney injury | – | Other: duration of hospitalization, mortality rateCOVID-19 patients with acute kidney injury |
| COVID-19 patients without acute kidney injury | – | Other: duration of hospitalization, mortality rateCOVID-19 patients without acute kidney injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised for COVID-19 with and without acute kidney injury
Key inclusion criteria (2 listed)
- Patients hospitalised with COVID-19.
- Patients hospitalised with COVID-19 with Acute Kidney Injury
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| duration of hospitalization, mortality rateduration of hospitalization, mortality rates of patients hospitalised for COVID-19 evaluated and compared in patients with and without acute kidney injury. | Other | COVID-19 patients with acute kidney injury, COVID-19 patients without acute kidney injury |
Primary outcome
mortality rate
Time frame: 6 months
mortality rates of COVID-19 patients with and without Acute Kidney Injury
duration of hospitalisation
Time frame: 6 months
time between admission to hospital and discharge for COVID-19 patients with and without Acute Kidney Injury
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 4 May 2021.
- 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.
Zelal Adibelli principal investigator
Uşak University
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 Covid19 and Acute Kidney Injury, run by Uşak 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 2 inclusion and 1 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 4 May 2021. 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?
mortality rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 4 May 2021.