COVID19NCT04799600
The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
An observational study of COVID19 and Acute Renal Failure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID19, Acute Renal Failure
- What is being tested?
- BRESCİA-COVİD Respiratory Severity Scale
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Jul 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.
Who may be able to join
- Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study.
Who cannot join
- there is no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors.
- Conditions
- COVID19, Acute Renal Failure
- Being tested
- BRESCİA-COVİD Respiratory Severity Scale
- Keywords
- COVID19, Acute Renal Failure
- 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.
BRESCİA-COVİD Respiratory Severity ScaleOther
KDIGO acute renal failure score BRESCİA-COVID Respiratory Severity Score
| Study group | Role | What they receive |
|---|---|---|
| Acute Renal Failure in ICU | COVID-19 Patients with Acute Renal Failure in ICU Receives: Other: BRESCİA-COVİD Respiratory Severity Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO criteria
KDIGO Criteria stage 1: Increase in SCr by ≥ 0.3 mg/dL within 48 hours or increase in SCr 1.5 to 1.9 times baseline which is known or presumed to have occurred within the prior 7 days Stage 2: 2.0 to 2.9 multiplied by baseline SCr;
Stage 3: 3.0 or more multiplied by baseline; increase in SCr ≥ 4.0 mg/dL; or beginning of renal replacement therapy regardless of a previous KDIGO stage.
Measured: 6 months
BRESCIA-COVID RESPIRATORY SEVERITY SCALE (BCRSS) scores
The BCRSS score (between level 0-8) is calculated from "www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm" according to the severity of COVID disease , respiratory rate, PaO2 level, chest x-ray, and clinical status.
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 posted16 Mar 2021
- Study start1 Sep 2020
- Primary completion15 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- betül aytaç, MD, Principal investigator, ankara ch bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799600
- Sponsor's protocol ID
- E1-20-1443
- Status last verified
- Jul 2021
- First submitted
- 10 Mar 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
PubMed 23394211Wang L, Li X, Chen H, Yan S, Li D, Li Y, Gong Z. Coronavirus Disease 19 Infection Does Not Result in Acute Kidney Injury: An Analysis of 116 Hospitalized Patients from Wuhan, China. Am J Nephrol. 2020;51(5):343-348. doi: 10.1159/000507471. Epub 2020 Mar 31.
PubMed 32229732Rodriguez-Nava G, Yanez-Bello MA, Trelles-Garcia DP, Chung CW, Friedman HJ, Hines DW. Performance of the quick COVID-19 severity index and the Brescia-COVID respiratory severity scale in hospitalized patients with COVID-19 in a community hospital setting. Int J Infect Dis. 2021 Jan;102:571-576. doi: 10.1016/j.ijid.2020.11.003. Epub 2020 Nov 9.
PubMed 33181332
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
- ClinicalTrials.gov ID
- NCT04799600
- Acronym / sponsor ID
- E1-20-1443
- Conditions
- COVID19, Acute Renal Failure
- Keywords
- COVID19, Acute Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 16 Mar 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.
Aim of the study is to determinate the frequency of acute renal failure in COVID-19 patients, its relationship with the severity of COVID-19 disease in ICU, and the ability to take precautions against these factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Renal Failure in ICU | – | Other: BRESCİA-COVİD Respiratory Severity ScaleCOVID-19 Patients with Acute Renal Failure in ICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in the intensive care unit diagnosed with COVID-19 will participate in the study.
Key inclusion criteria (1 listed)
- Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study.
Key exclusion criteria (1 listed)
- there is no exclusion criteria
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 |
|---|---|---|
| BRESCİA-COVİD Respiratory Severity ScaleKDIGO acute renal failure score BRESCİA-COVID Respiratory Severity Score | Other | Acute Renal Failure in ICU |
Primary outcome
KDIGO criteria
Time frame: 6 months
KDIGO Criteria stage 1: Increase in SCr by ≥ 0.3 mg/dL within 48 hours or increase in SCr 1.5 to 1.9 times baseline which is known or presumed to have occurred within the prior 7 days Stage 2: 2.0 to 2.9 multiplied by baseline SCr; Stage 3: 3.0 or more multiplied by baseline; increase in SCr ≥ 4.0 mg/dL; or beginning of renal replacement therapy regardless of a previous KDIGO stage.
BRESCIA-COVID RESPIRATORY SEVERITY SCALE (BCRSS) scores
Time frame: 6 months
The BCRSS score (between level 0-8) is calculated from "www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm" according to the severity of COVID disease , respiratory rate, PaO2 level, chest x-ray, and clinical status.
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 27 Jul 2021.
- Results publication: PubMed 23394211Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
- Results publication: PubMed 32229732Wang L, Li X, Chen H, Yan S, Li D, Li Y, Gong Z. Coronavirus Disease 19 Infection Does Not Result in Acute Kidney Injury: An Analysis of 116 Hospitalized Patients from Wuhan, China. Am J Nephrol. 2020;51(5):343-348. doi: 10.1159/000507471. Epub 2020 Mar 31.
- Results publication: PubMed 33181332Rodriguez-Nava G, Yanez-Bello MA, Trelles-Garcia DP, Chung CW, Friedman HJ, Hines DW. Performance of the quick COVID-19 severity index and the Brescia-COVID respiratory severity scale in hospitalized patients with COVID-19 in a community hospital setting. Int J Infect Dis. 2021 Jan;102:571-576. doi: 10.1016/j.ijid.2020.11.003. Epub 2020 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
betül aytaç, MD principal investigator
ankara ch bilkent
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 Renal Failure, run by Ankara City Hospital Bilkent 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 1 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 27 Jul 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?
KDIGO criteria (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?
On the ClinicalTrials.gov record for NCT04799600, which also lists 3 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 27 Jul 2021.