Acute Kidney InjuryNCT04706325
COVID-19 RELATED KIDNEY DAMAGE
An observational study of Acute Kidney Injury, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- ACUTE KIDNEY INJURY
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Over 18 aged * patients in ICU
Who may be able to join
- Over 18 aged
- patients in ICU
Who cannot join
- Patients with known Chronic Renal Failure
- who have received dialysis treatment before
- who are under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akif Şahin
Kocaeli
mehmet yılmaz, 05052174432, drmyilmaz33@gmail.com
About this study
Official title: INVESTIGATION OF RISK FACTORS RELATED TO COVID-19 RELATED KIDNEY DAMAGE: A PROSPECTIVE OBSERVATIONAL STUDY
In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. In addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. In addition, we are investigating whether it has a positive effect on patients' survival. In other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with COVID-19 with acute kidney damage.
- Conditions
- Acute Kidney Injury
- Being tested
- ACUTE KIDNEY INJURY
- 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.
ACUTE KIDNEY INJURYOther
KDIGO LEVELS
| Study group | Role | What they receive |
|---|---|---|
| COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE | COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE Receives: Other: ACUTE KIDNEY INJURY | |
| COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE | COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE Receives: Other: ACUTE KIDNEY INJURY | |
| COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE. | COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE. Receives: Other: ACUTE KIDNEY INJURY |
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO
Kidney Disease: Improving Global Outcomes
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Jan 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion15 May 2021 (estimated)
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 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aki̇f Şahi̇n, Kocaeli Derince Education and Research Hospital
- Investigators
- akif şahin, Principal investigator, kocaeli derh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706325
- Sponsor's protocol ID
- kocaeli derh
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
PubMed 32247631Aleebrahim-Dehkordi E, Reyhanian A, Saberianpour Sh, Hasanpour-Dehkordi A. Acute kidney injury in COVID-19; a review on current knowledge. J Nephropathol. 2020;9:e31. doi: 10.34172/jnp.2020.31
Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
PubMed 32222812
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF RISK FACTORS RELATED TO COVID-19 RELATED KIDNEY DAMAGE: A PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT04706325
- Acronym / sponsor ID
- kocaeli derh
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 12 Jan 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.
In this study, we investigate whether the early detection of risk factors in Covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. We predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. In addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. In addition, we are investigating whether it has a positive effect on patients' survival. In other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with COVID-19 with acute kidney damage.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE | – | Other: ACUTE KIDNEY INJURYCOVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE |
| COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE | – | Other: ACUTE KIDNEY INJURYCOVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE |
| COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE. | – | Other: ACUTE KIDNEY INJURYCOVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over 18 aged * patients in ICU
Key inclusion criteria (2 listed)
- Over 18 aged
- patients in ICU
Key exclusion criteria (3 listed)
- Patients with known Chronic Renal Failure
- who have received dialysis treatment before
- who are under 18 years of age
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 |
|---|---|---|
| ACUTE KIDNEY INJURYKDIGO LEVELS | Other | COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE, COVİD19 PCR (Polymerase Chain Reaction) AND CT will be evaluated as NEGATIVE., COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE |
Primary outcome
KDIGO
Time frame: 4 MONTHS
Kidney Disease: Improving Global Outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Results publication: PubMed 32247631Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney Int. 2020 May;97(5):829-838. doi: 10.1016/j.kint.2020.03.005. Epub 2020 Mar 20.
- Results publicationAleebrahim-Dehkordi E, Reyhanian A, Saberianpour Sh, Hasanpour-Dehkordi A. Acute kidney injury in COVID-19; a review on current knowledge. J Nephropathol. 2020;9:e31. doi: 10.34172/jnp.2020.31
- Results publication: PubMed 32222812Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Recruiting
LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
Acute Kidney Injury, Dialysis; Complications
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
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.
akif şahin principal investigator
kocaeli derh
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 Kocaeli Derince Education and Research Hospital 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 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: status not confirmed, as of the sponsor's last update on 12 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mehmet yılmaz (05052174432, drmyilmaz33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KDIGO (time frame: 4 MONTHS). 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 NCT04706325, 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 12 Jan 2021.