COVID-19 RELATED KIDNEY DAMAGE

• ClinicalTrials.gov Identifier: NCT04706325
• Recruitment Status: Unknown
• First Posted: January 12, 2021
• Last Update Posted: January 12, 2021
• Sponsor: Kocaeli Derince Education and Research Hospital
• Information provided by (Responsible Party): Aki̇f Şahi̇n, Kocaeli Derince Education and Research Hospital

Tracking Information

• First Submitted Date: January 11, 2021
• First Posted Date: January 12, 2021
• Last Update Posted Date: January 12, 2021
• Estimated Study Start Date: January 1, 2021
• Estimated Primary Completion Date: May 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 11, 2021)

KDIGO [ Time Frame: 4 MONTHS ]

Kidney Disease: Improving Global Outcomes

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: COVID-19 RELATED KIDNEY DAMAGE
• Official Title: INVESTIGATION OF RISK FACTORS RELATED TO COVID-19 RELATED KIDNEY DAMAGE: A PROSPECTIVE OBSERVATIONAL STUDY
• Brief 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. 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample

Study Population

Over 18 aged

• patients in ICU

• Condition: Acute Kidney Injury

Intervention

Other: ACUTE KIDNEY INJURY

KDIGO LEVELS

Study Groups/Cohorts

• COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE
  COVİD19 PCR (Polymerase Chain Reaction) AND CT POSITIVE
  Intervention: Other: ACUTE KIDNEY INJURY
• COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE
  COVİD19 PCR (Polymerase Chain Reaction)NEGATİVE AND CT POSITIVE
  Intervention: 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.
  Intervention: Other: ACUTE KIDNEY INJURY

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.
• Aleebrahim-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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 11, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 15, 2021
• Estimated Primary Completion Date: May 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Over 18 aged
• patients in ICU

Exclusion Criteria:

• Patients with known Chronic Renal Failure
• who have received dialysis treatment before
• who are under 18 years of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04706325
• Other Study ID Numbers: kocaeli derh
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Aki̇f Şahi̇n, Kocaeli Derince Education and Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Kocaeli Derince Education and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: akif şahin; kocaeli derh

• PRS Account: Kocaeli Derince Education and Research Hospital
• Verification Date: January 2021