Clinical trial NCT06898944: Prognosis and Risk Factors for Acute Kidney Injury
Official title: Analysis for Prognosis and Risk Factors for Acute Kidney Injury: Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: Keimyung University Dongsan Medical Center
First posted: 2025-03-27
Enrollment: 320000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥20 years old) who visited Parcitipating Medical Center (Seoul National University Hospital, Bundang Seoul National University Hospital, SMG-SNU Boramae Medical Center, Keimyung University Dongsan Medical Center) between 2006 and 2021

Brief summary: The aim of our study is to analyze the accurate diagnosis and prognosis of acute kidney injury (AKI) based on its severity and to define long-term clinical and socioeconomic outcomes.

Investigators defined the AKI group among adults aged 20 years or older who visited enrolled center and underwent at least two blood tests, including serum creatinine, within an interval of 7 days or less and a control group was matched 1:1 to the AKI group based on age, sex, year of visit, and baseline kidney function, forming the study population. Investigators then collected and analyzed various clinical, laboratory, and hospitalization records including demographic data, anthropometric data, laboratory data, and medical history.


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years old who visited Parcitipating Medical Center (Seoul National University Hospital, Bundang Seoul National University Hospital, SMG-SNU Boramae Medical Center, Keimyung University Dongsan Medical Center) between 2006 and 2021
* The AKI group is defined as individuals meeting the AKI diagnostic criteria of the KDIGO Guideline (an increase in serum creatinine of ≥0.3 mg/dL or ≥1.5 times the baseline level) is enrolled.
* The Control Group is defined as individuals from the study population who do not meet the AKI criteria and are matched 1:1 based on age, sex, year of visit, and baseline renal function.

Exclusion Criteria:

* Individuals under 20 years old
* Individuals who did not undergo serum creatinine tests meeting the criteria
* Individuals with pre-existing end-stage kidney disease (ESKD) who have undergone dialysis or kidney transplantation

Primary outcomes:
measure: Change from Baseline in Serum Creatinine
timeFrame: From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date
Secondary outcomes:
measure: Change from Baseline in Urine Protein/Creatinine Ratio
timeFrame: From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date
measure: Incidence of Receiving Renal Replacement Therapy
timeFrame: From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date
measure: Change from Baseline in Serum Hemogloblin Level
timeFrame: From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date
measure: Change from Baseline in Serum Albumin Level
timeFrame: From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine, Seoul National University Hospital
name: Dong Ki Kim, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: