NCT06898944

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2022Dec 2026

Study Start

First participant enrolled

August 22, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4.4 years

First QC Date

March 20, 2025

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Serum Creatinine

    From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date

Secondary Outcomes (4)

  • Change from Baseline in Urine Protein/Creatinine Ratio

    From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date

  • Incidence of Receiving Renal Replacement Therapy

    From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date

  • Change from Baseline in Serum Hemogloblin Level

    From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date

  • Change from Baseline in Serum Albumin Level

    From Index Date(The Date Which Acute Kidney Injury Occured) Through 5 Years After The Index Date

Study Arms (2)

AKI group

* Aged 20 years or older who visited hospital * Underwent at least two blood tests, including serum creatinine, within an interval of 7 days or less * AKI was defined based on the KDIGO criteria (an increase in serum creatinine by ≥0.3 mg/dL or ≥1.5 times the baseline).

Control group

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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dong Ki Kim, M.D. Ph.D.

    Department of Internal Medicine, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sehoon Park, M.D. Ph.D.

CONTACT

Jin Kyung Kwon, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 27, 2025

Study Start

August 22, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Locations