Prognosis and Risk Factors for Acute Kidney Injury | NCT06898944

Studies
Prognosis and Risk Factors for Acute Kidney Injury

NCT06898944

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Apr 2, 2025Actual

Enrollment

320,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 20, 2025

First Submission Date that Met QC Criteria

Mar 20, 2025

First Posted Date

Mar 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2025

Last Update Posted Date

Apr 2, 2025Actual

Name	Class
Seoul National University Bundang Hospital	OTHER
SMG-SNU Boramae Medical Center	OTHER
Keimyung University Dongsan Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sehoon Park, M.D. Ph.D.	Contact	+82-02-2072-4070		mailofsehoon@gmail.com
Jin Kyung Kwon, M.D.	Contact	+82-02-2072-4070		jkk1456@naver.com

Overall Officials

Name	Affiliation	Role
Dong Ki Kim, M.D. Ph.D.	Department of Internal Medicine, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided