NCT06597838

Brief Summary

Early prediction of acute kidney injury (AKI) may provide a crucial opportunity for AKI prevention. To date, no prediction model targeting AKI among general hospitalized patients in developing countries has been published. We developed a simple, real-time, interpretable AKI prediction model for general hospitalized patients from a large tertiary hospital in China, and validated it across five independent, geographically distinct, different tiered hospitals.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
161,876

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

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 Start

First participant enrolled

February 28, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 9, 2024

Last Update Submit

September 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Predictive performance of the prediction model for Acute Kidney Injury

    Evaluated using AUC

    through study completion, varied from one to three years in different validation cohorts.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients admitted to five hospitals during the study period.

You may qualify if:

  • Adult patients (18 years and older) admitted to five hospitals during the study period

You may not qualify if:

  • Have less than 2 documented serum creatinine (Scr) measurements during hospitalization
  • Being diagnosed with end-stage renal disease (ESRD)
  • Maintained on dialysis or had an initial Scr greater than or equal to 4.0 mg/dL at admission
  • Developed AKI prior to admission or within 24 hours after admission
  • Length of stay shorter than 24 hours
  • Underwent kidney transplantation or nephrectomy during hospitalization
  • With all Scr measurements lower than or equal to 0.6 mg/dL from 90 days prior to admission until discharge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Study Officials

  • Li Yang

    Peking University First Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

February 28, 2023

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations