Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05988658
Status
Recruiting

Conditions

  • Acute Kidney Injury
  • Biomarkers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ESTOP - AKI 2.0 — DEVICE
    Medical software as a Noninvasive medical device, which at the time of the project will not implement directly into subject/clinical care.

Study Details

The study's objective is to evaluate the additive value of renal biomarkers (from blood and urine) for identifying individuals at high risk for severe acute kidney injury (AKI) above that of a novel natural language processing (NLP)-based AKI risk algorithm. The risk algorithm is based on electronic health records (EHR) data (labs, vitals, clinical notes, and test reports). Patients will enroll at the University of Chicago Medical Center and the University of Wisconsin Hospital, where the risk score will run in real time. The risk score will identify those patients with the highest risk for the future development of Stage 2 AKI and collect blood and urine for biomarker measurement over the subsequent 3 days.

Key Dates

Start date
Jan 5, 2024
Status verified
Sep 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Study cohort
    Patients will be identified as high risk based on their AKI risk score (ESTOP- AKI 2.0) being in the top 10% of all hospitalized patients

Primary Outcome Measure

Developing KDIGO stage 2 AKI [ Time Frame: Within 7 days of enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Aiman Fatima, MBBS
773-702-6201
Ola Anjorin, MBBS,DA,MPH
773-704-3168
Jay Koyner, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin HospitalMadisonWisconsin53792
Madeline Ogus, MS
608-265-2878
Michael Weber
608-263-3369
Matthew Churpek, MD,MPH,PhD (PRINCIPAL_INVESTIGATOR)

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