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 — DEVICEMedical 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 cohortPatients 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
- Jay Koyner, MD773-702-4842
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Jay Koyner, MD (PRINCIPAL_INVESTIGATOR) |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | Matthew Churpek, MD,MPH,PhD (PRINCIPAL_INVESTIGATOR) |
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