Status:
RECRUITING
Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Wisconsin, Madison
Conditions:
Acute Kidney Injury
Biomarkers
Eligibility:
All Genders
18+ years
Brief Summary
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 n...
Detailed Description
The investigators hypothesize that combining the biomarkers with electronic health risk score will impact improvement in AKI risk stratification. Using a real time, externally validated electronic hea...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- E-STOP AKI 2.0 score in the top 10% of risk (historically from all hospitalized patients) within the last 12 hours. (First time across this 10% risk threshold during this hospital stay).
- Admitted to an inpatient ward, intermediate, or ICU care at the University of Chicago Medical Center (UCMC) or University of Wisconsin Health (UWHealth). (No Emergency Department patients)
- Patient or their legally authorized representative must be able to read, speak, and understand English, for the purposes of consenting. Otherwise, inclusion in this protocol will be done without regard to race, ethnic origin or gender
Exclusion
- Voluntary refusal or missing written consent of the patient / legal representative.
- Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
- Patients without a measured serum creatinine value during their inpatient stay.
- Patients with a creatinine \>4.0 mg/dl at the time of admission or available in the EHR from the last 6 months
- Patients with prior episode of KDIGO defined AKI during this same hospitalization- regardless of E-STOP AKI 2.0 score
- Patients with prior renal consultation during their admission.
- Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago during this same hospital stay.
- Incarcerated patients
- Pregnant patients
Key Trial Info
Start Date :
January 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05988658
Start Date
January 5 2024
End Date
March 1 2028
Last Update
September 12 2025
Active Locations (2)
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1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
2
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792