Recruiting

Biomarkers & Risk Scores

Sponsor:

University of Chicago

Code:

NCT05988658

Conditions

Acute Kidney Injury

Biomarkers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ESTOP - AKI 2.0

Study Details

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 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.

Conditions

Acute Kidney Injury

Biomarkers

Study ID

NCT05988658

Start date

Jan 5, 2024

Status verified date

Sep, 2025

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years
2. 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).
3. 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)
4. 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 Criteria:

1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine >4.0 mg/dl at the time of admission or available in the EHR from the last 6 months
5. Patients with prior episode of KDIGO defined AKI during this same hospitalization- regardless of E-STOP AKI 2.0 score
6. Patients with prior renal consultation during their admission.
7. Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago during this same hospital stay.
8. Incarcerated patients
9. Pregnant patients

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

ESTOP - AKI 2.0

Medical software as a Noninvasive medical device, which at the time of the project will not implement directly into subject/clinical care.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Jay Koyner, MD

University of Wisconsin Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Matthew Churpek, MD,MPH,PhD

More Information

Sponsor

University of Chicago

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • Acute Kidney Injury
  • Biomarkers
  • Renal Replacement Therapy
  • Artificial Intelligence
  • Risk Assessment
  • Clinical Nephrology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-09-12.