Using biomarkers and electronic scores to predict kidney injury in hospitalized patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining renal biomarkers from blood and urine with a novel electronic health record-based risk algorithm to identify hospitalized patients at high risk for severe acute kidney injury (AKI). Patients will be enrolled at the University of Chicago Medical Center and the University of Wisconsin Hospital, where their risk scores will be calculated in real time. The study will involve collecting blood and urine samples over three days from patients identified as being in the top 10% risk for developing Stage 2 AKI. The goal is to determine if adding these biomarkers improves the predictive accuracy of the existing risk score.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• University of Wisconsin Hospital
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Jay Koyner, MD — University of Chicago
• Study coordinator: Jay Koyner, MD
• Email: jkoyner@uchicago.edu
• Phone: 773-702-4842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.