Using biomarkers and electronic scores to predict kidney injury in hospitalized patients
Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
This study is testing if combining blood and urine tests with a new computer risk score can better predict which hospitalized patients are at high risk for serious kidney injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05988658 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 18 and older who are in the top 10% risk for AKI based on the E-STOP AKI 2.0 score.
Not a fit: Patients with a known history of end-stage renal disease on dialysis or those with a creatinine level greater than 4.0 mg/dl will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification and intervention for patients at high risk of acute kidney injury, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using electronic health records and biomarkers for risk assessment in AKI, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.