NCT05988658

Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 health record based AKI risk score, the investigators will enroll patients who are at high risk for the impending development of KDIGO Stage 2 AKI (top 10% of risk). Once identified and enrolled, patients will have blood and urine samples collected over the next 3 days. The investigators will recruit two cohorts of 400 patients across the two institutions. In the development cohort, the investigators will see if adding urinary or blood biomarkers of AKI can improve the ability of EHR-risk score to predict the development of Stage 2 AKI and other outcomes. The investigators will compare the area under the receiver operator characteristic curve (AUC) for the risk score alone versus the risk score plus biomarkers. The investigators will then seek to validate our findings in a separate cohort of 400 patients.

Conditions

• Acute Kidney Injury
• Biomarkers

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-01-05
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2023-08-14
• Last updated: 2025-09-12

Locations

2 sites across 1 country: United States