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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK126933 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Wisconsin, Madison | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESTOP - AKI 2.0 | Device | Medical software as a Noninvasive medical device, which at the time of the project will not implement directly into subject/clinical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Developing KDIGO stage 2 AKI | Number of patients developing KDIGO Stage 2 AKI. KDIGO Stage 2 AKI defined as: A double of baseline serum creatinine from baseline OR 12 hours of urine output of less than 0.5ml/kg/hr in those with bladder catheters. If no catheter in place than urine output based AKI cannot be diagnosed | Within 7 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Development of KDIGO stage 3 AKI | Number of patients developing KDIGO Stage 3 AKI KDIGO Stage 3 AKI defined as: Increase in Serum creatinine by 3.0 times baseline OR Increase serum creatinine to > 4.0 mg/dL OR Need for Renal Replacement Therapy (RRT) | within 12 hour of each observation, within 7 days of enrollment and 90 day MAKE outcome |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted in inpatient ward, intermediate or ICU care at UCMC or UWHealth with 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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jay Koyner, MD | Contact | 773-702-4842 | jkoyner@uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jay Koyner, MD | University of Chicago | Principal Investigator |
| Matthew Churpek, MD,MPH,PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40232856 | Derived | Koyner JL, Martin J, Carey KA, Caskey J, Edelson DP, Mayampurath A, Dligach D, Afshar M, Churpek MM. Multicenter Development and Validation of a Multimodal Deep Learning Model to Predict Moderate to Severe AKI. Clin J Am Soc Nephrol. 2025 Apr 15;20(6):766-778. doi: 10.2215/CJN.0000000695. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Recipient of renal replacement therapy(RRT) | The number of patients who receive RRT | within 7 days of enrollment and 90 day make outcome |
| Clinical indication for the receipt of renal replacement therapy(RRT) | The number of patients who have a clinical indication to receive RRT (even if they do not receive it) due to following indications (in the setting of Stage 2/3 AKI):
| within 12 hour of each observation, within 7 days of enrollment and 90 day make outcome |
| Change in Mortality Status during hospitalization | Patients' mortality status during current hospitalization | within 12 hour of each observation, within 7 days of enrollment and during current hospitalization |
| Major Adverse Kidney Events (MAKE) Outcomes | Number of Participants developing Major Adverse Kidney Events (MAKE):
| 3 months (90 days) |
| University of Wisconsin Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |