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This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Nephrology Consult (ENC) | Experimental | The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations. |
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| Standard of Care (SOC) | Active Comparator | Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Nephrology Consult (ENC) | Other | The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval | The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups. | 7-day interval |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences by treatment group in the proportion by percent and time in days to specified medical events. | The differences will be measured by treatment group in the proportion and time to event of patients who a) develop > Stage 2 AKI, b) require renal replacement therapy (RRT), c) undergo intensive care unit (ICU) transfer, and/or d) require non-research nephrology consult. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Koyner, MD | University of Chicago Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | 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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care (SOC) | Other | Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. |
|
| Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital. | The differences will be measured by treatment group in the proportion by percent and time in days of LOS in the hospital. | 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |