Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
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).
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)
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
Disqualifiers
Voluntary refusal or missing written consent of the patient / legal representative.
Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
Patients without a measured serum creatinine value during their inpatient stay.
Patients with a creatinine >4.0 mg/dl at the time of admission or available in the EHR from the last 6 months
Trial population
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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ESTOP - AKI 2.0
DeviceMedical software as a Noninvasive medical device, which at the time of the project will not implement directly into subject/clinical care.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Study cohort1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Within 7 days of enrollmentSecondary outcomes
1
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)
Time frame
within 12 hour of each observation, within 7 days of enrollment and 90 day MAKE outcome2
Recipient of renal replacement therapy(RRT)
The number of patients who receive RRT
Time frame
within 7 days of enrollment and 90 day make outcome3
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): 1. Hyperkalemia (≥ 6 mmol/L) 2. Diuretic-resistant hypervolemia (difficult to define) 3. BUN urea serum levels greater than or equal to 150mg/ dL 4. Severe metabolic acidosis (pH ≤ 7.15) 5. Oliguria (urinary output \< 200mL/12hr), or anuria.
Time frame
within 12 hour of each observation, within 7 days of enrollment and 90 day make outcome4
Change in Mortality Status during hospitalization
Patients' mortality status during current hospitalization
Time frame
within 12 hour of each observation, within 7 days of enrollment and during current hospitalizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Wisconsin, Madison
Collaborator
Source ClinicalTrials.gov