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

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05988658

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Wisconsin, Madison (Other)

800

Enrollment

Locations

Anticipated Duration (Months)

400

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 be enrolled at the University of Chicago Medical Center and the University of Wisconsin Hospital, where the risk score will be 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Biomarkers	Device: ESTOP - AKI 2.0

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, we 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. We will recruit 2 cohorts of 400 patients across the 2 institutions. In the development cohort we will see if adding urinary or serum biomarkers of AKI can improve the ability of EHR-risk score to predict the development of Stage 2 AKI and other outcomes. We will compare the area under the receiver operator characteristic curve (AUC) for the risk score alone versus the risk score plus biomarkers. We will then seek to validate our findings in a separate cohort of 400 patients.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Developing KDIGO stage 2 AKI [With in 7 days of enrollment]
Number of patients developing KDIGO Stage 2 AKI. KDIGO Stage 2 AKI is 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 can not be diagnosed

Secondary Outcome Measures

Development of KDIGO stage 3 AKI [with in 12 hour of each observation, with in 7 days of enrollment and 90 day MAKE outcome]
Number of patients developing KDIGO Stage 3 AKI KDIGO Stage 3 AKI can be 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)
Recipient of renal replacement therapy(RRT) [with in 12 hour of each observation, with in 7 days of enrollment and 90 day make outcome]
The number of patients who receive RRT due to following indications (in the setting of Stage 2/3 AKI) : Hyperkalemia (≥ 6 mmol/L) Diuretic-resistant hypervolemia (difficult to define) BUN urea serum levels greater than or equal to 150mg/ dL Severe metabolic acidosis (pH ≤ 7.15) Oliguria (urinary output < 200mL/12hr), or anuria.
Change in Mortality Status during hospitalization [with in 12 hour of each observation, with in 7 days of enrollment and during current hospitalization]
Patients' mortality status during current hospitalization
Major Adverse Kidney Events (MAKE) Outcomes [3 months (90 days)]
Number of Participants developing Major Adverse Kidney Events (MAKE) : Recurrent Hospitalization Kidney Function Status: Recurrent AKI New chronic kidney disease (CKD) Need or continued need for RRT Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients with prior episode of KDIGO defined AKI during this same hospitalization- regardless of E-STOP AKI 2.0 score
Patients with prior renal consultation during their admission.
Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago during this same hospital stay.
Incarcerated patients
Pregnant patients