Clinical trial NCT05988658: Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
Official title: Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Biomarkers
Keywords: Acute Kidney Injury
Biomarkers
Renal Replacement Therapy
Artificial Intelligence
Risk Assessment
Clinical Nephrology
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Wisconsin, Madison
First posted: 2023-08-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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)

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. 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).
3. 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)
4. 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:

1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine \>4.0 mg/dl at the time of admission or available in the EHR from the last 6 months
5. Patients with prior episode of KDIGO defined AKI during this same hospitalization- regardless of E-STOP AKI 2.0 score
6. Patients with prior renal consultation during their admission.
7. Patient with an E-STOP AKI 2.0 above the top 10% risk threshold more than 12 hours ago during this same hospital stay.
8. Incarcerated patients
9. Pregnant patients

Primary outcomes:
measure: Developing KDIGO stage 2 AKI
timeFrame: Within 7 days of enrollment
Secondary outcomes:
measure: Development of KDIGO stage 3 AKI
timeFrame: within 12 hour of each observation, within 7 days of enrollment and 90 day MAKE outcome
measure: Recipient of renal replacement therapy(RRT)
timeFrame: within 7 days of enrollment and 90 day make outcome
measure: Clinical indication for the receipt of renal replacement therapy(RRT)
timeFrame: within 12 hour of each observation, within 7 days of enrollment and 90 day make outcome
measure: Change in Mortality Status during hospitalization
timeFrame: within 12 hour of each observation, within 7 days of enrollment and during current hospitalization
measure: Major Adverse Kidney Events (MAKE) Outcomes
timeFrame: 3 months (90 days)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: University of Chicago
name: Jay Koyner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Matthew Churpek, MD,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
References: