RECRUITING

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

Conditions

Acute Kidney Injury Biomarkers Renal Replacement Therapy Artificial Intelligence Risk Assessment Clinical Nephrology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-05

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05988658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Jay Koyner, MD

CONTACT

773-702-4842

jkoyner@uchicago.edu

Principal Investigator

Jay Koyner, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Matthew Churpek, MD,MPH,PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

University of Wisconsin Hospital

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: University of Chicago

Jay Koyner, MD, PRINCIPAL_INVESTIGATOR, University of Chicago
Matthew Churpek, MD,MPH,PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

Acute Kidney Injury
Biomarkers
Renal Replacement Therapy
Artificial Intelligence
Risk Assessment
Clinical Nephrology

Additional Relevant MeSH Terms

Acute Kidney Injury
Biomarkers