NCT Number: NCT07217808
Acute kidney injury (AKI) affects up to 20% of hospitalized Veterans and is strongly associated with morbidity and death. AKI is a diverse condition and timely and accurate diagnosis of the type of AKI is critical to begin appropriate therapies, especially those causes that require specific treatments beyond general supportive care. Yet, there are still significant gaps in the initial evaluation of AKI among hospitalized patients. Clinical decision support systems (CDSS) have shown promise to address these barriers, but most consist of simple alerting schemes and general care recommendations provided at a single point in time. The goal of this proposal is to develop and test the feasibility and usability of a rule-based and Artificial Intelligence-assisted precision CDSS tool (PRECISE-AKI) that can provide cognitive support to improve timely initial diagnostic evaluation of AKI.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37212-2637, United States
Edward D Siew, MD MSc
PRINCIPAL_INVESTIGATOR
Michael E Matheny, MD MS MPH
PRINCIPAL_INVESTIGATOR
Michele Lenoue-Newton, PhD
CONTACT
Acute kidney injury (AKI), defined as a sudden loss of kidney function, affects up to 20% of hospitalized Veterans and is strongly associated with chronic kidney disease, poor quality of life, and death. Clinical practice guidelines recommend timely identification of the cause of AKI, but gaps remain in conducting the initial and subsequent diagnostic evaluation. Some causes of AKI also require specific treatments beyond supportive care, can be challenging to diagnose, and can require even more detailed evaluation including kidney biopsies. This clinical trial will evaluate the usability and feasibility of an Artificial Intelligence (AI)-assisted automated and comprehensive precision CDSS tool (PRECISE-AKI) to provide iterative cognitive support of general and nephrology-based providers in the diagnostic evaluation of hospitalized patients experiencing AKI within the Tennessee Valley Health Systems (TVHS). The investigators hypothesize that PRECISE-AKI will be acceptable, appropriate, and feasible to a variety of users and improve the diagnostic evaluation of hospitalized patients AKI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool
Time frame: Up to 30 days
Based on the presenting context, the investigators will compare rates of appropriate diagnostic testing between intervention and control patients among those meeting the AKI case definition
Time frame: During Index Hospitalization through 30 days
For this exploratory clinical outcome, we will compare differences in the peak KDIGO AKI Stage (creatinine-based criteria) during hospitalization after meeting the case definition of AKI between intervention and control cases.
Time frame: Last serum creatinine during index hospitalization through 30 days
The investigators will compare differences in the hospital discharge serum creatinine after meeting the case definition of AKI between intervention and control cases.
Time frame: 90 days
For this exploratory clinical outcome, the investigators will compare the rates of the major adverse kidney events experienced by eligible AKI cases in the intervention compared with the control arm. Major Adverse Kidney Events will be defined as kidney replacement therapy, death, or an increase in baseline serum creatinine of 150% of baseline using the last serum creatinine available up to 90 days.
Contact information is provided by the study sponsor or research team.
Edward D Siew, MD MSc
CONTACT
Michael E Matheny, MD MS MPH
CONTACT
VA Office of Research and Development
Fed
Acronym: PRECISE-AKI
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