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Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury

Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07217808
Acronym
PRECISE-AKI
Enrollment
60
Registered
2025-10-16
Start date
2028-01-01
Completion date
2029-06-30
Last updated
2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury (AKI)

Keywords

Acute Kidney Injury, Decision Support Systems, Clinical, Artificial Intelligence

Brief summary

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.

Detailed description

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.

Interventions

OTHERPRECISE-AKI Clinical Decision Support Tool

The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool

Sponsors

VA Tennessee Valley Health Care System
CollaboratorFED
Vanderbilt University Medical Center
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

It is not possible to blind clinicians. Study data will be extracted by staff blinded to assignment.

Intervention model description

Pre-/Post- design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eligible providers will be those that have at least 4 weeks of inpatient ward team or consultation team activity during a 12-month period. * Case inclusion criteria will consist of hospitalizations that meet criteria for Kidney Disease Improving Global Outcomes Stage 2 injury or persistent Stage 1 injury seen by eligible providers.

Exclusion criteria

* Ineligible providers will be those that have \< 4 weeks of inpatient ward team of consultative team activity during a 12 month period. * Hospitalizations with non-persistent (\<48 hours) stage 1 injury or less.

Design outcomes

Primary

MeasureTime frameDescription
Rates of Appropriate Diagnostic TestingUp to 30 daysBased 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

Other

MeasureTime frameDescription
Exploratory Clinical Outcome: Peak Kidney Disease Improving Global Outcomes (KDIGO) AKI Stage during hospitalization.During Index Hospitalization through 30 daysFor 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.
Exploratory Clinical Outcome: Discharge serum creatinineLast serum creatinine during index hospitalization through 30 daysThe investigators will compare differences in the hospital discharge serum creatinine after meeting the case definition of AKI between intervention and control cases.
Exploratory Clinical Outcome: Major Adverse Kidney Events (MAKE) 9090 daysFor 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.

Countries

United States

Contacts

Primary ContactEdward D Siew, MD MSc
Edward.siew@va.gov(615) 343-1279
Backup ContactMichael E Matheny, MD MS MPH
Michael.Matheny@va.gov(615) 936-0090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026