Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury (PRECISE-AKI)

October 15, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
        • Contact:
        • Principal Investigator:
          • Edward D Siew, MD MSc
        • Principal Investigator:
          • Michael E Matheny, MD MS MPH

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control (Usual Care)
The Control arm will consist of usual care with no additional clinical decision support tool guidance
Experimental: PRECISION AKI Clinical Decision Support
The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool
Other: PRECISE-AKI Clinical Decision Support Tool
The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of Appropriate Diagnostic Testing
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
Up to 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Clinical Outcome: Peak Kidney Disease Improving Global Outcomes (KDIGO) AKI Stage during hospitalization.
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.
During Index Hospitalization through 30 days
Exploratory Clinical Outcome: Discharge serum creatinine
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.
Last serum creatinine during index hospitalization through 30 days
Exploratory Clinical Outcome: Major Adverse Kidney Events (MAKE) 90
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanderbilt University Medical Center
VA Tennessee Valley Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward D Siew, MD MSc, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • Principal Investigator: Michael E Matheny, MD MS MPH, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

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 Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2028

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR3-017-24W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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