Acute Kidney Injury (AKI)PRECISE-AKINCT07217808
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
A study testing PRECISE-AKI Clinical Decision Support Tool in people with Acute Kidney Injury (AKI), run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (AKI)
- What is being tested?
- PRECISE-AKI Clinical Decision Support Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2028to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Michele Lenoue-Newton, PhD, (615) 936-6728, michele.lenoue-newton@va.gov
Edward D Siew, MD MSc
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury (AKI)
- Being tested
- PRECISE-AKI Clinical Decision Support Tool
- Keywords
- Acute Kidney Injury, Decision Support Systems, Clinical, Artificial Intelligence
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECISE-AKI Clinical Decision Support ToolOther
The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool
| Study group | Role | What they receive |
|---|---|---|
| Control (Usual Care) | No intervention | The Control arm will consist of usual care with no additional clinical decision support tool guidance |
| PRECISION AKI Clinical Decision Support | Experimental | The Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool Receives: Other: PRECISE-AKI Clinical Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Appropriate Diagnostic Testing
Based on the presenting context, the investigators will compare rates of appropriate diagnostic testing between intervention and control patients among those meeting the acute kidney injury (AKI) case definition
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (AKI)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Pre-/Post- design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Tennessee Valley Health Care System, Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Edward D Siew, MD MSc, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TNMichael E Matheny, MD MS MPH, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217808
- Sponsor's protocol ID
- HSR3-017-24W
- Other IDs
- 1I01RD000654-01A1
- Acronym
- PRECISE-AKI
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07217808
- Acronym / sponsor ID
- PRECISE-AKI / HSR3-017-24W
- Conditions
- Acute Kidney Injury (AKI)
- Keywords
- Acute Kidney Injury, Decision Support Systems, Clinical, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Tennessee Valley Health Care System, Vanderbilt University Medical Center
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pre-/Post- design
| Arm | Type | Receives |
|---|---|---|
| Control (Usual Care) | No intervention | –The Control arm will consist of usual care with no additional clinical decision support tool guidance |
| PRECISION AKI Clinical Decision Support | Experimental | Other: PRECISE-AKI Clinical Decision Support ToolThe Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRECISE-AKI Clinical Decision Support ToolThe Intervention arm will consist of Clinical Decision Diagnostic Support (CDS) provided by the PRECISE-AKI tool | Other | PRECISION AKI Clinical Decision Support |
Primary outcome
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 acute kidney injury (AKI) case definition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury (AKI)
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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Neuromuscular Electrical Stimulation to Improve the Muscle Health of Individuals With Acute Kidney Injury
Acute Kidney Injury, Acute Kidney Injury KDIGO 2
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Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes
Type 2 Diabetes Mellitus, Acute Kidney Injury
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward D Siew, MD MSc principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Michael E Matheny, MD MS MPH principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECISE-AKI Clinical Decision Support Tool in people with Acute Kidney Injury (AKI), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward D Siew, MD MSc ((615) 343-1279, Edward.siew@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Appropriate Diagnostic Testing (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.