PRECISE-AKI Tool for Kidney Failure

(PRECISE-AKI Trial)

Overseen By Michael E Matheny, MD MS MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Non-persistent stage 1 injury

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision support tool called the PRECISE-AKI Clinical Decision Support Tool, designed to help doctors diagnose acute kidney injury (AKI) more accurately and quickly. AKI is a serious condition affecting many hospitalized Veterans and can lead to complications if not treated properly. The tool uses advanced technology to guide doctors in identifying the type of AKI, aiding in the selection of appropriate treatment. Suitable participants have been hospitalized and experienced kidney issues lasting more than 48 hours. The trial will compare usual care with the new tool to determine its impact on care quality. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future AKI diagnosis and treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PRECISE-AKI Clinical Decision Support Tool is safe for use in diagnosing acute kidney injury?

Research has shown that tools like PRECISE-AKI, which assist doctors in decision-making, are generally safe and well-received. These tools enhance the diagnosis and treatment of sudden kidney problems by providing additional information and alerts, without directly affecting patients or causing harm.

Studies have found that similar tools in hospitals help doctors make better decisions without harming patients. For instance, they can predict kidney issues before they worsen. However, one study found that merely alerting doctors did not always improve kidney function. This indicates that while the tools are safe, their effectiveness can depend on their use in hospitals.

In summary, decision-support tools like PRECISE-AKI are considered safe, but their success in improving health outcomes can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRECISE-AKI Clinical Decision Support Tool because it offers a novel approach to managing kidney failure. Unlike traditional treatments that rely heavily on physician judgment and standard protocols, this tool uses advanced diagnostic support to provide personalized decision-making assistance. It aims to enhance the precision of treatment by analyzing patient-specific data in real-time, potentially improving patient outcomes and reducing the incidence of acute kidney injury. By integrating cutting-edge technology into clinical practice, the tool represents a significant shift toward more tailored and data-driven kidney care.

What evidence suggests that the PRECISE-AKI tool is effective for diagnosing acute kidney injury?

Studies have shown that clinical decision support systems (CDSS) can enhance the diagnosis and care of acute kidney injury (AKI). AKI, a sudden loss of kidney function, affects up to 20% of hospitalized Veterans. This trial tests the PRECISE-AKI tool as an intervention to provide doctors with timely and useful information for diagnosing AKI. Research indicates that such tools can alter doctors' responses to AKI, potentially improving patient care. Although not all electronic alert systems have improved outcomes like kidney function, they have influenced healthcare provider behavior, marking progress toward better management of the condition. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael E Matheny, MD MS MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Edward D Siew, MD MSc

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Are You a Good Fit for This Trial?

This trial is for hospitalized veterans who are experiencing acute kidney injury (AKI). It aims to help those in need of timely and accurate diagnosis to start appropriate treatments. Specific eligibility criteria details were not provided.

Inclusion Criteria

Eligible providers will have at least 4 weeks of inpatient ward team or consultation team activity during a 12-month period

I have been hospitalized for a moderate to persistent mild kidney injury.

Exclusion Criteria

Ineligible providers will have less than 4 weeks of inpatient ward team or consultative team activity during a 12-month period

I was hospitalized for a minor injury that lasted less than 48 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive diagnostic evaluation support using the PRECISE-AKI tool or usual care

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• PRECISE-AKI Clinical Decision Support Tool

Trial Overview The study is testing a new tool called PRECISE-AKI, which uses rules and artificial intelligence to support doctors in diagnosing the type of AKI quickly and accurately, potentially improving initial evaluations.

How Is the Trial Designed?

Group I: PRECISION AKI Clinical Decision Support Experimental Treatment 1 Intervention

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

Group II: Control (Usual Care) Active Control 1 Intervention

The Control arm will consist of usual care with no additional clinical decision support tool guidance

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

VA Tennessee Valley Health Care System

Collaborator

Trials

5

Recruited

1,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217808?aggFilters=status%3A

Precision-Medicine Diagnostic Support in Hospitalized ... Acute kidney injury (AKI), defined as a sudden loss of kidney function, affects up to 20% of hospitalized Veterans and is strongly associated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6165685/

AKI In Realtime: Prediction, Alerts, and Clinical Decision Support In this review, we discuss the current state-of-the-art in EHR-based tools to predict imminent AKI, alert to the presence of AKI, and modify provider behaviors ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001019

Assessments of Generative Artificial Intelligence as Clinical ... Acute kidney injury (AKI), characterized by an acute deterioration in kidney function, occurs in approximately 25% of hospitalized ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2814092

Automated Electronic Alert for the Care and Outcomes of ... Results of this randomized clinical trial showed that the electronic AKI alert did not improve kidney function or other patient-centered outcomes but changed ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07217808

PRECISE-AKI Clinical Decision Support Tool in Acute Kidney ... Exploratory Clinical Outcome: Peak Kidney Disease Improving Global Outcomes (KDIGO) AKI Stage during hospitalization. Time Frame: During Index ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8335454/

Effect of clinical decision support systems on clinical outcome ... Clinical decision support systems including both electronic alerts and care bundles have been developed for hospitalized patients with acute kidney injury.

7. nature.com nature.com/articles/s41467-023-39474-6

Predicting in-hospital outcomes of patients with acute ... Contemporary AI applications can accurately predict the onset of AKI before notable biochemical changes occur and the need for future dialysis ...

8. qualitysafety.bmj.com qualitysafety.bmj.com/content/29/5/382

Implementation of clinical decision support to manage ... An ethnographic study comprising non-participant observation and interviews was conducted in two NHS hospitals, delivering AKI quality improvement programmes.