NCT07217808

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Jan 2028

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

October 6, 2025

Last Update Submit

October 15, 2025

Conditions

Acute Kidney Injury (AKI)

Keywords

Acute Kidney InjuryDecision Support Systems, ClinicalArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • 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 AKI case definition

    Up to 30 days

Other Outcomes (3)

  • Exploratory Clinical Outcome: Peak Kidney Disease Improving Global Outcomes (KDIGO) AKI Stage during hospitalization.

    During Index Hospitalization through 30 days

  • Exploratory Clinical Outcome: Discharge serum creatinine

    Last serum creatinine during index hospitalization through 30 days

  • Exploratory Clinical Outcome: Major Adverse Kidney Events (MAKE) 90

    90 days

Study Arms (2)

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

Other: PRECISE-AKI Clinical Decision Support Tool

Interventions

PRECISE-AKI Clinical Decision Support ToolOTHER

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

PRECISION AKI Clinical Decision Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward D Siew, MD MSc

CONTACT

(615) 343-1279Edward.siew@va.gov

Michael E Matheny, MD MS MPH

CONTACT

(615) 936-0090Michael.Matheny@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is not possible to blind clinicians. Study data will be extracted by staff blinded to assignment.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Pre-/Post- design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2025

First Posted

October 16, 2025

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)