Skip to content

Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support

Transforming Kidney Care in the Emergency Department: A Prospective Effectiveness-Implementation Evaluation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06840210
Acronym
SMART-AKI
Enrollment
200000
Registered
2025-02-21
Start date
2026-03-10
Completion date
2030-12-01
Last updated
2026-04-20

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

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, AKI, Prediction, Machine Learning, Emergency Department, Clinical Decision Support

Brief summary

Study Purpose: This study is testing an artificial intelligence (AI)-powered clinical decision support (CDS) system designed to help emergency department (ED) doctors detect and manage acute kidney injury (AKI) earlier. The goal is to see whether the tool improves patient care, clinician decision-making, and hospital outcomes when used in real-world ED settings. Study Design: The AI tool will be gradually introduced at three hospital EDs: Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH) Before the tool is activated, it will run in the background to collect baseline data without influencing care. Once implemented, doctors will receive training, and researchers will track how often the tool is used and whether it improves AKI care. What the Study Measures: Process Outcomes: Does the tool help doctors identify AKI sooner, avoid harmful medications, and improve decision-making about hospitalization? Clinical Outcomes: Does the tool reduce the number and severity of AKI cases and improve kidney-related health outcomes? Implementation Outcomes: Do ED doctors find the tool useful? Does it fit into the ED doctor's workflow without slowing the ED doctor's down? Expected Impact: If successful, the AI tool could be expanded to other hospitals and used to improve early detection and treatment of AKI, reducing kidney complications and improving patient care nationwide.

Interventions

None listed

Sponsors

Johns Hopkins University
Lead SponsorOTHER
Agency For Healthcare Research & Quality
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

Participants must meet all of the following conditions to be eligible for the study: 1. Emergency Department Visit Patients presenting to one of the three study site emergency departments (EDs): Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH) Serum Creatinine Measurement 2. At least one serum creatinine (sCr) test performed during the ED visit. 3. Age: Adults (≥18 years old) at the time of ED visit. 4. Follow-Up Data Available: To be included in analysis for the investigator's secondary effectiveness outcome (new or progressive AKI) patients must have repeat creatinine concentration measurement available within 72 hours

Exclusion criteria

1. No ED Serum Creatinine Data: Patients who do not have a measured serum creatinine (sCr) value during the ED visit will not have decision support provided during the ED stay. 2. Patients Discharged Without Follow-Up Data: Patients discharged from the ED who do not undergo a follow-up serum creatinine test within 72 hours will be excluded from analysis of new or progressive AKI outcome assessment. 3. Age \<18 Years 4. End-Stage Kidney Disease (ESKD) or Chronic Dialysis: Patients with a documented history of end-stage kidney disease (ESKD), (patients receiving chronic dialysis (hemodialysis or peritoneal dialysis) will will be excluded from analysis of new or progressive AKI outcome assessment).

Design outcomes

Primary

MeasureTime frame
Number of Patients who receive Guideline-Concordant Kidney CareFrom time of decision support provision until departure from the ED, approximately 6 hours

Secondary

MeasureTime frameDescription
New or Progressive Acute Kidney InjuryWithin 72 hours of first creatinine measurement in the ED
Perceived usefulness and usability of AKIDS software as assessed by the System Usability ScorePrior to AKIDS implementation, immediately after implementation, and post implementation 6 monthsWill be assessed using the usability using the System Usability Score, a 10-item Likert scale that yields a single composite score on a scale of 0-100, with 100 being most usable.

Countries

United States

Contacts

CONTACTEili Y Klein, PhD
eklein@jhmi.edu732-266-7732
CONTACTMichael Ehmann, MD
mehmann1@jhmi.edu
PRINCIPAL_INVESTIGATOREili Klein, PhD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026