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NCT Number: NCT06840210

Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support

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.

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Key information

Conditions

Acute Kidney Injury Disease Attributes Emergencies Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Eili Klein, PhD

CONTACT

[email protected]

732-266-7732

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet all of the following conditions to be eligible for the study:

  • 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

  • At least one serum creatinine (sCr) test performed during the ED visit.
  • Age: Adults (≥18 years old) at the time of ED visit.
  • 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

  • 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.
  • 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.
  • Age <18 Years
  • 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).

Treatment and study plan

Primary outcomes

  1. Number of Patients who receive Guideline-Concordant Kidney Care

    Time frame: From time of decision support provision until departure from the ED, approximately 6 hours

Secondary outcomes

  1. New or Progressive Acute Kidney Injury

    Time frame: Within 72 hours of first creatinine measurement in the ED

  2. Perceived usefulness and usability of AKIDS software as assessed by the System Usability Score

    Time frame: Prior to AKIDS implementation, immediately after implementation, and post implementation 6 months

    Will 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eili Y Klein, PhD

CONTACT

[email protected]

732-266-7732

Michael Ehmann, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Agency For Healthcare Research & Quality

Registry information

Official study title

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

Acronym: SMART-AKI

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 21, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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