Recruiting

AI-Powered CDS

Sponsor:

Johns Hopkins University

Code:

NCT06840210

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Acute Kidney Injury

Study ID

NCT06840210

Start date

Mar 10, 2026

Status verified date

Apr, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

200000 participants

Anticipated

Interventions and Outcome Measures

Arms

All adult ED patients with creatinine concentration measured during the participant's ED stay

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Eili Y Klein, PhD

732-266-7732eklein@jhmi.edu

Michael Ehmann, MD

mehmann1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Eili Klein, PhD

732-266-7732eklein@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-20.