Acute Kidney InjurySMART-AKINCT06840210
Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support
An observational study of Acute Kidney Injury, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to 1 Dec 2030
- How long will I take part?
- 365 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Ehmann, MD contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Eili Klein, PhD, 732-266-7732, eklein@jhmi.edu
About this study
Official title: Transforming Kidney Care in the Emergency Department: A Prospective Effectiveness-Implementation Evaluation
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:
Read more
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
- Keywords
- Acute Kidney Injury, AKI, Prediction, Machine Learning, Emergency Department, Clinical Decision Support
- Medical subject headings
- Acute Kidney Injury, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All adult ED patients with creatinine concentration measured during the participant's ED stay | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who receive Guideline-Concordant Kidney Care
Measured: From time of decision support provision until departure from the ED, approximately 6 hours
Secondary outcomes (2)
New or Progressive Acute Kidney Injury
Measured: Within 72 hours of first creatinine measurement in the ED
Perceived usefulness and usability of AKIDS software as assessed by the System Usability Score
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.
Measured: Prior to AKIDS implementation, immediately after implementation, and post implementation 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start10 Mar 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Eili Klein, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840210
- Sponsor's protocol ID
- IRB00367884
- Other IDs
- R01HS027793
- Acronym
- SMART-AKI
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Kidney Care in the Emergency Department: A Prospective Effectiveness-Implementation Evaluation
- ClinicalTrials.gov ID
- NCT06840210
- Acronym / sponsor ID
- SMART-AKI / IRB00367884
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, AKI, Prediction, Machine Learning, Emergency Department, Clinical Decision Support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All adult ED patients with creatinine concentration measured during the participant's ED stay | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department
Key inclusion criteria (7 listed)
- Emergency Department Visit
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
New or Progressive Acute Kidney Injury
Time frame: Within 72 hours of first creatinine measurement in the ED
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Ehmann, MD contact
Eili Klein, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eili Y Klein, PhD (732-266-7732, eklein@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.