Acute Kidney InjuryESTOP-AKINCT03590028
An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury
A study testing Early Nephrology Consult (ENC) in people with Acute Kidney Injury, run by University of Chicago at 1 site in United States.
Trial summary
This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Early Nephrology Consult (ENC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 28 Feb 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years old
- Initial ESTOP AKI score ≥0.01 within the last 8 hours.
Who cannot join
- Voluntary refusal or missing written consent of the patient / legal representative.
- Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
- Patients without a measured serum creatinine value during their inpatient stay.
- Patients with a creatinine >4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
- Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
- Patients with prior renal consultation during their admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention
This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.
- Conditions
- Acute Kidney Injury
- Being tested
- Early Nephrology Consult (ENC), Standard of Care (SOC)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Nephrology Consult (ENC)Other
The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization.
Standard of Care (SOC)Other
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
| Study group | Role | What they receive |
|---|---|---|
| Early Nephrology Consult (ENC) | Experimental | The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations. Receives: Other: Early Nephrology Consult (ENC) |
| Standard of Care (SOC) | Active comparator | Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups.
Measured: 7-day interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Oct 2018
- Primary completion6 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Koyner, MD, Principal investigator, University of Chicago Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590028
- Sponsor's protocol ID
- IRB17-1081
- Acronym
- ESTOP-AKI
- Status last verified
- May 2026
- First submitted
- 21 Jun 2018
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Churpek MM, Fatima A, Anjorin O, Saravanan A, Ko BS, Gunning S, Prochaska ML, Puri TS, Zisman AL, Edelson DP, Giurcanu MC, Koyner JL; Electronic Signal to Prevent Acute Kidney Injury (ESTOP-AKI) Investigative Team. Early Nephrology Consultation and Acute Kidney Injury in Hospitalized Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2622554. doi: 10.1001/jamanetworkopen.2026.22554.
PubMed 42430171Koyner JL, Martin J, Carey KA, Caskey J, Edelson DP, Mayampurath A, Dligach D, Afshar M, Churpek MM. Multicenter Development and Validation of a Multimodal Deep Learning Model to Predict Moderate to Severe AKI. Clin J Am Soc Nephrol. 2025 Apr 15;20(6):766-778. doi: 10.2215/CJN.0000000695.
PubMed 40232856
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention
- ClinicalTrials.gov ID
- NCT03590028
- Acronym / sponsor ID
- ESTOP-AKI / IRB17-1081
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Jul 2018 (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.
This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Nephrology Consult (ENC) | Experimental | Other: Early Nephrology Consult (ENC)The ENC will be a structured consultative note that will provide detailed recommendations around issues such as Differential Diagnosis, Drug Dosing and Volume Status. The research ENC will have a daily follow-up with documented recommendations. |
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC)Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years old
- Initial ESTOP AKI score ≥0.01 within the last 8 hours.
Key exclusion criteria (6 listed)
- Voluntary refusal or missing written consent of the patient / legal representative.
- Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
- Patients without a measured serum creatinine value during their inpatient stay.
- Patients with a creatinine >4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
- Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Nephrology Consult (ENC)The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization. | Other | Early Nephrology Consult (ENC) |
| Standard of Care (SOC)Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. | Other | Standard of Care (SOC) |
Primary outcome
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
Time frame: 7-day interval
The primary endpoint of interest, change in serum creatinine (SCr), is the peak change from study entry in SCr level over a 7-day interval. The change in SCr is defined as the maximal change in creatinine over this interval, and aim to detect a clinical difference in change in SCr between the SOC and ENC treatment groups.
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 11 May 2026.
- Derived from this study: PubMed 42430171Churpek MM, Fatima A, Anjorin O, Saravanan A, Ko BS, Gunning S, Prochaska ML, Puri TS, Zisman AL, Edelson DP, Giurcanu MC, Koyner JL; Electronic Signal to Prevent Acute Kidney Injury (ESTOP-AKI) Investigative Team. Early Nephrology Consultation and Acute Kidney Injury in Hospitalized Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2622554. doi: 10.1001/jamanetworkopen.2026.22554.
- Derived from this study: PubMed 40232856Koyner JL, Martin J, Carey KA, Caskey J, Edelson DP, Mayampurath A, Dligach D, Afshar M, Churpek MM. Multicenter Development and Validation of a Multimodal Deep Learning Model to Predict Moderate to Severe AKI. Clin J Am Soc Nephrol. 2025 Apr 15;20(6):766-778. doi: 10.2215/CJN.0000000695.
- 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. This study is not recruiting at the moment.
Jay Koyner, MD principal investigator
University of Chicago Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Nephrology Consult (ENC) in people with Acute Kidney Injury, run by University of Chicago 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval (time frame: 7-day interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590028, which also lists 2 linked publications.
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 11 May 2026.