NCT03590028

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2018Feb 2027

First Submitted

Initial submission to the registry

June 21, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

8.1 years

First QC Date

June 21, 2018

Last Update Submit

May 8, 2026

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    7-day interval

Other Outcomes (2)

  • Differences by treatment group in the proportion by percent and time in days to specified medical events.

    3 months

  • Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.

    3 months

Study Arms (2)

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.

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.

Other: Standard of Care (SOC)

Interventions

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.

Early Nephrology Consult (ENC)
Standard of Care (SOC)OTHER

Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.

Standard of Care (SOC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Initial ESTOP AKI score ≥0.01 within the last 8 hours.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Koyner 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.

    PMID: 40232856DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jay Koyner, MD

    University of Chicago Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 18, 2018

Study Start

October 1, 2018

Primary Completion (Estimated)

November 6, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)