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Algorithm

Early Nephrology Intervention for Acute Kidney Injury (ESTOP-AKI Trial)

N/A
Waitlist Available
Led By Jay Koyner, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years old
Be older than 18 years old
Must not have
Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
Voluntary refusal or missing written consent of the patient / legal representative.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if an AKI risk score can help improve patient outcomes by providing an early, standard nephrology intervention.

Who is the study for?
This trial is for adults over 18 who have a risk of acute kidney injury (AKI) as indicated by an ESTOP AKI score ≥0.12. It's not open to those with end-stage renal disease, high creatinine levels at admission, previous AKI episodes or renal consultations during the same hospital stay.
What is being tested?
The study tests if an automated real-time electronic health record risk score can improve outcomes in patients at risk of AKI through early intervention from kidney specialists compared to standard care.
What are the potential side effects?
Since this trial compares standard medical care with early specialist consultation, side effects are not directly related to new medications but may include potential risks associated with any changes in treatment following nephrology advice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a kidney injury during this hospital stay.
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I have not refused or failed to provide written consent.
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I have end-stage kidney disease and am on dialysis or have had a kidney transplant.
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My creatinine level was over 4.0 mg/dl in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
Other study objectives
Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.
Differences by treatment group in the proportion by percent and time in days to specified medical events.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Nephrology Consult (ENC)Experimental Treatment1 Intervention
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.
Group II: Standard of Care (SOC)Active Control1 Intervention
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,729 Total Patients Enrolled
Jay Koyner, MDPrincipal InvestigatorUniversity of Chicago Medicine
2 Previous Clinical Trials
811 Total Patients Enrolled

Media Library

Automated AKI Risk Score (Algorithm) Clinical Trial Eligibility Overview. Trial Name: NCT03590028 — N/A
Acute Kidney Failure Research Study Groups: Early Nephrology Consult (ENC), Standard of Care (SOC)
Acute Kidney Failure Clinical Trial 2023: Automated AKI Risk Score Highlights & Side Effects. Trial Name: NCT03590028 — N/A
Automated AKI Risk Score (Algorithm) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03590028 — N/A
~25 spots leftby Nov 2025