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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 belowSelect...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a kidney injury during this hospital stay.
Select...
I have not refused or failed to provide written consent.
Select...
I have end-stage kidney disease and am on dialysis or have had a kidney transplant.
Select...
My creatinine level was over 4.0 mg/dl in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
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
1,062 Previous Clinical Trials
839,956 Total Patients Enrolled
Jay Koyner, MDPrincipal InvestigatorUniversity of Chicago Medicine
2 Previous Clinical Trials
811 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a kidney injury during this hospital stay.I have seen a kidney specialist during my hospital stay.I have not refused or failed to provide written consent.You have a high risk for developing acute kidney injury based on a recent test score.I am older than 18 years.You have not had your serum creatinine level checked while in the hospital.I have end-stage kidney disease and am on dialysis or have had a kidney transplant.My creatinine level was over 4.0 mg/dl in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Early Nephrology Consult (ENC)
- Group 2: Standard of Care (SOC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.