Back to resultsAn Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Nephrology Consult (ENC)
Standard of Care (SOC)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Age >18 years old
- Initial ESTOP AKI score ≥0.12 within the last 8 hours.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Chicago Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Nephrology Consult (ENC)
Standard of Care (SOC)
Arm Description
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.
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03590028
Brief Title
An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Nephrology Consult (ENC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
Intervention Type
Other
Intervention Name(s)
Early Nephrology Consult (ENC)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
Primary Outcome Measure Information:
Title
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
Description
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.
Time Frame
7-day interval
Other Pre-specified Outcome Measures:
Title
Differences by treatment group in the proportion by percent and time in days to specified medical events.
Description
The differences will be measured by treatment group in the proportion and time to event of patients who a) develop > Stage 2 AKI, b) require renal replacement therapy (RRT), c) undergo intensive care unit (ICU) transfer, and/or d) require non-research nephrology consult.
Time Frame
3 months
Title
Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.
Description
The differences will be measured by treatment group in the proportion by percent and time in days of LOS in the hospital.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years old
Initial ESTOP AKI score ≥0.12 within the last 8 hours.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Trevino, RN
Phone
773-702-6201
Email
strevino@medicine.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Koyner, MD
Organizational Affiliation
University of Chicago Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Trevino
Email
strevino@bsd.uchicago.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury
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