An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590028
• Other study ID #: IRB17-1081
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Sharon Trevino, RN
• Phone: 773-702-6201
• Email: strevino[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 years old

2. Initial ESTOP AKI score =0.12 within the last 8 hours.

Exclusion Criteria:

1. Voluntary refusal or missing written consent of the patient / legal representative.

2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).

3. Patients without a measured serum creatinine value during their inpatient stay.

4. 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.

5. Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.

6. Patients with prior renal consultation during their admission.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• 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.
• Standard of Care (SOC)
Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences by treatment group in the proportion by percent and time in days to specified medical events.	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.	3 months
Other	Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.	The differences will be measured by treatment group in the proportion by percent and time in days of LOS in the hospital.	3 months
Primary	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