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

Not Applicable

Active, not recruiting

• Conditions: Acute Kidney Injury

• Registration Number: NCT03590028
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-05
• Study First Posted: 2018-07-18
• Study Start: 2018-10-01
• Primary Completion: 2024-09-06
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-15
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age >18 years old
2. Initial ESTOP AKI score ≥0.01 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval	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.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States