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

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Other: Standard of Care (SOC); Other: Early Nephrology Consult (ENC)

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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
• Status Verified: 2024-05
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC)	Standard of Care (SOC)	Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
Early Nephrology Consult (ENC)	Early Nephrology Consult (ENC)	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.

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