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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: Early Nephrology Consult (ENC)
* Other: Standard of Care (SOC)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Nephrology Consult (ENC)<br>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. | Other: Early Nephrology Consult (ENC)<br>* 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.<br>|
| Active Comparator: Standard of Care (SOC)<br>Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear. | Other: Standard of Care (SOC)<br>* Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |