Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research (PAR4)

This proposal will incorporate statistical models developed by the investigators to predict risk for acute kidney injury into our electronic medical record system, enabling an alert to notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, who will receive usual care (no notification). The investigators believe the notification will increase appropriate screening for acute kidney injury and reduce the severity of acute kidney injury in the intervention group.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Kidney Disease; Renal Injury
• Intervention / Treatment: Other: AKI Risk Notification

Detailed Description

This proposal will incorporate a logistic regression models developed by the investigators to predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward patients into the electronic medical record system, enabling personalized decision support. Real-time surveillance using the risk prediction models will identify pediatric inpatients at increased risk for acute kidney injury. When patients exceed the threshold risk for acute kidney injury, the electronic medical record system will notify providers. Patients will be randomly assigned to be in the intervention group, for whom the notification will be implemented, or in the control group, for whom the notification will not display. The risk notification will be assessed for its impact on outcomes including rates of screening for acute kidney injury and the severity of acute kidney injury.

• Study Type: Interventional
• Enrollment (Actual): 12108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All admissions to the pediatric intensive care unit or pediatric wards at the Monroe Carell Junior Children's Hospital at Vanderbilt

Exclusion Criteria:

• Prior diagnosis of chronic renal disease, including dialysis and transplant
• Admission to the Neonatal Intensive Care Unit during the current admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKI Risk Notification; Patients randomized to this arm will be eligible for an acute kidney injury risk notification, if their calculated risk exceeds the threshold during their inpatient encounter.	Other: AKI Risk Notification; When a patient's calculated acute kidney injury risk exceeds the threshold value, the electronic medical record will notify the provider of the risk and that appropriate screening (BMP including serum creatinine) may be indicated.
No Intervention: Usual Care; These patients will receive usual clinical care, with no acute kidney injury risk notification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Serum Creatinine Tests Ordered	Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.	Admission through Discharge (approximately 2 days to 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (days)	Number of days in hospital for admission.	Admission through Discharge (approximately 2 days to 1 week)
Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)	Worst stage of AKI during hospital stay.	Admission through Discharge (approximately 2 days to 1 week)
In-hospital Mortality	If any in cohort.	Admission through Discharge (approximately 2 days to 1 week)
Renal Replacement Therapy (number requiring RRT)	Determined by ICD10 and CPT codes during admission.	Admission through Discharge (approximately 2 days to 1 week)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Sara L Van Driest, MD, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pediatrics
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 130558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO