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

Not Applicable

Completed

• Conditions: Renal Injury; Kidney Disease; Acute Kidney Injury
• Interventions: Other: AKI Risk Notification

• Registration Number: NCT02660931
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-18
• Study First Posted: 2016-01-21
• Study Start: 2016-11
• Primary Completion: 2017-11
• Study Completion: 2018-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKI Risk Notification	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States