Clinical trial NCT02660931: Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Official title: Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Renal Injury
Kidney Disease
Keywords: Pediatrics
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 12108
Sex: ALL
Minimum age (years): 28
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Serum Creatinine Tests Ordered
timeFrame: Admission through Discharge (approximately 2 days to 1 week)
Secondary outcomes:
measure: Length of Stay (days)
timeFrame: Admission through Discharge (approximately 2 days to 1 week)
measure: Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)
timeFrame: Admission through Discharge (approximately 2 days to 1 week)
measure: In-hospital Mortality
timeFrame: Admission through Discharge (approximately 2 days to 1 week)
measure: Renal Replacement Therapy (number requiring RRT)
timeFrame: Admission through Discharge (approximately 2 days to 1 week)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sara L Van Driest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: