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

Acute Kidney Injury Clinical Trial

— PAR4  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660931
• Other study ID #: 130558
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12108
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Disease
• Kidney Diseases
• Renal Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Stay (days)	Number of days in hospital for admission.	Admission through Discharge (approximately 2 days to 1 week)
Secondary	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)
Secondary	In-hospital Mortality	If any in cohort.	Admission through Discharge (approximately 2 days to 1 week)
Secondary	Renal Replacement Therapy (number requiring RRT)	Determined by ICD10 and CPT codes during admission.	Admission through Discharge (approximately 2 days to 1 week)