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

NCT02660931 | Completed

• 1 other identifier: 130558
• Study Type: interventional
• Target: 12,108
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Renal Injury; Kidney Disease

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of Stay (days)

  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)

  Admission through Discharge (approximately 2 days to 1 week)

• In-hospital Mortality

  Admission through Discharge (approximately 2 days to 1 week)

• Renal Replacement Therapy (number requiring RRT)

  Admission through Discharge (approximately 2 days to 1 week)

Study Arms (2)

AKI Risk Notification

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

These patients will receive usual clinical care, with no acute kidney injury risk notification.

Interventions

AKI Risk Notification OTHER

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.

AKI Risk Notification

Eligibility Criteria

• Age: 28 Days - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sara L Van Driest, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 21, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)