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

NCT ID: NCT02660931

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Acute Kidney Injury; Renal Injury; Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

AKI Risk Notification

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sara Van Driest

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara L Van Driest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

130558

Identifier Type: -

Identifier Source: org_study_id