search
Back to results

Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research (PAR4)

Primary Purpose

Acute Kidney Injury, Renal Injury, Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AKI Risk Notification
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Acute Kidney Injury focused on measuring Pediatrics

Eligibility Criteria

28 Days - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AKI Risk Notification

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of Serum Creatinine Tests Ordered
Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.

Secondary Outcome Measures

Length of Stay (days)
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)
Worst stage of AKI during hospital stay.
In-hospital Mortality
If any in cohort.
Renal Replacement Therapy (number requiring RRT)
Determined by ICD10 and CPT codes during admission.

Full Information

First Posted
January 18, 2016
Last Updated
April 1, 2019
Sponsor
Vanderbilt University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02660931
Brief Title
Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Acronym
PAR4
Official Title
Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Renal Injury, Kidney Disease
Keywords
Pediatrics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
12108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKI Risk Notification
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
These patients will receive usual clinical care, with no acute kidney injury risk notification.
Intervention Type
Other
Intervention Name(s)
AKI Risk Notification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Serum Creatinine Tests Ordered
Description
Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.
Time Frame
Admission through Discharge (approximately 2 days to 1 week)
Secondary Outcome Measure Information:
Title
Length of Stay (days)
Description
Number of days in hospital for admission.
Time Frame
Admission through Discharge (approximately 2 days to 1 week)
Title
Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3)
Description
Worst stage of AKI during hospital stay.
Time Frame
Admission through Discharge (approximately 2 days to 1 week)
Title
In-hospital Mortality
Description
If any in cohort.
Time Frame
Admission through Discharge (approximately 2 days to 1 week)
Title
Renal Replacement Therapy (number requiring RRT)
Description
Determined by ICD10 and CPT codes during admission.
Time Frame
Admission through Discharge (approximately 2 days to 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara L Van Driest, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs