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

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ClinicalTrials.gov Identifier: NCT02660931
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Van Driest, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Renal Injury Kidney Disease Other: AKI Risk Notification Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Actual Study Start Date : November 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Usual Care
These patients will receive usual clinical care, with no acute kidney injury risk notification.



Primary Outcome Measures :
  1. Number of Serum Creatinine Tests Ordered [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    Measure of efficacy of the clinical decision support to lead to increased screening for acute kidney injury.


Secondary Outcome Measures :
  1. Length of Stay (days) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    Number of days in hospital for admission.

  2. Acute Kidney Injury Severity (as measured by Kidney Disease Improving Global Outcomes [KDIGO] stage 1, 2 or 3) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    Worst stage of AKI during hospital stay.

  3. In-hospital Mortality [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    If any in cohort.

  4. Renal Replacement Therapy (number requiring RRT) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    Determined by ICD10 and CPT codes during admission.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660931


Locations
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United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Sara L Van Driest, MD, PhD Vanderbilt University Medical Center
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Responsible Party: Sara Van Driest, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02660931    
Other Study ID Numbers: 130558
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sara Van Driest, Vanderbilt University Medical Center:
Pediatrics
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Wounds and Injuries
Urologic Diseases
Renal Insufficiency