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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE January 21, 2016
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
Number of Serum Creatinine Tests Ordered [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • Length of Stay (days) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    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) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    Worst stage of AKI during hospital stay.
  • In-hospital Mortality [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
    If any in cohort.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
  • Length of Stay (days) [ Time Frame: 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) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
  • In-hospital Mortality [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
  • Renal Replacement Therapy (number requiring RRT) [ Time Frame: Admission through Discharge (approximately 2 days to 1 week) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Official Title  ICMJE Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Condition  ICMJE
  • Acute Kidney Injury
  • Renal Injury
  • Kidney Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: AKI Risk Notification
  • No Intervention: Usual Care
    These patients will receive usual clinical care, with no acute kidney injury risk notification.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2017)
12108
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2016)
10000
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02660931
Other Study ID Numbers  ICMJE 130558
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sara Van Driest, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sara L Van Driest, MD, PhD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP