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OpenTrials
Completed

NCT Number: NCT02660931

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

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.

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Key information

Age range

28 day–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: PAR4

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 21, 2016
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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