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
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury Renal Injury Kidney Disease||Other: AKI Risk Notification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- 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.
- 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.
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
|United States, Tennessee|
|Monroe Carell Jr. Children's Hospital at Vanderbilt|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Sara L Van Driest, MD, PhD||Vanderbilt University Medical Center|