alexa Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): A Prospective Study to Improve Diagnostic Precision | Abstract
ISSN: 2167-0870

Journal of Clinical Trials
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Protocol

Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): A Prospective Study to Improve Diagnostic Precision

Rajit K Basu1*, Ahmad Kaddourah1, Tara Terrell1, Theresa Mottes1, Patricia Arnold1, Judd Jacobs2, Jennifer Andringa2, Melissa Armor2, Lauren Hayden2 and Stuart L Goldstein1(on behalf of the Prospective Pediatric AKI Research Group (ppAKI-RG))
1Center for Acute Care Nephrology, Cincinnati Children’s Hospital and Medical Center, University of Cincinnati, USA
2Division of Biostatistics and Epidemiology, Cincinnati Children’s Hospital and Medical Center, University of Cincinnati, USA
Corresponding Author : Rajit K Basu, M.D.
Center for Acute Care Nephrology
Cincinnati Children’s Hospital and Medical Center
3333 Burnet Avenue, Division of Critical Care
ML 2005, Cincinnati, OH 45229, USA
Tel: (513)-636-4529
Fax: (513)-636-4267
E-mail: [email protected]
Received December 31, 2014; Accepted April 15, 2015; Published April 17, 2015
Citation: Basu RK, Kaddourah A, Terrell T, Mottes T, Arnold P, et al. (2015) Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): A Prospective Study to Improve Diagnostic Precision . J Clin Trials 5:222. doi:10.4172/2167-0870.1000222
Copyright: © 2015 Basu RK, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Background: Acute kidney injury (AKI) is associated with poor outcomes in critically ill children. Recent international consensus panels recommend standardized classification systems to improve the precision of AKI diagnosis, but there is a paucity of data to enable this refinement, particularly in pediatric critical care.

Methods/Design: This is a prospective observational study. We anticipate collecting data from more than 5500 critically ill children admitted to 32 pediatric intensive care units (PICUs) across the world, during the calendar year of 2014. Data will be collected continuously for three months at each center on all children older than 90 days and younger than 25 years admitted to the ICU. Demographic, resuscitative, and daily physiological and lab data will be captured at individual centers using MediData Rave™, a commercial system designed to manage and report clinical research data. Kidney specific measured variables include changes in serum creatinine and urine output, cumulative fluid overload (%), serum creatinine corrected for fluid balance, and KDIGO AKI stage. Urinary AKI biomarkers to be measured include: urinary neutrophil gelatinase lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (l-FABP), and interleukin-18 (IL-18). Biomarker combinations will be created from different pairs and triplets of urinary biomarkers. The primary analysis will compare the discrimination of these panels versus changes in creatinine for prediction of severe AKI by Day 7 of ICU admission. Secondary analysis will investigate the prediction of biomarkers for injury ‘time based phenotypes’: duration (>2 days), severity (KDIGO stage, use of renal replacement therapy), reversibility (time to return of serum creatinine to baseline), association with fluid overload > 10%, and disease association (sepsis, hypovolemia, hypoxemia, or nephrotoxic).

Discussion: The Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) study will be the largest ever prospective study of any disease process in pediatric critical care. Data from AWARE will enable refinement of AKI classification. AWARE creates the largest ever all-cause pediatric AKI data warehouse and biologic sample repository, providing a broad and invaluable resource for critical care nephrologists seeking to study risk factors, prediction, identification, and treatment options for a disease syndrome with high associated morbidity affecting a significant proportion of hospitalized children. Improving the precision of AKI diagnosis using biomarker combinations provides a foundation for targeted, personalized therapy for different injury phenotypes.

Trial registration number: NCT01987921.

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