Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): study protocol for a prospective observational study

Abstract

BackgroundAcute kidney injury (AKI) is associated with poor outcome in critically ill children. While data extracted from retrospective study of pediatric populations demonstrate a high incidence of AKI, the literature lacks focused and comprehensive multicenter studies describing AKI risk factors, epidemiology, and outcome. Additionally, very few pediatric studies have examined novel urinary biomarkers outside of the cardiopulmonary bypass population.Methods/DesignThis is a prospective observational study. We anticipate collecting data on over 5000 critically ill children admitted to 31 pediatric intensive care units (PICUs) across the world during the calendar year of 2014. Data will be collected for seven days on all children older than 90 days and younger than 25 years without baseline stage 5 chronic kidney disease, chronic renal replacement therapy, and outside of 90 days of a kidney transplant or from surgical correction of congenital heart disease. Data to be collected includes demographic information, admission diagnoses and co-morbidities, and details on fluid and vasoactive resuscitation used. The renal angina index will be calculated integrating risk factors and early changes in serum creatinine and fluid overload. On days 2–7, all hemodynamic and pertinent laboratory values will be captured focusing on AKI pertinent values. Daily calculated values will include % fluid overload, fluid corrected creatinine, and KDIGO AKI stage. Urine will be captured twice daily for biomarker analysis on Days 0–3 of admission. Biomarkers to be measured include neutrophil gelatinase lipocalin (NGAL), kidney injury molecule-1 (KIM-1), liver-type fatty acid binding protein (l-FABP), and interleukin-18 (IL-18). The primary outcome to be quantified is incidence rate of severe AKI on Day 3 (Day 3 – AKI). Prediction of Day 3 – AKI by the RAI and after incorporation of biomarkers with RAI will be analyzed.DiscussionThe Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology (AWARE) study, creates the first prospective international pediatric all cause 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.Trial registrationClinicalTrials.gov: NCT01987921Electronic supplementary materialThe online version of this article (doi:10.1186/s12882-015-0016-6) contains supplementary material, which is available to authorized users.

The biomarkers for acute kidney injury: A clear road ahead?

“…Using biomarkers to aid in the selection of a higher-risk patient group for a study could lead to a focus on those more likely to benefit from an intervention. [18,19] In the recent ELAIN trial, KDIGO classification combined with plasma NGAL (>150 ng/dL) was used to randomize patients for early versus late RRT. Similarly, the use of enrichment is also important clinically since efforts to improve clinical outcomes will be most effective when focused on the highest-risk groups.…”

Día Mundial del Riñón 2016. Prevención del legado de la nefropatía, con enfoque en la niñez

“…Los resultados de proyectos como el estudio AWARE, estudio sobre lesión renal aguda llevado a cabo en niños en cinco países, aún están pendientes. 13 Los estudios unicéntricos, además de los metanálisis, indican que tanto la lesión renal aguda como la IRC en niños representan una minoría entre los casos de IRC a nivel mundial. 2,3 No obstante, es cada vez más evidente que la nefropatía adulta suele originarse en la infancia.…”

Pediatric acute kidney injury: prevalence, impact and management challenges

“…10 As part of the assessment of AKI risk, the renal angina index (RAI), which will be described in more detail later in this review, was validated in this international population.…”