Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): study protocol for a prospective observational study
Assessment of Worldwide Acute Kidney Injury, Renal Angina and Epidemiology in Critically Ill Children (AWARE): study protocol for a prospective observational study
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DOI：
10.1186/s12882-015-0016-6
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发表时间：
2015-02-26
期刊：
影响因子：
2.3
通讯作者：
Goldstein, Stuart L.
中科院分区：
文献类型：
--
作者：
Basu, Rajit K.;Kaddourah, Ahmad;Goldstein, Stuart L.
背景：急性肾损伤（阿基）与危重患儿的不良结局相关。虽然从儿科人群的回顾性研究中提取的数据表明阿基的发生率很高，但文献缺乏描述阿基风险因素、流行病学和结局的集中和全面的多中心研究。此外，很少有儿科研究探讨了新的尿生物标志物体外循环population.Methods/设计：这是一个前瞻性的观察性研究。我们预计在2014年收集全球31个儿科重症监护室（PICU）收治的5000多名危重儿童的数据。将收集所有年龄大于90天且小于25岁的儿童的数据，这些儿童没有基线5期慢性肾脏疾病、慢性肾脏替代治疗，并且在肾移植或先天性心脏病手术矫正后90天之外。收集的数据包括人口统计学信息、入院诊断和合并症，以及所用液体和血管活性复苏的详细信息。将结合风险因素和血清肌酐和液体超负荷的早期变化计算肾性心绞痛指数。在第2-7天，将采集所有血流动力学和相关实验室值，重点关注阿基相关值。每日计算值将包括液体超负荷%、液体校正肌酐和KDIGO阿基分期。在入院第0-3天，每天采集两次尿液用于生物标志物分析。待测量的生物标志物包括中性粒细胞明胶酶脂质运载蛋白（NGAL）、肾损伤分子-1（KIM-1）、肝型脂肪酸结合蛋白（I-FABP）和白细胞介素-18（IL-18）。要量化的主要结局是第3天重度阿基的发生率（第3天-阿基）。将分析通过RAI和将生物标志物与RAI结合后对第3天阿基的预测。全球急性肾损伤、肾心绞痛和流行病学评估（AWARE）研究创建了第一个前瞻性国际儿科全因阿基数据仓库和生物样本储存库，为寻求研究风险因素、预测、识别、和治疗选择的疾病综合征与高相关的发病率影响住院儿童的显着比例。
Background: Acute 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/Design: This 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 (I-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.Discussion: The 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.