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临床试验/NCT01735162
NCT01735162已完成不适用

Prospective Study of Acute Kidney Injury in Critically Ill Children Predicted by Renal Angina and Urinary Biomarkers

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
1
主要终点
Acute kidney injury

研究概览

简要总结

Acute kidney injury (AKI) is a common clinical event with severe consequences. In the pediatric intensive care unit (PICU), AKI occurs in almost 10% of all patients and evidence suggests that children are dying not just with AKI, but from AKI. Unfortunately, the treatment for AKI is limited to a great extent by delayed diagnosis. Reliance on markers of kidney injury that change only when significant damage has already occurred has rendered potential therapies ineffective. For this reason, identification of new markers of AKI that change early in the course of injury is paramount. While new AKI biomarkers have been identified, their performance in the general PICU population is variable. The investigators recently proposed the concept of 'renal angina' as a way to risk stratify patients in the ICU for AKI risk. In the AKI-CHERUB study, the investigators propose to study renal angina in PICU patients alone and in combination with urinary biomarkers for AKI prediction. The investigators hypothesize that renal angina will increase the predictive precision of urinary biomarkers for AKI.

详细描述

Reliance on serum creatinine and urine output for diagnosis of acute kidney injury (AKI) has limited the ability of potential therapeutic measures to be effective. The investigators' recent proposition of the renal angina construct aims to improve and expedite AKI diagnosis through use of risk stratification. An apt parallel is the profound outcome change that has been effected in acute coronary syndrome through targeted troponin measurements in patients with both risk factors and clinical symptoms of coronary ischemia. Novel AKI biomarkers will struggle to gain widespread use until their performance in patients of varying degrees of AKI risk can be balanced with their cost and availability. The investigators hypothesize risk stratification using renal angina (ANG) identifies children at-risk vs. not at-risk for AKI, focusing subsequent biomarker measurement to "rule out" AKI only in children with ANG, increasing biomarker predictive precision. This study is significant because it represents the next step in the vertical integration of AKI biomarkers into routine clinical practice to guide their use rationally. The identification of at-risk patients to guide appropriate biomarker use is high-impact because it will make implementation of preventive and supportive therapies for AKI more effective; data from this study would serve to provide the indications to the Food and Drug Administration (FDA) for biomarker use in critically ill children. The study is innovative because it is the first prospective attempt to study the predictive performance of biomarkers AKI in the PICU population using ANG stratification. The investigators will observe all children admitted to the PICU with an expected length of stay > 48 hours. Urine will be collected from these children and levels of neutrophil gelatinase associated lipocalin (NGAL), interleukin-18 (IL-18), liver-fatty acid binding protein (l-FABP), and kidney injury molecule-1 (KIM-1) will be measured. Renal angina will be assessed at time of admission. Primary outcome will be presence of AKI (as measured by Kidney Diseases Improving Global Outcome (KDIGO) Class 2 or greater) at hospital day 3.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Minimum stay 48 hours
  • Indwelling urinary catheter

排除标准

  • History of renal disease

结局指标

主要结局

Acute kidney injury

时间窗: At day 3 of PICU admission

Development of AKI by KDIGO Stage 2 criteria (Creatinine \> 200% baseline)

次要结局

  • PICU length of stay(60 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajit Basu, MD, F.A.A.P.

Director, Center for Acute Care Nephrology

Children's Hospital Medical Center, Cincinnati

研究点 (1)

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