跳至主要内容
临床试验/NCT00786708
NCT00786708已完成不适用

Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population

Columbia University3 个研究点 分布在 2 个国家目标入组 2,304 人开始时间: 2006年12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
2,304
试验地点
3
主要终点
The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.

研究概览

简要总结

Hypothesis: In patients that present to an urban emergency room, a single urine neutrophil gelatinase-associated lipocalin (NGAL) measurement can classify their kidney disease as stable chronic kidney disease, acute tubular necrosis, urinary outlet obstruction or pre-renal azotemia.

详细描述

The purpose of this study is to determine whether urinary NGAL levels are able to distinguish the classical categories of renal disease. Previous studies have strongly suggested that this protein marks those with fulminant renal dysfunction with greater sensitivity and time resolution than currently used markers. Studies to date have been in highly selected populations: children and adults following cardiac surgery, infants with cardiovascular anomalies, and patients with known chronic kidney disease. Demonstration of similarly robust sensitivity and specificity in a broad Emergency Room population would strengthen the conception of NGAL as a marker of early or advancing kidney dysfunction. Most importantly, if NGAL can distinguish between types of renal disease at presentation in the ER, it might have important implications regarding ER management of these common presentations. For example, it could reduce diagnostic ambiguity and lag time from hours or days to seconds.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A. Must be greater than or equal to 18 years of age
  • B. Must satisfy the following age and sex stratified serum creatinine levels:
  • men between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
  • women between ages 18 and 50 with serum creatinine greater than 1.2mg/dl
  • men older than 50 with serum creatinine greater than 1.0mg/dl
  • women older than 50 with serum creatinine greater than 0.8mg/dl
  • C. All pts greater than or equal to 18 years of age without kidney failure defined by B

排除标准

  • 未提供

结局指标

主要结局

The correlation of elevated urine NGAL with the diagnosis of intrinsic acute kidney injury.

时间窗: Assessed retrospectively after patient is discharged

次要结局

  • The correlation of urine NGAL and inpatient morbidity assessed by nephrology consultation and other factors such as dialysis initiation and intensive care unit stay.(Assessed retrospectively after patient is discharged)

研究者

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

Thomas Nickolas

Assistant Professor of Medicine, Department of Medicine, Nephrology

Columbia University

研究点 (3)

Loading locations...

相似试验