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临床试验/NCT01612117
NCT01612117已完成不适用

Is Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) the "Renal Troponin" in Invasive Cardiology?

University of Freiburg1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2011年11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
244
试验地点
1
主要终点
to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN

研究概览

简要总结

Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.

This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

详细描述

Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All except patients with exclusion criteria

排除标准

  • dialysis-dependent chronic kidney disease
  • lack of written consent

结局指标

主要结局

to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN

时间窗: 4-6 hours after PCP

cf title

次要结局

  • to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter(4-6 hours after PCP)

研究者

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

Stéphane Cook, Prof

Ms

University of Freiburg

研究点 (1)

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