VIDAS Nephroclear CCL14 : Sample Stability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioMérieux
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sample stability conditions
研究概览
简要总结
This VIDAS® NEPHROCLEAR™ CCL14 (VIDAS® NCL™ CCL14) Sample Stability clinical trial is a multicenter, prospective, and qualitative study. The main study objective is to determine sample stability conditions for the VIDAS® NEPHROCLEAR™ CCL14 Test. This test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
详细描述
Product name and intended use
The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI) as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment. The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.
Product description
The VIDAS® NEPHROCLEAR™ CCL14 Test is an automated assay for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of C-C motif chemokine ligand 14 (CCL14) protein in human urine using the Enzyme Linked Fluorescent Assay (ELFA) technique.
Trial Design Overview
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 21 years of age or older;
- •Receiving care in an intensive care unit;
- •Expected to remain in the ICU for at least 48 hours after enrollment;
- •Use of indwelling urinary catheter as standard care at the time of enrollment;
- •Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
- •Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
- •Written informed consent provided by patient or legally authorized representative (LAR).
排除标准
- •Prior kidney transplantation;
- •Comfort-measures-only status;
- •Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
- •Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing will not be performed for enrollment in this study.)
- •Special populations, pregnant women, prisoners or institutionalized individuals;
结局指标
主要结局
Sample stability conditions
时间窗: one sample will be collected per participant, aliquots will be tested at various conditions: fresh, after one to two freeze-thaw cycles, after refrigeration for 24 hours and after 6 hours at room temperature
Detection of CCL14 levels in urine, spanning the measuring range of the assay for several sample conditions.
次要结局
未报告次要终点