VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioMérieux
- 入组人数
- 477
- 试验地点
- 2
- 主要终点
- Risk of developing persistent severe AKI
研究概览
简要总结
This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test
详细描述
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.
The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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;
- •Documented 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 need not be performed for enrollment in this study.)
- •Special populations, pregnant women, prisoners or institutionalized individuals;
结局指标
主要结局
Risk of developing persistent severe AKI
时间窗: Within 48 hours of ICU admittance
The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which 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
次要结局
未报告次要终点