NCT04785391Unknown不适用
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
研究概览
简要总结
The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.
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);
- •Special populations, pregnant women, prisoners or institutionalized individuals.
结局指标
主要结局
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
时间窗: Within 5 days
次要结局
未报告次要终点
研究者
研究点 (1)
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