NCT01846884已完成不适用
Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
研究概览
简要总结
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.
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
- •Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
- •Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
- •Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
- •Expected to remain in the ICU for at least 48 hours after enrollment
- •Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
- •Subject (or authorized representative)able and willing to provide written informed consent for study participation
排除标准
- •Special populations including children, pregnant women, and prisoners
- •Previous renal transplantation
- •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)
- •Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
- •Previously provided a urine sample and enrolled in this study
结局指标
主要结局
Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes.
时间窗: 6 months
次要结局
未报告次要终点
研究者
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