Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects

Astute Medical, Inc.1 个研究点分布在 1 个国家目标入组 110 人2021年11月12日

适应症Acute Kidney Injury

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Acute Kidney Injury
发起方: Astute Medical, Inc.
入组人数: 110
试验地点: 1
主要终点: Stability of CCL14 in urine samples
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.

注册库

clinicaltrials.gov

开始日期

2021年11月12日

结束日期

2023年7月31日

最后更新

2年前

研究类型

Observational

性别

All

研究者

发起方

Astute Medical, Inc.

责任方

Sponsor

入排标准

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.