跳至主要内容
临床试验/NCT05483088
NCT05483088
已完成
不适用

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

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

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

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.

结局指标

主要结局

Stability of CCL14 in urine samples

时间窗: Up to 24 hours

Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test

研究点 (1)

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