NCT05483088已完成不适用
Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Stability of CCL14 in urine samples
研究概览
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.
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
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
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Specimen Stability StudyAcute Kidney InjuryNCT01846884Astute Medical, Inc.124
招募中
不适用
SC2i Tissue and Data Repository ProtocolCritical IllnessNCT02182180Henry M. Jackson Foundation for the Advancement of Military Medicine5,000
已完成
不适用
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)Human Papilloma Virus InfectionNCT02714114Universiteit Antwerpen57
已完成
不适用
Standard Operating Procedures for Cervical (Pre)Cancer Biomarker Detection in First-void Urine (BM-SOP Study)Cervical CancerNCT02714127Universiteit Antwerpen128
已完成
不适用
Evaluation of Urine Samples and Their Relation to Urinary Tract InfectionUrinary Tract InfectionsNCT03522766Coloplast A/S30