NCT01573962已完成不适用
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
研究概览
简要总结
The objective of this sample collection study is to collect blood and urine samples. 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
- •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
- •At least one of the following acute conditions documented within 24 hours prior to enrollment
- •Respiratory SOFA score of ≥ 2 (PaO2/FiO2 <300)
- •Cardiovascular SOFA score of ≥ 1 (MAP < 70 mm Hg and/or any vasopressor required
- •Subject (or authorized representative) able and willing to provide written informed consent for study participation.
排除标准
- •Special populations including women with known pregnancy, prisoners or institutionalized individuals
- •Previous renal transplantation
- •Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3
- •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)
结局指标
主要结局
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury
时间窗: 04/1/2012 to 3/29/13
次要结局
未报告次要终点
研究者
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