NCT01868724已完成不适用
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 主要终点
- Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
研究概览
简要总结
This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).
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 the first sample collection
- •First 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
- •History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
- •Special populations, pregnant women, prisoners or institutionalized individuals
- •Patient meets any of the following:
- •Active bleeding with an anticipated need for > 4 units PRBC in a day
- •Hemoglobin < 7 g/dL
- •Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes
结局指标
主要结局
Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine.
时间窗: Day 1-7 of enrollment
This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days.
次要结局
- None at this time(10 months)
研究者
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