NCT06652100进行中（未招募）不适用
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)
BioPorto Diagnostics12 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年10月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 12
- 主要终点
- Cut off Establishment
研究概览
简要总结
The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.
- •Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU:
- •Vasoactive medication administration
- •Mechanical ventilation
- •Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula
- •Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only)
- •Serum Lactate greater than 2.5 mmol/L
- •History of solid organ transplantation, renal transplantation included only if more than 3 months prior
- •History of bone marrow transplantation Subject with signed informed consent.
排除标准
- •Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.
- •Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.
- •Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.
- •Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist.
- •Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU.
- •Subjects that have had surgical nephrectomy less than 3 months prior to admission.
- •Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available.
- •Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission
结局指标
主要结局
Cut off Establishment
时间窗: 24hrs after ICU admission
The primary objective is to establish the cut-off value for the ProNephro AKI (NGAL) in critically ill adult patients (age 22 and older) admitted to ICU when used as an aid in risk assessment of the development of moderate to severe acute kidney injury (KDIGO stage 2/3) within 48-72 hrs. after admission.
次要结局
- Sub-Group analysis(24hrs after ICU admission)
研究者
研究点 (12)
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