NCT04105699已完成不适用
A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic's abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abionic SA
- 入组人数
- 544
- 试验地点
- 5
- 主要终点
- Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
研究概览
简要总结
This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision and understanding of signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis.
- •Male or female, aged ≥ 18 years.
- •Admitted to ICU on the day of screening, with expectation that patient will require ICU management for a minimum of 24 hours.
排除标准
- •Expected to die within 24 hours no matter what therapy is given, from the time of screening.
- •Suffering on ICU admission or study entry from or known acute or chronic pancreatitis or pancreatic cancer).
- •Admitted to ICU due to elective cardiac surgery with an uncomplicated stay anticipated.
- •Patients having a valid Do Not Resuscitate order.
- •Previous ICU admission during this hospital stay
- •Confirmed COVID-19 as reason for ICU admission
结局指标
主要结局
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
时间窗: Day 1
Assess the clinical sensitivity and specificity of the abioSCOPE PSP assay obtained on day 1 of ICU stay to identify sepsis within 3 days, based on EIRC assessment of sepsis.
次要结局
未报告次要终点
研究者
研究点 (5)
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