A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abionic SA
- 入组人数
- 296
- 试验地点
- 14
- 主要终点
- Assessment of the performance of serial PSP values measured using the AbioScope.
研究概览
简要总结
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.
This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients (age ≥ 18 years)
- •Requiring ICU management
- •At high risk of sepsis (septic patients are excluded)
- •Expected ICU stay for more than 4 days
- •Have provided written informed consent or consent is given by the patient's legally designated representative.
排除标准
- •Patient expected to die within 48 hours of admission to ICU
- •Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.
结局指标
主要结局
Assessment of the performance of serial PSP values measured using the AbioScope.
时间窗: Day 1 to Day 30, or until discharge from ICU
i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.
次要结局
未报告次要终点