Near Patient Molecular Testing in Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
研究概览
简要总结
The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.
详细描述
The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old on the date of ICU admission
- •Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:
- •Temperature > 38°C or < 36°C
- •Heart Rate > 90 beat/min
- •Tachypnea > 20/min or PaCO2 < 32 mmHg
- •WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)
- •Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
- •Study sample collection within 24 hours of ICU admission order
排除标准
- •Age less than 18 years old on the day of ICU admission
- •No order to admit to ICU
- •Not physically admitted to ICU
- •Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
- •Study sample collection > 24 hours from ICU admission order
- •No clinical cultures or serologic tests obtained when sepsis was suspected
- •Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
- •Transfer from another ICU where subject was admitted for ≥ 24 hours.
结局指标
主要结局
Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
时间窗: Time for enrollment, process samples, and collect data, an average of 1 year
Percentage of correctly identified patients with sepsis or non-infectious systemic inflammation using SeptiCyte RAPID compared to clinical assessments using routine clinical, laboratory, and other findings.
次要结局
- Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.(Time for enrollment, process samples, and collect data, an average of 1 year)