NCT02052895已完成不适用
Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients
Mochida Pharmaceutical Company, Ltd.2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2014年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
研究概览
简要总结
This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).
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
- •Male or female aged ≥ 21 years
- •Appropriate clinical data to enable classification into sepsis or SIRS
- •Written informed consent by the patient or legally authorized representative
- •Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation
排除标准
- •No informed consent
- •Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
- •Inclusion Criteria:
- •Male or female aged ≥ 21 years
- •Does not meet clinical criteria for sepsis or SIRS
- •Written informed consent by the patient or legally authorized representative
- •Exclusion Criteria:
- •No informed consent
- •Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
- •End Stage Renal Disease
- •Inclusion Criteria:
- •Male or female aged ≥ 21 years
- •Documented diagnosis of end stage renal disease currently undergoing dialysis
- •Does not meet clinical criteria for sepsis or SIRS
- •Written informed consent by the patient or legally authorized representative
- •Exclusion Criteria:
- •No informed consent
- •Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit < 20%
结局指标
主要结局
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis
时间窗: Up to 7 days
For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.
次要结局
未报告次要终点
研究者
研究点 (2)
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