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临床试验/NCT03881566
NCT03881566已完成不适用

Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients

Jongmin Lee1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
119
试验地点
1
主要终点
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients.

研究概览

简要总结

This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise 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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged ≥ 19 years
  • Appropriate clinical data to enable classification into sepsis
  • Written informed consent by the patient or legally authorized representative
  • Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation

排除标准

  • No informed consent
  • A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

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 immunocompetent and immunocompromised patients.

时间窗: up to 7 days

For the analysis, plasma presepsin levels on Day 0 will be used. Sepsis was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between immunocompromised and immunocompetent patients is compared to that of procalcitonin.

次要结局

  • survival at ICU discharge or day 28 after enrollment(28 days)

研究者

发起方
Jongmin Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jongmin Lee

Professor

Seoul St. Mary's Hospital

研究点 (1)

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