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临床试验/NCT06181604
NCT06181604已完成不适用

Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study

Bluejay Diagnostics, Inc.7 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2024年1月12日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
7
主要终点
28-day all-cause mortality
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
22 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (≥22 years of age)
  • •Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
  • •Admitted or intended to be admitted to the ICU
  • •At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock.

排除标准

  • •Prisoners or imprisonment at time of enrollment
  • •Prior enrollment into this study
  • •Informed consent as approved by IRB is unable to be obtained.

结局指标

主要结局

28-day all-cause mortality

时间窗: Within 28 days after inclusion

Participants will be followed up for 28 days for all-cause mortality

次要结局

  • In-hospital mortality up to 28 days(Within 28 days after inclusion)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

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