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临床试验/NCT04635878
NCT04635878Unknown不适用

Study of INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit (INFLA-SEPSIS)

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution

研究概览

简要总结

septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens

详细描述

since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. One study focused on the role of the NLRP3 inflammasome in monocyte during sepsis has shown its early alteration that is correlated with mortality. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. The aim of the study is to analyze the activation of NLRP3 inflammasome in platelets and leukocytes during sepsis, from patients hospitalized in intensive care unit compare to a control group, until its resolution to better understand the pathophysiology of sepsis

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • hospitalized in intensive care unit with central catheter
  • age > or = 18 years
  • patients suffering from sepsis
  • hospitalized from less than72 hours

排除标准

  • patients with curatorship or guardianship
  • pregnant women
  • patients suffering from malignant blood disease
  • patients suffering from disease associated with NLRP3 inflammasome activation
  • CONTROL GROUP:
  • Inclusion Criteria:
  • hospitalized in intensive care unit with central catheter for other reason than infection
  • age > or = 18 years
  • Exclusion Criteria:
  • patients with infection disease
  • patients with curatorship or guardianship
  • pregnant women
  • patients suffering from malignant blood disease
  • patients suffering from disease associated with NLRP3 inflammasome activation

结局指标

主要结局

Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution

时间窗: From day 0 to the hospital discharge, an average of 1 month

Activation kinetics of the NLRP3 inflammasome from day 0 to patient discharge measured by the area under curve

次要结局

  • Severity score measured by Simplified Gravity Index 2(Day of hospital discharge, an average of 1 month)
  • Rate of inflammasome NLRP3 activation(Day of hospital discharge, an average of 1 month)
  • Severity score measured by Sequential Organ Failure Assessment (SOFA) score(Day of hospital discharge, an average of 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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