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临床试验/NCT01135277
NCT01135277已完成不适用

Immune Suppression and Ventilator Associated Pneumonias

Matthew Exline1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2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
50
试验地点
1
主要终点
Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.

研究概览

简要总结

Patients in the ICU are already predisposed to nosocomial infections, which are both costly and potentially life threatening, and it appears that the immune paralysis of sepsis may put these patients at greater risk for secondary infections, though this has not been proven conclusively. One measure of this sepsis-induced immune suppression is monocyte deactivation. The investigators hypothesize that, as a cornerstone of the monocytic innate immune response to infection, the inflammasome is critical to monocyte function during sepsis.

详细描述

Sepsis is a systemic inflammatory response to a severe infection. Despite the high incidence and societal costs of sepsis, the mechanism by which it kills remains unclear. The pathophysiology of sepsis is not completely understood, but many investigators now believe that sepsis induces a prolonged state of immune suppression. This study will attempt to quantify the degree of immune suppression during the first 5 days of sepsis by measuring the immune function of peripheral blood monocytes and the inflammasome constituent proteins in peripheral blood monocytes and alveolar macrophages.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years.
  • Have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome [SIRS] signs [tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia]) and a known or suspected infection for SEPTIC arm.
  • Patients without criteria for sepsis will be eligible for CONTROL arm. Patient must consent to have blood drawn within 24 hours of initiation of mechanical ventilation (for CONTROL arm) and 24 hours of new episode of sepsis to be eligible (for SEPTIC arm).

排除标准

  • Consent not available or declined
  • Died before blood collected
  • Onset of sepsis more than 24 hours prior to transfer to OSUMC,mechanical ventilation greater than 24 hours
  • Anticipation of less than 24 hours of mechanical ventilation by primary team
  • Women who are pregnant.

结局指标

主要结局

Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.

时间窗: Day 5

Blood and BAL fluid will be collected at Day 5

次要结局

未报告次要终点

研究者

发起方
Matthew Exline
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew Exline

Assistant Professor Clinical

Ohio State University

研究点 (1)

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