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临床试验/NCT02003196
NCT02003196已完成不适用

Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2014年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
1
主要终点
Ventilatory-free days at day 90

研究概览

简要总结

Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

详细描述

PCR for herpes simplex virus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results PCR for Cytomegalovirus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalisation in intensive care unit
  • Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow Coma Scale <= 12
  • Age between 18 and 75 years
  • Mechanical ventilation > 24 hours

排除标准

  • encephalopathy post anoxy
  • active cancer
  • Immunosuppresseur treatment
  • pregnancy
  • history of autoimmune disease

结局指标

主要结局

Ventilatory-free days at day 90

时间窗: 90 days

次要结局

  • Bacterial hospital acquiered infection(28 days)
  • organ failure(28 days)
  • hospitalisation length of stay(28 days)
  • Mortality(28 days and 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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