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临床试验/NCT00929448
NCT00929448已完成不适用

The Predictive Value of Clinical and Immunological Factors in the Development of Pneumonia After Traumatic Brain Injury

Royal Alexandra Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP

研究概览

简要总结

The development of pneumonia and other infections is one of the most common complications of a traumatic brain injury (TBI). Prior studies have also found that patients suffering from TBI also develop immune dysfunction consistent with an immunosuppressed state shortly after the traumatic event. Specifically, it has been shown that patients with a TBI have impaired delayed type hypersensitivity (DTH), cellular immunity and humoral immunity. The humoral arm of the immune system is particularly involved in defending the host against extracellular bacteria and is primarily composed of B-cells, immunoglobulins and complement. Surgery and trauma impair the clonal expansion of antibody producing B lymphocytes causing hypogammaglobulinemia, through a mechanism involving T lymphocytes. In addition, during the systemic inflammatory process, pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-alpha), interleukin 1 (IL-1beta) and interleukin 6 (IL-6) are released. Nuclear factor kappa beta (NF-kB) is a transcriptional regulatory protein that is involved in the expression of proinflammatory cytokines and appears to act at a critical step in the transcription of many proinflammatory genes.

The hypothesis of this study is that the hypogammaglobulinemia from the immune dysfunction and the induction of NF-kB from the inflammatory process are, in part, responsible for the development of pneumonia and other infectious complications identified after TBI. This study has two specific aims: The primary specific aim of this study is to determine the association between serum immunoglobulin or NF-kB levels and the development of pneumonia in patients suffering from traumatic brain injury (TBI). The secondary specific aim of this study is to determine the relative contribution of clinical variables such as APACHE II-III Score and Injury Severity Score as compared to immunological variables (serum immunoglobulins and NF-kB) to the development of pneumonia in patients suffering from TBI.

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 yrs
  • Admitted to ICU in Capital Health region with a TBI and > 1 of the following:
  • An initial resuscitated (Sys BP>90 mmHg and O2 Sat >90%) GSC of ≤ 8
  • A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS at presentation to the hospital of ≤ 8 in the absence of sedation
  • A post resuscitation (Sys BP>90 mmHg and O2 Sat >90%) GCS within 72 hrs of hospital admission of ≤ 8 in the absence of sedation
  • Intracranial pressure monitoring
  • Decompressive craniectomy
  • Presence of subfalcine, uncal, or supratentorial herniation either clinically or radiologically

排除标准

  • Longer than 5 days since ictus of TBI

结局指标

主要结局

The primary outcome of this study will be the development of the composite of either early onset pneumonia (EOP) or ventilator associated pneumonia (VAP

时间窗: baseline, d4, d7, d10, d14

次要结局

  • Secondary outcomes will include ICU and hospital mortality and LOS, duration of mechanical ventilation, Glasgow Outcome Score (GOS) at hospital discharge and at 6-months, and 1-year.(hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Demetrios J. Kutsogiannis

MD, MHS, FRCPC

Royal Alexandra Hospital

研究点 (1)

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