The Effect of Vagus Nerve Stimulation on the Inflammatory Response After Lung Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations
研究概览
简要总结
Systemic inflammation is a potentially debilitating complication of thoracic surgeries that can result in significant physical and economic morbidity for afflicted patients. There is compelling evidence for the role of central nervous system in the regulation of systemic inflammatory responses through humoral mechanisms. Activation of afferent vagus nerve fibers by cytokines triggers anti-inflammatory responses. Direct electrical stimulation of the peripheral vagus nerve in vivo during lethal endotoxemia in rats inhibited Tumor necrosis factor (TNF) synthesis in liver preventing the development of shock. The vagal regulatory role of systemic inflammation after lung lobectomy is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lung Lobectomy or pneumonectomy
- •Open surgery
排除标准
- •Current infection
结局指标
主要结局
The postsurgical inflammatory response: the effect of vagus stimulation on proinflammatory interleukin concentrations
时间窗: 3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day
changes of serum Interleukin (IL-6, IL-10, IL-18, IL-1) concentrations in pg/ml from baseline and over the postsurgical course up to the 4th postoperative day in both study groups. The baseline is defined as the serum concentration of the target interleukins at 24 hours prior to surgery. Afterwards the changes in the interleukins concentrations will be measured on the 1st and 4th postoperative days in both groups in order to analyze the effect of vagus stimulation on the intensity of the postsurgical inflammatory response.
次要结局
- The effect of vagus stimulation on changes in Serum C reactive protein (CRP) concentrations(3 time points: 24 hour prior to Operation (baseline), 1st and 4th postoperative day)
研究者
Mohamed Salama
MD, PhD
Otto Wagner Hospital