NCT02882568已完成不适用
Analysis of Immune Response In Bacterial Infection of Obese Subject
Versailles Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
研究概览
简要总结
Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between18 and 80 years
- •obesity: BMI > 30
- •presumed bacterial infection:
- •pneumonitis (documented or probably)
- •pyelonephritis / acute prostatitis
- •soft tissue / skin infection (except for bedsore)
- •cholecystitis / angiocholitis
- •meningitis
- •clostridium colitis
- •surgical site infection
- •signed consent
排除标准
- •patients with viral, parasitic or mycotic documented infection
- •patients with bacterial infection with treatment> 4 weeks (ex. endocarditis; osteo- articular infections)
- •patients with prior antibiotic treatment (< 14 days)
- •intensive care unit patients
- •patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded)
- •patients with systemic disease
- •Known diagnosis of human immunodeficiency infection (DICV, HIV...)
- •immunosuppression treatment during last month including corticotherapy
- •pregnancy
- •3 months follow up not possible
- •non signed consent
研究组 & 干预措施
investigational
Other
Blood test for Inflammatory and immunological analysis during acute sepsis phase and one month later
干预措施: blood analysis (Biological)
结局指标
主要结局
Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
时间窗: T 0 and at 1 month
Standard inflammatory markers; immunological markers (cytokines, leptine, lymphocyte phenotype)
次要结局
- Analysis of leptine polymorphism(1 month)
- Evaluation of sepsis; correlation with inflammatory and immunological parameters(T 0 and at 1 month)
研究者
Roderick Meckenstock
Dr
Versailles Hospital
研究点 (1)
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