Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Identify prognostic markers for the progression of sepsis to septic shock
研究概览
简要总结
Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.
The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients,
- •Patients between 45 and 75 years of age,
- •Patients undergoing major esophageal or digestive carcinological surgery,
- •Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).
排除标准
- •patients under 45 and aged 76 and over,
- •female patients,
- •non-carcinological or minor surgery,
- •non-esophageal or non-digestive surgery,
- •Gram-positive bacterial or fungal infections in the absence of associated BGN,
- •patients with hematological cancer,
- •immunocompromised patients,
- •septic surgery (surgical site infection),
- •patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study,
- •patients under guardianship or curatorship,
- •patients not affiliated to a social security system or equivalent in France,
- •patients deprived of their liberty.
研究组 & 干预措施
Septic shock
Patients with sepsis admitted to intensive care who developed septic shock.
干预措施: blood sampling (Other)
No septic shock
Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)
干预措施: blood sampling (Other)
结局指标
主要结局
Identify prognostic markers for the progression of sepsis to septic shock
时间窗: 18 months
Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.
次要结局
- Epigenetic marks and associated candidate genes identified in PBMC(18 months)
- Epigenetic markers comparaison(18 months)
- Differentials in epigenetic marks and associated candidate genes(18 months)