Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Study of the variation of a marker of endoplasmic reticulum stress, between the pre- extracorporeal circulation (CEC) sample and the sample taken 2 hours after the release of extracorporeal circulation
研究概览
简要总结
The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans .
For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Major patient (age ≥ 18 years)
- •Patient undergoing cardiac surgery under extracorporeal circulation (duration of planned CEC > 1h)
- •Informed person, having read and signed his consent preoperatively no later than the day before the procedure.
- •Person affiliated with a social security scheme
- •Effective contraception in women of childbearing potential. For menopausal women, the diagnosis of menopause will be based on the gynecological history of the patient (age> 50 years + amenorrhea for more than 12 months).
排除标准
- •Patient with urgent cardiac surgery
- •Patient with cardiac surgery without extracorporeal circulation
- •Patient with surgery under "mini-CEC"
- •Patient with simple aortic valve replacement or single / double coronary artery bypass (CEC duration typically <1h)
- •Patient with chronic autoimmune inflammatory disease, eg lupus, rheumatoid arthritis, inflammatory bowel disease ...
- •Patient with progressive neoplastic disease
- •Patient with underlying heart disease with left ventricular ejection fraction <30%
- •Pregnant or lactating woman
- •Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)
- •Patient participating in another interventional clinical trial
研究组 & 干预措施
All patients
干预措施: Cardiac surgery (Procedure)
结局指标
主要结局
Study of the variation of a marker of endoplasmic reticulum stress, between the pre- extracorporeal circulation (CEC) sample and the sample taken 2 hours after the release of extracorporeal circulation
时间窗: 2 hours after the release of extracorporeal circulation
ELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).
次要结局
未报告次要终点