Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary endpoint was the occurrence of vasoplegic syndrome
研究概览
简要总结
Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...).
It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years.
- •Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
- •Consent signed.
排除标准
- •Standing arrhythmia.
- •Pregnant woman.
- •curative anticoagulation (warfarin, NANCO, heparin).
- •Patient under guardianship.
- •Patient Refused to participate.
- •Cardiac surgery without CPB.
- •bicuspid aortic valve.
- •Participation in another study.
- •preoperative sepsis.
- •Minor or major, under guardianship or trusteeship (art L1121-5, L1121-8 and L1122 1-2)
结局指标
主要结局
The primary endpoint was the occurrence of vasoplegic syndrome
时间窗: 6 months
The primary endpoint was the occurrence of vasoplegic syndrome correlate with markers of endothelial function following: IL8, P-selectin, von Willebrand factor precursor.
次要结局
- Markers of blood coagulation(6 months)
- Death(6 months)
- Complications(6 months)
- Occurrence of vasoplegic syndrome(6 months)
- Marker of degradation glycocalyx:(6 months)
- Inflammatory markers:(6 months)
