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临床试验/NCT02965339
NCT02965339Unknown不适用

Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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