跳至主要内容
临床试验/NCT03262558
NCT03262558已完成不适用

Immunological and Bacteriological Approaches to the Development of Postoperative Mediastinitis With Staphylococcus Aureus

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
Variation of plasma IDO activity

研究概览

简要总结

Cardiac surgery with extracorporeal circulation (ECC) yields a deep immune system dysfunction that exposes patients to postoperative infectious complications. Among these, post-operative mediastinitis with Staphylococcus aureus (SA) generates significant morbidity and mortality. Two radically different approaches have been proposed in recent years to reduce the incidence of this complication. A first approach has attempted, without real success, to decrease postoperative immunosuppression. The second, more efficient, consisted of screening and preoperatively treating patients colonized with SA. However, although its incidence has decreased, postoperative mediastinitis remains a terrible nosocomial infection. The authors believe that a thorough analysis of the immunological changes induced by cardiac surgery will initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby decreasing the risk of nosocomial infections. In addition, a study of the interactions between the operated (host) and staphylococcus aureus (pathogenic) immune systems will provide a better understanding of the mechanisms that expose patients to this bacterium.

详细描述

In particular, changes induced by the ECC will be evaluated on:

  • Indoleamine 2,3-dioxygenase activity (IDO)
  • Apoptosis of lymphocytes and dendritic cells
  • Polymorphonuclear neutrophils (PMNs)
  • Myeloid Derived Suppressor Cells (MDSC )

After general anesthesia and arterial catheterization and prior to the start of ECC, blood samples will be taken for flow cytometry studies, for the purification of PMNs and monocytes. The purified PMNs and monocytes will then be used for the measurement of cytokine, phagocytosis and bactericidal production capacities.

The morning following surgery, blood samples will be taken and follow the same process.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Variation of plasma IDO activity

时间窗: Baseline and the morning following surgery

IDO activity is evaluated by the Kynurenin / Tryptophan ratio before and after ECC. Enzymatic activities will be measured by high performance liquid chromatography (HPLC) on pre- and post-operative blood tests

次要结局

  • Quantification of lymphocytic apoptosis before and after the ECC(Baseline and the morning following surgery)
  • Variation of bactericidal capacity of PMNs(Baseline and the morning following surgery)
  • Effect of an inhibitor of IDO on phagocytosis capacities of PMNs(The day following surgery)
  • Variation of phagocytosis capacity of PMNs(Baseline and the morning following surgery)
  • Variation of bactericidal capacity of macrophages(Baseline and the morning following surgery)
  • Effect of an inhibitor of IDO on phagocytosis capacities of macrophages(The day following surgery)
  • Effect of an inhibitor of IDO on bactericidal capacities of macrophages(The day following surgery)
  • Quantification of lymphocytic apoptosis in the presence of an inhibitor of IDO(The day following surgery)
  • Variation of phagocytosis capacity of macrophages(Baseline and the morning following surgery)
  • Effect of an inhibitor of IDO on bactericidal capacities of PMNs(The day following surgery)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Mediastinitis and Staphylococcus Aureus | 临床试验