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临床试验/NCT04423523
NCT04423523已完成不适用

Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.

研究概览

简要总结

The investigators have previously reported that cardiac surgery with cardiopulmonary bypass (CPB) in young infants induced a drastic reduction in mHLA-DR (Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequently induce an immune-suppressed state. We hypothesize that analyzing the proteomic and the whole blood transcriptomic response after cardiac surgery would provide new insights into the pathophysiological mechanisms of CPB-related inflammatory response.

详细描述

Plasma levels of heat shock protein and inflammatory-related proteins will be measured at four time points (prior to the onset of surgery, Hour 6 postoperative, day 1 and day 3 after surgery). Whole blood transcriptomic analysis will be performed before and after surgery. The immune suppression induced by CPB will be assessed by in vitro experiments.

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
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patient admitted to pediatric intensive care at Nantes University Hospital after cardiac surgery
  • Age ≤ 3 months corrected age.
  • Control group: patients less than 3 months old following cardiac surgery without CPB or digestive surgery with a central venous catheter.

排除标准

  • Futility of care with cessation of blood tests as part of a limitation of active therapies;
  • Absence of parents for information
  • Refusal of parents after information (Lack of parental consent)
  • Blood volume collected for medical purposes incompatible with the needs of the research.

结局指标

主要结局

Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.

时间窗: prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery

Change of plasma levels of DAMPs after cardiopulmonary bypass Plasma levels of heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9 and IL-33 before and after CBP.

Plasma levels of inflammation-related proteins, including some DAMPs, heat shock protein (HSP 70), high mobility group box (HMGB1), S100A9, IL-33 before and after surgery.

时间窗: prior to the onset of CPB, 6 hours, day 1 and day 3 after surgery

Change of plasma levels of inflammation-related proteins before and after surgery.

次要结局

  • Effect of DAMPs on immune function:In vitro change of HLA-DR expression.(6 hours after surgery)
  • Effect of DAMPs on immune function:Secretion of IL-10 ( Interleukine 10).(6 hours after surgery)
  • Whole blood transcriptome before and after surgery.(Prior to the onset of surgery and 6 hours after surgery)
  • Characterization of CPB-immune dysfunction in vitro(Prior to the onset of surgery and 6 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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