Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)
研究概览
简要总结
Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.
详细描述
NB : A repartition according to other ongoing study (HYPOECMO NCTNCT02754193) is planned
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients in ICU
- •Refractory cardiogenic shock
- •Cardiogenic shock: Systolic Arterial Pressure <90mmHg, or Mean Arterial Pressure <65mmHg, adequate volemia, peripheral hypoperfusion symptoms, cardiac index < 2.2 l/min/m2)
- •Refractory state: hypo responsiveness to norepinephrine AND/OR persisting profound hypo perfusion clinical symptoms despite optimal resuscitation
- •needing an Extra-Corporeal-Life-Support
- •informed consent from relatives or patient
- •Affiliation to a social security regimen
- •Preliminary medical examination
排除标准
- •Patients under ECLS for a/an :
- •Cardiotoxic poisoning
- •Human immunodeficient Virus or Viral hepatitis C
- •Patient < 18 yo
- •Pregnancy
- •Patient under protective supervision
结局指标
主要结局
Change in Cytokines (plasma TNF α, INF γ, IL4, IL 12, IL1 IL 6 IL 10)
时间窗: day 0 (ECLS initiation), day 3, day "ECLS weaning"
Exposition variable will be the density of α1, α2, β1, β2, β3-adrenoreceptors on immune cells (monocytes and lymphocytes T helper)
次要结局
- Cardiac output variation during a weaning ECLS procedure(day 3, day "ECLS weaning")
- Mortality(28 days and 90 days)
- Change in TH1 and TH2 pattern(day 0 (ECLS initation), day 3, day "ECLS weaning")
- Change in hemodynamic parameters(day 0 (ECLS initiation), day 3, day "ECLS weaning")
研究者
Dr Antoine KIMMOUN
PU-PH
Central Hospital, Nancy, France