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临床试验/NCT03189355
NCT03189355已完成不适用

Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
PTP1B analysis

研究概览

简要总结

With a prevalence of more than 15% in ICU, septic shock today represents a real public health problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by an alteration of the body composition and in particular by a loss of muscle mass. In intensive care, there are indirect elements suggesting a link between loss of muscle mass and prognosis.

Muscle mass results from a balance between the pathway of proteolysis and that of protein synthesis, depending on many factors, not one of the most important are insulin. The protein PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates, constitutes an endogenous regulator of numerous intracellular signaling pathways, including that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed during sepsis leading clinically to impaired body composition including muscle body mass. Therefore, we propose to study the association between PTP1B and loss of muscle mass in patients in sepsis in resuscitation.

The intestinal barrier plays an essential role in protecting against microbial luminal flora and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of tight junctions, important actors in the intestinal barrier function. The increase in plasma zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal permeability (16). However, elevation of plasma zonulin has never been evaluated in septic resuscitation patients. This is why we propose the evaluation of the association between plasma zonulin and the loss of muscle mass in these resuscitation patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Septic shock or severe sepsis
  • Age > 18 years old
  • Affiliation to a social security system
  • Information and consent. If patient cannot give his consent, an emergency consent will be sign by trusted person
  • Contraception for woman, of childbearing age

排除标准

  • Pregnancy or breastfeeding
  • Prisoners
  • Patient with pacemaker or defibrillator
  • patient participating to a clinical trial with the same primary outcome

研究组 & 干预措施

Patients With Septic Shock

Experimental

Blood sampling on D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube and D4 zonulin Bioelectrical impedance vector analysis on D1 + D4 Muscular echography on D1 + D4

干预措施: Blood sampling (Procedure)

Patients With Septic Shock

Experimental

Blood sampling on D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube and D4 zonulin Bioelectrical impedance vector analysis on D1 + D4 Muscular echography on D1 + D4

干预措施: Bioelectrical impedance vector analysis (Procedure)

Patients With Septic Shock

Experimental

Blood sampling on D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube and D4 zonulin Bioelectrical impedance vector analysis on D1 + D4 Muscular echography on D1 + D4

干预措施: Muscular echography (Procedure)

结局指标

主要结局

PTP1B analysis

时间窗: Day 1

1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.

Muscular composition

时间窗: Day 4

Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T

Muscular composition

时间窗: Day 1

Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T

次要结局

  • Body composition(Day 4)
  • Intestinal permeability(Day 4)
  • Intestinal permeability(Day 1)
  • Body composition(Day 1)

研究者

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

研究点 (1)

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