Correlation Between PTP1B Expression and Organ Failure During Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change from baseline in PTP1B level expression
研究概览
简要总结
Despite major advances in the treatment and understanding of the pathophysiological mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a prevalence > 20% in intensive care units, it is now in a population increasingly aging with many co-morbidities, a real public health problem. Thus, changes in treatment to physiological axes could change the prognosis of these patients. Protein Tyrosine Phosphatase 1B (PTP1B) is involved in the negative regulation of many cellular pathways such as the response to insulin, leptin and certain growth factors and endothelial nitric oxide production. PTP1B appears to be particularly involved in the control of endothelial function and insulin secretion. Under these conditions, encouraging results have been obtained in a model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by inhibition of PTP1B on models of heart failure. Recent advances have broadened the pathophysiological implications of PTP1B conferring a potential role in the regulation of inflammatory processes. In an experimental model of septic shock (Inserm 1096), the investigators demonstrated a significant improvement in survival and cardiovascular function in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock induces many changes in carbohydrate metabolism. These changes result in hyperglycemia associated with insulin resistance, an independent risk factor of morbidity and mortality. Taken together, these data suggest that the expression of PTP1B could be useful in septic patients by modulating insulin resistance and thus the prognosis of these patients. This justifies the investigator clinical research project on the relationship between the expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in patients with septic shock with multiple organ failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 for septic shock
- •Person belonging to a social security system
- •Informed patient who signed consent
- •Contraceptive method in women of reproductive age
排除标准
- •Pregnancy
- •Patient not able to take a decision because of an administrative or legal decision
- •Patient participating to an other interventional study
- •BMI > 30 kg/m2
- •Diabetes with specific treatment
结局指标
主要结局
Change from baseline in PTP1B level expression
时间窗: Day 5
Change from baseline in PTP1B level expression by biological analysis
Number of patients with organ failure
时间窗: Day 5
Number of patients with organ failure
次要结局
- Blood glucose Analysis(Day 5)
- Number of death participants at at the end of the study(Day 28)
- Number of death participants at at hospital discharge(10 days (average))
- Dose of insulin administered during the sepsis(Day 5)
- Insulin resistance evaluation(Day 1)
- Duration of mechanical ventilation(Day 28)
- Number of death participants at ICU discharge(ICU discharge, day 28)