Correlation Between PTP1B Expression and Organ Failure During Sepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change from baseline in PTP1B level expression
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change from baseline in PTP1B level expression
Time Frame: Day 5
Change from baseline in PTP1B level expression by biological analysis
Number of patients with organ failure
Time Frame: Day 5
Number of patients with organ failure
Secondary Outcomes
- 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)