An interventional study of PTP1B dosage in Sepsis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by University Hospital, Rouen · Not applicable and Interventional
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 54 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PTP1B dosage during sepsis
Biological: PTP1B dosage
PTP1B sampled and dosed during sepsis
Change from baseline in PTP1B level expression
Change from baseline in PTP1B level expression by biological analysis
Time frame: Day 5
Number of patients with organ failure
Number of patients with organ failure
Time frame: Day 5
Dose of insulin administered during the sepsis
cumulative dose of insulin administered in the first 5 days of hospitalization
Time frame: Day 5
Insulin resistance evaluation
Evaluation of insulin resistance by biological analysis
Time frame: Day 1
Blood glucose Analysis
Analysis of the variability in Blood glucose
Time frame: Day 5
Number of death participants at ICU discharge
ICU mortality at day 28
Time frame: ICU discharge, day 28
Number of death participants at at the end of the study
Mortality at day 28
Time frame: Day 28
Number of death participants at at hospital discharge
Mortality at hospital discharge, average of 10 days after surgical intervention
Time frame: 10 days (average)
Duration of mechanical ventilation
Duration of mechanical ventilation from admission to discharge
Time frame: Day 28
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Rouen