Correlation Between PTP1B Expression and Organ Failure During Sepsis (SEPP1B)

May 10, 2016 updated by: University Hospital, Rouen
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTP1B dosage
PTP1B dosage during sepsis
Biological: PTP1B dosage
PTP1B sampled and dosed during sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in PTP1B level expression
Time Frame: Day 5
Change from baseline in PTP1B level expression by biological analysis
Day 5
Number of patients with organ failure
Time Frame: Day 5
Number of patients with organ failure
Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of insulin administered during the sepsis
Time Frame: Day 5
cumulative dose of insulin administered in the first 5 days of hospitalization
Day 5
Insulin resistance evaluation
Time Frame: Day 1
Evaluation of insulin resistance by biological analysis
Day 1
Blood glucose Analysis
Time Frame: Day 5
Analysis of the variability in Blood glucose
Day 5
Number of death participants at ICU discharge
Time Frame: ICU discharge, day 28
ICU mortality at day 28
ICU discharge, day 28
Number of death participants at at the end of the study
Time Frame: Day 28
Mortality at day 28
Day 28
Number of death participants at at hospital discharge
Time Frame: 10 days (average)
Mortality at hospital discharge, average of 10 days after surgical intervention
10 days (average)
Duration of mechanical ventilation
Time Frame: Day 28
Duration of mechanical ventilation from admission to discharge
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: steven grangé, MD, Rouen Universitary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/087/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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