Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock (Coc-SEPP1B)
Primary Purpose
Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Bioelectrical impedance vector analysis
Muscular echography
Sponsored by
About this trial
This is an interventional prevention trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy or breastfeeding
- Prisoners
- Patient with pacemaker or defibrillator
- patient participating to a clinical trial with the same primary outcome
Sites / Locations
- Rouen University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients With Septic Shock
Arm Description
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
Outcomes
Primary Outcome Measures
PTP1B analysis
1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Secondary Outcome Measures
Intestinal permeability
1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).
Intestinal permeability
1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189355
Brief Title
Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock
Acronym
Coc-SEPP1B
Official Title
Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2017 (Actual)
Primary Completion Date
January 9, 2019 (Anticipated)
Study Completion Date
February 9, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients With Septic Shock
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
D4 zonulin
Intervention Type
Procedure
Intervention Name(s)
Bioelectrical impedance vector analysis
Intervention Description
D1
D4
Intervention Type
Procedure
Intervention Name(s)
Muscular echography
Intervention Description
D1
D4
Primary Outcome Measure Information:
Title
PTP1B analysis
Description
1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.
Time Frame
Day 1
Title
Muscular composition
Description
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Time Frame
Day 1
Title
Muscular composition
Description
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Intestinal permeability
Description
1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).
Time Frame
Day 1
Title
Intestinal permeability
Description
1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).
Time Frame
Day 4
Title
Body composition
Description
Body composition will be measured by impedancemetry on D1 and D4
Time Frame
Day 1
Title
Body composition
Description
Body composition will be measured by impedancemetry on D1 and D4
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pregnancy or breastfeeding
Prisoners
Patient with pacemaker or defibrillator
patient participating to a clinical trial with the same primary outcome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline LEMAITRE, MD
Phone
232886697
Ext
+33
Email
Caroline.Lemaitre@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile POURCHER
Phone
232886697
Ext
+33
Email
cecile.pourcher@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline LEMAITRE
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline LEMAITRE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock
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