Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock (Coc-SEPP1B)

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: Blood sampling; Procedure: Bioelectrical impedance vector analysis; Procedure: Muscular echography

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline LEMAITRE, MD; Phone Number: +33 232886697; Email: Caroline.Lemaitre@chu-rouen.fr
• Study Contact Backup: Name: Cécile POURCHER; Phone Number: +33 232886697; Email: cecile.pourcher@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • ROUEN university hospital
    • Contact: Caroline LEMAITRE, MD

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients With Septic Shock; 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	Procedure: Blood sampling; D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube; D4 zonulin; Procedure: Bioelectrical impedance vector analysis; D1; D4; Procedure: Muscular echography; D1; D4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTP1B analysis	1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.	Day 1
Muscular composition	Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T	Day 1
Muscular composition	Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1
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).	Day 4
Body composition	Body composition will be measured by impedancemetry on D1 and D4	Day 1
Body composition	Body composition will be measured by impedancemetry on D1 and D4	Day 4

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Caroline LEMAITRE, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Anticipated): January 9, 2019
• Study Completion (Anticipated): February 9, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2016/108/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No