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

U

University Hospital, Rouen

Status

Completed

Conditions

Septic Shock

Treatments

Procedure: Muscular echography
Procedure: Blood sampling
Procedure: Bioelectrical impedance vector analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT03189355
2016/108/HP

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

Patients With Septic Shock
Experimental group
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
Treatment:
Procedure: Bioelectrical impedance vector analysis
Procedure: Blood sampling
Procedure: Muscular echography

Trial contacts and locations

1

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Central trial contact

Cécile POURCHER; Caroline LEMAITRE, MD

Data sourced from clinicaltrials.gov

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