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

NCT ID: NCT03189355

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-09

Study Completion Date

2019-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

* D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
* D4 zonulin

Bioelectrical impedance vector analysis

Intervention Type PROCEDURE

* D1
* D4

Muscular echography

Intervention Type PROCEDURE

* D1
* D4

Interventions

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Blood sampling

* D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
* D4 zonulin

Intervention Type PROCEDURE

Bioelectrical impedance vector analysis

* D1
* D4

Intervention Type PROCEDURE

Muscular echography

* D1
* D4

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline LEMAITRE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline LEMAITRE, MD

Role: CONTACT

232886697 ext. +33

Cécile POURCHER

Role: CONTACT

232886697 ext. +33

Facility Contacts

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Caroline LEMAITRE, MD

Role: primary

Other Identifiers

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2016/108/HP

Identifier Type: -

Identifier Source: org_study_id

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