NCT03189355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2018

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

May 22, 2017

Last Update Submit

February 5, 2026

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Intestinal permeability

    Day 1

  • Intestinal permeability

    Day 4

  • Body composition

    Day 1

  • Body composition

    Day 4

Study Arms (1)

Patients With Septic Shock

EXPERIMENTAL

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 samplingProcedure: Bioelectrical impedance vector analysisProcedure: Muscular echography

Interventions

Blood samplingPROCEDURE

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

Patients With Septic Shock
Bioelectrical impedance vector analysisPROCEDURE

* D1 * D4

Patients With Septic Shock
Muscular echographyPROCEDURE

* D1 * D4

Patients With Septic Shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breastfeeding
  • Prisoners
  • Patient with pacemaker or defibrillator
  • patient participating to a clinical trial with the same primary outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Caroline LEMAITRE

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 16, 2017

Study Start

January 9, 2017

Primary Completion

October 14, 2018

Study Completion

October 14, 2018

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)