An interventional study of Blood sampling and Bioelectrical impedance vector analysis in Septic Shock, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Prevention
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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 · Procedure: Bioelectrical impedance vector analysis · Procedure: Muscular echography
* D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube * D4 zonulin
* D1 * D4
* D1 * D4
PTP1B analysis
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
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Time frame: Day 1
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Time frame: Day 4
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).
Time frame: 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).
Time frame: Day 4
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Time frame: Day 1
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Time frame: Day 4
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen