Septic ShockCoc-SEPP1BNCT03189355
Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock
A study testing Blood sampling, Bioelectrical impedance vector analysis and Muscular echography in people with Septic Shock, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Blood sampling, Bioelectrical impedance vector analysis and Muscular echography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2017to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding
- Prisoners
- Patient with pacemaker or defibrillator
- patient participating to a clinical trial with the same primary outcome
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Septic Shock
- Being tested
- Blood sampling, Bioelectrical impedance vector analysis, Muscular echography
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
- D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
- D4 zonulin
Bioelectrical impedance vector analysisProcedure or surgery
- D1
- D4
Muscular echographyProcedure or surgery
- D1
- D4
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Blood sampling; Procedure: Bioelectrical impedance vector analysis; Procedure: Muscular echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTP1B analysis
1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.
Measured: Day 1
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Measured: Day 1
Muscular composition
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Measured: Day 4
Secondary outcomes (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).
Measured: 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).
Measured: Day 4
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Measured: Day 1
Body composition
Body composition will be measured by impedancemetry on D1 and D4
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start9 Jan 2017
- Primary completion14 Oct 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline LEMAITRE, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189355
- Sponsor's protocol ID
- 2016/108/HP
- Acronym
- Coc-SEPP1B
- Status last verified
- Feb 2026
- First submitted
- 22 May 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT03189355
- Acronym / sponsor ID
- Coc-SEPP1B / 2016/108/HP
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 14 Oct 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Septic Shock | Experimental | Procedure: Blood sampling, Procedure: Bioelectrical impedance vector analysis, Procedure: Muscular echographyBlood sampling on D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube and D4 zonulin Bioelectrical impedance vector analysis on D1 + D4 Muscular echography on D1 + D4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Prisoners
- Patient with pacemaker or defibrillator
- patient participating to a clinical trial with the same primary outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling* D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube * D4 zonulin | Procedure or surgery | Patients With Septic Shock |
| Bioelectrical impedance vector analysis* D1 * D4 | Procedure or surgery | Patients With Septic Shock |
| Muscular echography* D1 * D4 | Procedure or surgery | Patients With Septic Shock |
Primary outcome
PTP1B analysis
Time frame: Day 1
1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.
Muscular composition
Time frame: Day 1
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
Muscular composition
Time frame: Day 4
Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T
4 secondary outcomes
Intestinal permeability
Time frame: Day 1
Intestinal permeability
Time frame: Day 4
Body composition
Time frame: Day 1
Body composition
Time frame: Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline LEMAITRE principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Bioelectrical impedance vector analysis and Muscular echography in people with Septic Shock, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTP1B analysis (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.