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SepsisSEPP1BNCT02295514

Correlation Between PTP1B Expression and Organ Failure During Sepsis

A study testing PTP1B dosage in people with Sepsis, run by University Hospital, Rouen at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite major advances in the treatment and understanding of the pathophysiological mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a prevalence > 20% in intensive care units, it is now in a population increasingly aging with many co-morbidities, a real public health problem. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
PTP1B dosage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteFrance
Study dates
Jan 2015to May 2016
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

  • Patients in ICU for septic shock
  • Person belonging to a social security system
  • Informed patient who signed consent
  • Contraceptive method in women of reproductive age

Who cannot join

  • Pregnancy
  • Patient not able to take a decision because of an administrative or legal decision
  • Patient participating to an other interventional study
  • BMI > 30 kg/m2
  • Diabetes with specific treatment

Trial locations and contacts

1 site in 1 country.

France1 site

  • Rouen University Hospital

    Rouen

Other trials in France

About this study

Despite major advances in the treatment and understanding of the pathophysiological mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. With a prevalence > 20% in intensive care units, it is now in a population increasingly aging with many co-morbidities, a real public health problem. Thus, changes in treatment to physiological axes could change the prognosis of these patients. Protein Tyrosine Phosphatase 1B (PTP1B) is involved in the negative regulation of many cellular pathways such as the response to insulin, leptin and certain growth factors and endothelial nitric oxide production. PTP1B appears to be particularly involved in the control of endothelial function and insulin secretion. Under these conditions, encouraging results have been obtained in a model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by inhibition of PTP1B on models of heart failure. Recent advances have broadened the pathophysiological implications of PTP1B conferring a potential role in the regulation of inflammatory processes. In an experimental model of septic shock (Inserm 1096), the investigators demonstrated a significant improvement in survival and cardiovascular function in genetically deficient mice PTP1B (PTP1B - / -). Finally, PTP1B is involved in the downregulation of the signaling pathway of insulin via a feedback phenomenon. Septic shock induces many changes in carbohydrate metabolism. These changes result in hyperglycemia associated with insulin resistance, an independent risk factor of morbidity and mortality. Taken together, these data suggest that the expression of PTP1B could be useful in septic patients by modulating insulin resistance and thus the prognosis of these patients. This justifies the investigator clinical research project on the relationship between the expression of PTP1B levels, glycemic status and prognosis evaluated by the SOFA score in patients with septic shock with multiple organ failure.

Conditions
Sepsis
Being tested
PTP1B dosage
Keywords
Sepsis, Septic shock
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PTP1B dosageBiological

    PTP1B sampled and dosed during sepsis

Study groups in NCT02295514
Study groupRoleWhat they receive
PTP1B dosageExperimentalPTP1B dosage during sepsis
Receives: Biological: PTP1B dosage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in PTP1B level expression

    Change from baseline in PTP1B level expression by biological analysis

    Measured: Day 5

  2. Number of patients with organ failure

    Number of patients with organ failure

    Measured: Day 5

Secondary outcomes (7)

  1. Dose of insulin administered during the sepsis

    cumulative dose of insulin administered in the first 5 days of hospitalization

    Measured: Day 5

  2. Insulin resistance evaluation

    Evaluation of insulin resistance by biological analysis

    Measured: Day 1

  3. Blood glucose Analysis

    Analysis of the variability in Blood glucose

    Measured: Day 5

  4. Number of death participants at ICU discharge

    ICU mortality at day 28

    Measured: ICU discharge, day 28

  5. Number of death participants at at the end of the study

    Mortality at day 28

    Measured: Day 28

  6. Number of death participants at at hospital discharge

    Mortality at hospital discharge, average of 10 days after surgical intervention

    Measured: 10 days (average)

  7. Duration of mechanical ventilation

    Duration of mechanical ventilation from admission to discharge

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02295514
Sponsor's protocol ID
2014/087/HP
Acronym
SEPP1B
Status last verified
May 2016
First submitted
23 Oct 2014
Last updated
12 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Elchebly M, Payette P, Michaliszyn E, Cromlish W, Collins S, Loy AL, Normandin D, Cheng A, Himms-Hagen J, Chan CC, Ramachandran C, Gresser MJ, Tremblay ML, Kennedy BP. Increased insulin sensitivity and obesity resistance in mice lacking the protein tyrosine phosphatase-1B gene. Science. 1999 Mar 5;283(5407):1544-8. doi: 10.1126/science.283.5407.1544.

    PubMed 10066179

  • Coquerel D, Neviere R, Delile E, Mulder P, Marechal X, Montaigne D, Renet S, Remy-Jouet I, Gomez E, Henry JP, do Rego JC, Richard V, Tamion F. Gene deletion of protein tyrosine phosphatase 1B protects against sepsis-induced cardiovascular dysfunction and mortality. Arterioscler Thromb Vasc Biol. 2014 May;34(5):1032-44. doi: 10.1161/ATVBAHA.114.303450. Epub 2014 Feb 27.

    PubMed 24578383

  • Traves PG, Pardo V, Pimentel-Santillana M, Gonzalez-Rodriguez A, Mojena M, Rico D, Montenegro Y, Cales C, Martin-Sanz P, Valverde AM, Bosca L. Pivotal role of protein tyrosine phosphatase 1B (PTP1B) in the macrophage response to pro-inflammatory and anti-inflammatory challenge. Cell Death Dis. 2014 Mar 13;5(3):e1125. doi: 10.1038/cddis.2014.90.

    PubMed 24625984

  • Zabolotny JM, Kim YB, Welsh LA, Kershaw EE, Neel BG, Kahn BB. Protein-tyrosine phosphatase 1B expression is induced by inflammation in vivo. J Biol Chem. 2008 May 23;283(21):14230-41. doi: 10.1074/jbc.M800061200. Epub 2008 Feb 14.

    PubMed 18281274

  • Ali MI, Ketsawatsomkron P, Belin de Chantemele EJ, Mintz JD, Muta K, Salet C, Black SM, Tremblay ML, Fulton DJ, Marrero MB, Stepp DW. Deletion of protein tyrosine phosphatase 1b improves peripheral insulin resistance and vascular function in obese, leptin-resistant mice via reduced oxidant tone. Circ Res. 2009 Nov 6;105(10):1013-22. doi: 10.1161/CIRCRESAHA.109.206318. Epub 2009 Sep 24.

    PubMed 19797171

  • Feldhammer M, Uetani N, Miranda-Saavedra D, Tremblay ML. PTP1B: a simple enzyme for a complex world. Crit Rev Biochem Mol Biol. 2013 Sep-Oct;48(5):430-45. doi: 10.3109/10409238.2013.819830. Epub 2013 Jul 23.

    PubMed 23879520

Questions about this trial

What is this clinical trial studying?

A study testing PTP1B dosage in people with Sepsis, 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 4 inclusion and 5 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 12 May 2016. 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?

Change from baseline in PTP1B level expression (time frame: Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02295514, which also lists 6 linked publications.

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 12 May 2016.

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