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The role of the CD200-CD200R pathway in human sepsis-associated immunoparalysis (SIMPA study)

Conditions
blood poisoning
sepsis
10027665
10004018
Registration Number
NL-OMON48977
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
35
Inclusion Criteria

- newly diagnosed sepsis as defined in the protocol
- 18 years or older
- able to understand the study information and sign an informed consent (as an
alternative, the presence of a representative that is able to understand the
study information and sign an informed consent)
- willing and according to the investigator able to follow the study procedures

Exclusion Criteria

- immunosuppressive therapy before admission to the ICU and thus before blood
can
be drawn
- pregnancy
- lactation
- known active HIV, HBV or HCV infection
- continuous venovenous hemofiltration (CVVH)
- coagulation disorder
- mechanical ventilation at home
- inclusion in a clinical intervention trial in which the intervention may
reasonably interfere with the outcomes of this study
- admission for more than two weeks on the wards prior to IC admission

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- cytokine / inflammatory mediator (protein) concentrations (a.o. TNF-a, IL-1&beta;,<br /><br>IL-6, IL-12, IFN-&gamma;, IL-8, IL-10 and TFG-&beta;) after ex vivo stimulation (with and<br /><br>without a CD200 axis (ant)agonist)<br /><br>- mRNA cytokine / inflammatory mediator expression (a.o. TNF-a, IL-1&beta;, IL-6,<br /><br>IL-12, IFN-&gamma;, IL-8, IL-10 and TGF-&beta;) after ex vivo stimulation (with and<br /><br>without a CD200 axis (ant)agonist)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1)<br /><br>- cell surface expression of immune receptors as CD200R, CD200 by direct flow<br /><br>cytometry (protein level) (in sepsis patients VS healthy controls)<br /><br>- mRNA expression of immune receptors as CD200R, CD200 (in sepsis patients VS<br /><br>healthy controls)<br /><br>- to determine the causing or contributing factors that alter the expression<br /><br>(a.o. signalling pathways)<br /><br>- cytokine / inflammatory mediator (protein) blood concentrations (a.o. TNF-a,<br /><br>IL-1&beta;, IL-6, IL-12, IFN-&gamma;, IL-8, IL-10 and TFG-&beta;)<br /><br><br /><br><br /><br>2) correlation between CD200(R) expression and SOFA score, CD200R expression<br /><br>levels in survivors and non-survivors</p><br>
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