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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48977

Enrollment

Registered

2019-08-07

Start date

2019-09-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- cytokine / inflammatory mediator (protein) concentrations (a.o. TNF-a, IL-1β, IL-6, IL-12, IFN-γ, IL-8, IL-10 and TFG-β) after ex vivo stimulation (with and without a CD200 axis (ant)agonist) - mRNA cytokine / inflammatory mediator expression (a.o. TNF-a, IL-1β, IL-6, IL-12, IFN-γ, IL-8, IL-10 and TGF-β) after ex vivo stimulation (with and without a CD200 axis (ant)agonist)	—

Secondary

Measure	Time frame
1) - cell surface expression of immune receptors as CD200R, CD200 by direct flow cytometry (protein level) (in sepsis patients VS healthy controls) - mRNA expression of immune receptors as CD200R, CD200 (in sepsis patients VS healthy controls) - to determine the causing or contributing factors that alter the expression (a.o. signalling pathways) - cytokine / inflammatory mediator (protein) blood concentrations (a.o. TNF-a, IL-1β, IL-6, IL-12, IFN-γ, IL-8, IL-10 and TFG-β) 2) correlation between CD200(R) expression and SOFA score, CD200R expression levels in survivors and non-survivors	—

Measure

Time frame

1) - cell surface expression of immune receptors as CD200R, CD200 by direct flow cytometry (protein level) (in sepsis patients VS healthy controls) - mRNA expression of immune receptors as CD200R, CD200 (in sepsis patients VS healthy controls) - to determine the causing or contributing factors that alter the expression (a.o. signalling pathways) - cytokine / inflammatory mediator (protein) blood concentrations (a.o. TNF-a, IL-1β, IL-6, IL-12, IFN-γ, IL-8, IL-10 and TFG-β) 2) correlation between CD200(R) expression and SOFA score, CD200R expression levels in survivors and non-survivors

—

Countries

Netherlands

Outcome results