INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit

Study Overview
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Brief Summary
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septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens

Detailed Description
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since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. One study focused on the role of the NLRP3 inflammasome in monocyte during sepsis has shown its early alteration that is correlated with mortality. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets. The aim of the study is to analyze the activation of NLRP3 inflammasome in platelets and leukocytes during sepsis, from patients hospitalized in intensive care unit compare to a control group, until its resolution to better understand the pathophysiology of sepsis

Official Title
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Study of INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit (INFLA-SEPSIS)

Conditions
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Sepsis

Intervention / Treatment
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* Other: Blood collection


Participation Criteria
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Eligibility Criteria
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SEPSIS GROUP: Inclusion Criteria: hospitalized in intensive care unit with central catheter age > or = 18 years patients suffering from sepsis hospitalized from less than72 hours Exclusion Criteria: patients with curatorship or guardianship pregnant women patients suffering from malignant blood disease patients suffering from disease associated with NLRP3 inflammasome activation CONTROL GROUP: Inclusion Criteria: hospitalized in intensive care unit with central catheter for other reason than infection age > or = 18 years Exclusion Criteria: patients with infection disease patients with curatorship or guardianship pregnant women patients suffering from malignant blood disease patients suffering from disease associated with NLRP3 inflammasome activation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis group<br>patients suffering from sepsis hospitalized in intensive care unit | Other: Blood collection<br>* Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes<br>|
| Control group<br>patients without infection hospitalized in intensive care unit | Other: Blood collection<br>* Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution | Activation kinetics of the NLRP3 inflammasome from day 0 to patient discharge measured by the area under curve | From day 0 to the hospital discharge, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of inflammasome NLRP3 activation | Rate of inflammasome NLRP3 activation (measured in blood samples) | Day 0 | 
| Rate of inflammasome NLRP3 activation | Rate of inflammasome NLRP3 activation (measured in blood samples) | Day 2 | 
| Rate of inflammasome NLRP3 activation | Rate of inflammasome NLRP3 activation (measured in blood samples) | Day 7 | 
| Rate of inflammasome NLRP3 activation | Rate of inflammasome NLRP3 activation (measured in blood samples) | Day of hospital discharge, an average of 1 month | 
| Severity score measured by Sequential Organ Failure Assessment (SOFA) score | Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome | Day 0 | 
| Severity score measured by Sequential Organ Failure Assessment (SOFA) score | Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome | Day 2 | 
| Severity score measured by Sequential Organ Failure Assessment (SOFA) score | Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome | Day 7 | 
| Severity score measured by Sequential Organ Failure Assessment (SOFA) score | Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome | Day of hospital discharge, an average of 1 month | 
| Severity score measured by Simplified Gravity Index 2 | Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome | Day 0 | 
| Severity score measured by Simplified Gravity Index 2 | Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome | Day 2 | 
| Severity score measured by Simplified Gravity Index 2 | Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome | Day 7 | 
| Severity score measured by Simplified Gravity Index 2 | Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome | Day of hospital discharge, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NLRP3 inflammasome, platelets, cytokines, thrombus, septic shock, sepsis