INFLA-SEPSIS: INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit
Study Details
Study Description
Brief Summary
septic shock is the first cause of mortality in intensive care unit. Innate immunity is the body's first line of defense against pathogens
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sepsis group patients suffering from sepsis hospitalized in intensive care unit |
Other: Blood collection
Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes
|
| Control group patients without infection hospitalized in intensive care unit |
Other: Blood collection
Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes
|
Outcome Measures
Primary Outcome Measures
- Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution [From day 0 to the hospital discharge, an average of 1 month]
Activation kinetics of the NLRP3 inflammasome from day 0 to patient discharge measured by the area under curve
Secondary Outcome Measures
- Rate of inflammasome NLRP3 activation [Day 0]
Rate of inflammasome NLRP3 activation (measured in blood samples)
- Rate of inflammasome NLRP3 activation [Day 2]
Rate of inflammasome NLRP3 activation (measured in blood samples)
- Rate of inflammasome NLRP3 activation [Day 7]
Rate of inflammasome NLRP3 activation (measured in blood samples)
- Rate of inflammasome NLRP3 activation [Day of hospital discharge, an average of 1 month]
Rate of inflammasome NLRP3 activation (measured in blood samples)
- Severity score measured by Sequential Organ Failure Assessment (SOFA) score [Day 0]
Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome
- Severity score measured by Sequential Organ Failure Assessment (SOFA) score [Day 2]
Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome
- Severity score measured by Sequential Organ Failure Assessment (SOFA) score [Day 7]
Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome
- Severity score measured by Sequential Organ Failure Assessment (SOFA) score [Day of hospital discharge, an average of 1 month]
Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome
- Severity score measured by Simplified Gravity Index 2 [Day 0]
Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome
- Severity score measured by Simplified Gravity Index 2 [Day 2]
Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome
- Severity score measured by Simplified Gravity Index 2 [Day 7]
Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome
- Severity score measured by Simplified Gravity Index 2 [Day of hospital discharge, an average of 1 month]
Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Toulouse | Toulouse | France | 31100 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Fanny BOUNES, PH, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/20/0026
- 2020-A00593-36