Clinical trial NCT04635878: INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit
Official title: Study of INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit (INFLA-SEPSIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: NLRP3 inflammasome
platelets
cytokines
thrombus
septic shock
sepsis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in intensive care unit in University Hospital of Toulouse

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

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

Eligibility 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

Primary outcomes:
measure: Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution
timeFrame: From day 0 to the hospital discharge, an average of 1 month
Secondary outcomes:
measure: Rate of inflammasome NLRP3 activation
timeFrame: Day 0
measure: Rate of inflammasome NLRP3 activation
timeFrame: Day 2
measure: Rate of inflammasome NLRP3 activation
timeFrame: Day 7
measure: Rate of inflammasome NLRP3 activation
timeFrame: Day of hospital discharge, an average of 1 month
measure: Severity score measured by Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 0
measure: Severity score measured by Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 2
measure: Severity score measured by Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day 7
measure: Severity score measured by Sequential Organ Failure Assessment (SOFA) score
timeFrame: Day of hospital discharge, an average of 1 month
measure: Severity score measured by Simplified Gravity Index 2
timeFrame: Day 0
measure: Severity score measured by Simplified Gravity Index 2
timeFrame: Day 2
measure: Severity score measured by Simplified Gravity Index 2
timeFrame: Day 7
measure: Severity score measured by Simplified Gravity Index 2
timeFrame: Day of hospital discharge, an average of 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny BOUNES, PH
role: PRINCIPAL_INVESTIGATOR
References: