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

• Conditions: Sepsis
• Interventions: Other: Blood collection

• Registration Number: NCT04635878
• Lead Sponsor: University Hospital, 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

Study Timeline

• Study Start: 2020-07-27
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Blood collection	patients without infection hospitalized in intensive care unit
Sepsis group	Blood collection	patients suffering from sepsis hospitalized in intensive care unit

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

University Hospital of Toulouse; 🇫🇷 Toulouse, France