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

Sepsis Clinical Trial

— INFLA-SEPSIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04635878
• Other study ID #: RC31/20/0026
• Secondary ID: 2020-A00593-36
• Status: Recruiting
• Start date: July 27, 2020
• Est. completion date: July 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Toulouse
• Contact: Fanny BOUNES, PH
• Phone: 05 61 32 27 99
• Email: Bounes.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of inflammasome NLRP3 activation	Rate of inflammasome NLRP3 activation (measured in blood samples)	Day 0
Secondary	Rate of inflammasome NLRP3 activation	Rate of inflammasome NLRP3 activation (measured in blood samples)	Day 2
Secondary	Rate of inflammasome NLRP3 activation	Rate of inflammasome NLRP3 activation (measured in blood samples)	Day 7
Secondary	Rate of inflammasome NLRP3 activation	Rate of inflammasome NLRP3 activation (measured in blood samples)	Day of hospital discharge, an average of 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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