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

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

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Blood collection

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Fanny BOUNES, PH; Phone Number: +33 05 61 32 27 99; Email: bounes.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31100
    • Recruiting
    • University Hospital of Toulouse
    • Contact: Fanny BOUNES, PH; Phone Number: +33 05 61 32 27 99; Email: bounes.f@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients hospitalized in intensive care unit in University Hospital of Toulouse

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fanny BOUNES, PH, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: septic shock; NLRP3 inflammasome; sepsis; platelets; cytokines; thrombus
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: RC31/20/0026; 2020-A00593-36 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No