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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04635878
Acronym
INFLA-SEPSIS
Enrollment
11
Registered
2020-11-19
Start date
2020-07-27
Completion date
2023-05-30
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

NLRP3 inflammasome, platelets, cytokines, thrombus, septic shock, sepsis

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

Interventions

OTHERBlood collection

Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Activation kinetics of the NLRP3 inflammasome during sepsis until its resolutionFrom day 0 to the hospital discharge, an average of 1 monthActivation kinetics of the NLRP3 inflammasome from day 0 to patient discharge measured by the area under curve

Secondary

MeasureTime frameDescription
Rate of inflammasome NLRP3 activationDay 0Rate of inflammasome NLRP3 activation (measured in blood samples)
Severity score measured by Sequential Organ Failure Assessment (SOFA) scoreDay 0Severity 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 2Day 0Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026