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Completed

NCT Number: NCT04635878

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

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

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Key information

Conditions

Sepsis Cardiovascular Diseases Embolism and Thrombosis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Toulouse

Toulouse, France, 31100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood collection

Other

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

Primary outcomes

  1. Activation kinetics of the NLRP3 inflammasome during sepsis until its resolution

    Time frame: 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 outcomes

  1. Rate of inflammasome NLRP3 activation

    Time frame: Day 0

    Rate of inflammasome NLRP3 activation (measured in blood samples)

  2. Rate of inflammasome NLRP3 activation

    Time frame: Day 2

    Rate of inflammasome NLRP3 activation (measured in blood samples)

  3. Rate of inflammasome NLRP3 activation

    Time frame: Day 7

    Rate of inflammasome NLRP3 activation (measured in blood samples)

  4. Rate of inflammasome NLRP3 activation

    Time frame: Day of hospital discharge, an average of 1 month

    Rate of inflammasome NLRP3 activation (measured in blood samples)

  5. Severity score measured by Sequential Organ Failure Assessment (SOFA) score

    Time frame: Day 0

    Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome

  6. Severity score measured by Sequential Organ Failure Assessment (SOFA) score

    Time frame: Day 2

    Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome

  7. Severity score measured by Sequential Organ Failure Assessment (SOFA) score

    Time frame: Day 7

    Severity score measured by Sequential Organ Failure Assessment (SOFA) score, from 0 to 4; higher score mean worse outcome

  8. Severity score measured by Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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

  9. Severity score measured by Simplified Gravity Index 2

    Time frame: Day 0

    Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome

  10. Severity score measured by Simplified Gravity Index 2

    Time frame: Day 2

    Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome

  11. Severity score measured by Simplified Gravity Index 2

    Time frame: Day 7

    Severity score measured by Simplified Gravity Index 2, score from 0 to 163, higher score mean worse outcome

  12. Severity score measured by Simplified Gravity Index 2

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: INFLA-SEPSIS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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