NCT04635878

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

November 10, 2020

Last Update Submit

September 23, 2024

Conditions

Sepsis

Keywords

NLRP3 inflammasomeplateletscytokinesthrombusseptic shocksepsis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Rate of inflammasome NLRP3 activation

    Day 0

  • Rate of inflammasome NLRP3 activation

    Day 2

  • Rate of inflammasome NLRP3 activation

    Day 7

  • Rate of inflammasome NLRP3 activation

    Day of hospital discharge, an average of 1 month

  • Severity score measured by Sequential Organ Failure Assessment (SOFA) score

    Day 0

  • +7 more secondary outcomes

Study Arms (2)

Sepsis group

patients suffering from sepsis hospitalized in intensive care unit

Other: Blood collection

Control group

patients without infection hospitalized in intensive care unit

Other: Blood collection

Interventions

Blood collectionOTHER

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

Control groupSepsis group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in intensive care unit in University Hospital of Toulouse

You may qualify if:

  • hospitalized in intensive care unit with central catheter
  • age \> or = 18 years
  • patients suffering from sepsis
  • hospitalized from less than72 hours

You may not qualify if:

  • patients with curatorship or guardianship
  • pregnant women
  • patients suffering from malignant blood disease
  • patients suffering from disease associated with NLRP3 inflammasome activation
  • CONTROL GROUP:
  • hospitalized in intensive care unit with central catheter for other reason than infection
  • age \> or = 18 years
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France, 31100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected in peripheral blood at the admission in intensive care unit, day two, day seven and at discharge to compare inflammasome NLRP3 and others markers during sepsis and after resolution of the disease.

MeSH Terms

Conditions

SepsisThrombosisShock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fanny BOUNES, PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 19, 2020

Study Start

July 27, 2020

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)