SepsisINFLA-SEPSISNCT04635878
INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit
An observational study of Sepsis, run by University Hospital, Toulouse at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood collection
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2020to 30 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in intensive care unit in University Hospital of Toulouse
Who may be able to join
- hospitalized in intensive care unit with central catheter
- age > or = 18 years
- patients suffering from sepsis
- hospitalized from less than72 hours
- hospitalized in intensive care unit with central catheter for other reason than infection
- age > or = 18 years
Who cannot join
- patients with curatorship or guardianship
- pregnant women
- patients suffering from malignant blood disease
- patients suffering from disease associated with NLRP3 inflammasome activation
- CONTROL GROUP:
- patients with infection disease
Show all 10Show fewer
- patients with curatorship or guardianship
- pregnant women
- patients suffering from malignant blood disease
- patients suffering from disease associated with NLRP3 inflammasome activation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Sepsis
- Being tested
- Blood collection
- Keywords
- NLRP3 inflammasome, platelets, cytokines, thrombus, septic shock, sepsis
- Medical subject headings
- Sepsis, Thrombosis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | patients suffering from sepsis hospitalized in intensive care unit Receives: Other: Blood collection | |
| Control group | patients without infection hospitalized in intensive care unit Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From day 0 to the hospital discharge, an average of 1 month
Secondary outcomes (12)
Rate of inflammasome NLRP3 activation
Rate of inflammasome NLRP3 activation (measured in blood samples)
Measured: Day 0
Rate of inflammasome NLRP3 activation
Rate of inflammasome NLRP3 activation (measured in blood samples)
Measured: Day 2
Rate of inflammasome NLRP3 activation
Rate of inflammasome NLRP3 activation (measured in blood samples)
Measured: Day 7
Rate of inflammasome NLRP3 activation
Rate of inflammasome NLRP3 activation (measured in blood samples)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day of hospital discharge, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start27 Jul 2020
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny BOUNES, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635878
- Sponsor's protocol ID
- RC31/20/0026
- Other IDs
- 2020-A00593-36
- Acronym
- INFLA-SEPSIS
- Status last verified
- Sep 2024
- First submitted
- 10 Nov 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of INFLAmmasomes NLRP3 in Platelets and Leukocytes During SEPSIS in Intensive Care Unit (INFLA-SEPSIS)
- ClinicalTrials.gov ID
- NCT04635878
- Acronym / sponsor ID
- INFLA-SEPSIS / RC31/20/0026
- Conditions
- Sepsis
- Keywords
- NLRP3 inflammasome, platelets, cytokines, thrombus, septic shock, sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Other: Blood collectionpatients suffering from sepsis hospitalized in intensive care unit |
| Control group | – | Other: Blood collectionpatients without infection hospitalized in intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care unit in University Hospital of Toulouse
Key inclusion criteria (6 listed)
- hospitalized in intensive care unit with central catheter
- age > or = 18 years
- patients suffering from sepsis
- hospitalized from less than72 hours
- hospitalized in intensive care unit with central catheter for other reason than infection
Key exclusion criteria (10 listed)
- patients with curatorship or guardianship
- pregnant women
- patients suffering from malignant blood disease
- patients suffering from disease associated with NLRP3 inflammasome activation
- patients with infection disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes | Other | Control group, Sepsis group |
Primary outcome
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
12 secondary outcomes
Rate of inflammasome NLRP3 activation
Time frame: Day 0
Rate of inflammasome NLRP3 activation
Time frame: Day 2
Rate of inflammasome NLRP3 activation
Time frame: Day 7
Rate of inflammasome NLRP3 activation
Time frame: Day of hospital discharge, an average of 1 month
Severity score measured by Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 0
Severity score measured by Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 2
Severity score measured by Sequential Organ Failure Assessment (SOFA) score
Time frame: Day 7
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 Simplified Gravity Index 2
Time frame: Day 0
Severity score measured by Simplified Gravity Index 2
Time frame: Day 2
Severity score measured by Simplified Gravity Index 2
Time frame: Day 7
Severity score measured by Simplified Gravity Index 2
Time frame: Day of hospital discharge, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny BOUNES, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.