Septic ShockCriSIsNCT03297203
Innate Lymphoid Cells in Septic Shock
A study testing Blood sample in people with Septic Shock, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Blood sample
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2017to 9 Aug 2023
- Phase
- Interventional
- 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
Who may be able to join
- Major patient
- patient admitted to resuscitation for septic shock
- patient admitted to intensive care for a serious condition and with no progressive infection at the time of collection
Who cannot join
- Minor patient
- Patient with therepeutic limitations
- Bone marrow failure
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: Role of Innate Lymphoid Cells in the Immunosuppression of Septic Shock
Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression.
They seem to be players in infectious diseases in animals but their role in human anti-bacterial defense remains unknown.
In this prospective work, the investigators will compare ILCs phenotyping in ICU patients managed for a septic shock, comparing them to ICU patients without any infectious disease on their inclusion. The investigators will also make a large immune mapping in all patients, to place ILCs in the global immune depressed state observed in septic patients.
Read the detailed description
Septic shock is a major public health problem. Even if mortality is decreasing, it's still high. Sepsis is a heterogeneous syndrome that encompasses a gamut of immune responses occurring during the host's response to a serious, life-threatening infection. The immune phenotype in sepsis ranges from proinflammatory (systemic inflammatory response syndrome and cytokine storm syndrome) to anti-inflammatory (immune depressed state). In order to apprehend septic shock as a whole, investigators should made a whole immune mapping in each patient. Within immune mapping of septic shock patients, innate lymphoid cells (ILCs) have never been explored.
ILCs include natural killer (NK) cells and three other main subsets, ILC1, ILC2 and ILC3, referred as to 'helper-like ILCs'. Since their discovery, ILCs have been shown to contribute to wound healing and defense against infection, and studies have revealed critical aspects of their differentiation. They are studied by flow cytometry and much of the role of ILCs remains to be elucidated, especially in humans. Like T Helper cells, investigators think it could exist an imbalance of ILCs in the late course of septic shock which could participate to the immune depressed state and the increase of patients' mortality at this stage.
So, investigators want to realize a whole immune mapping in patients managed for a septic shock focusing particularly on the innate lymphoid cells. investigators think that ILC1s and ILC3s could be increased in the patients' blood in the early course of the disease and could participate to the cytokine storm syndrome. On the contrary, ILC2s could be increased in the late stage of the septic shock, in correlation with the immune suppressed state. investigators will compare the blood rates of ILCs in septic shock with the blood rates of ILCs in patients with a bacterial sepsis but without severity criteria.
investigators will include 30 patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital (RUM - Pr Gainnier) and 30 patients with a bacterial sepsis alone, during a 6 months period. investigatorswill take two kits of blood samples for the group 1, one during the early stage of the septic shock (48 first hours of care) and one during the late stage of the disease (between the fourth and the sixth day). investigators'll take only one kit of blood samples for the group 2. One kit includes one EDTA tube (5 mL) and five Lithium Heparin tubes (25 mL). The immune mapping will be made by Julien Carvelli, a gold medalist resident, in the framework of a Master 2. The analyses will be made in the laboratory of immunology in the Conception Hospital (Pr Vivier's team).
- Conditions
- Septic Shock
- Being tested
- Blood sample
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBehavioural
The investigators will take two kits of blood samples for the group 1, one during the early stage of the septic shock (48 first hours of care) and one during the late stage of the disease (between the fourth and the sixth day). We'll take only one kit of blood samples for the group 2. One kit includes one EDTA tube (5 mL) and five Lithium Heparin tubes (25 mL). The immune mapping will be made by Julien Carvelli, a gold medalist resident, in the framework of a Master 2. The analyses will be made in the laboratory of immunology in the Conception Hospital (Pr Vivier's team).
| Study group | Role | What they receive |
|---|---|---|
| groupe1 | Experimental | patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital. Receives: Behavioral: Blood sample |
| groupe 2 | Active comparator | patients with a bacterial sepsis alone, during a 6 months period. Receives: Behavioral: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary infections
Any secondary infection diagnosed in ICU
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start2 Aug 2017
- Primary completion31 Aug 2019
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud VANNESTE, Study director, Assistance Publisque Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297203
- Sponsor's protocol ID
- 2017-24
- Acronym
- CriSIs
- Status last verified
- Aug 2023
- First submitted
- 26 Sep 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carvelli J, Piperoglou C, Bourenne J, Farnarier C, Banzet N, Demerle C, Gainnier M, Vely F. Imbalance of Circulating Innate Lymphoid Cell Subpopulations in Patients With Septic Shock. Front Immunol. 2019 Sep 20;10:2179. doi: 10.3389/fimmu.2019.02179. eCollection 2019.
PubMed 31616411
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Innate Lymphoid Cells in the Immunosuppression of Septic Shock
- ClinicalTrials.gov ID
- NCT03297203
- Acronym / sponsor ID
- CriSIs / 2017-24
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 29 Sep 2017 (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.
Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression.
They seem to be players in infectious diseases in animals but their role in human anti-bacterial defense remains unknown.
In this prospective work, the investigators will compare ILCs phenotyping in ICU patients managed for a septic shock, comparing them to ICU patients without any infectious disease on their inclusion. The investigators will also make a large immune mapping in all patients, to place ILCs in the global immune depressed state observed in septic patients.
Detailed description
Septic shock is a major public health problem. Even if mortality is decreasing, it's still high. Sepsis is a heterogeneous syndrome that encompasses a gamut of immune responses occurring during the host's response to a serious, life-threatening infection. The immune phenotype in sepsis ranges from proinflammatory (systemic inflammatory response syndrome and cytokine storm syndrome) to anti-inflammatory (immune depressed state). In order to apprehend septic shock as a whole, investigators should made a whole immune mapping in each patient. Within immune mapping of septic shock patients, innate lymphoid cells (ILCs) have never been explored.
ILCs include natural killer (NK) cells and three other main subsets, ILC1, ILC2 and ILC3, referred as to 'helper-like ILCs'. Since their discovery, ILCs have been shown to contribute to wound healing and defense against infection, and studies have revealed critical aspects of their differentiation. They are studied by flow cytometry and much of the role of ILCs remains to be elucidated, especially in humans. Like T Helper cells, investigators think it could exist an imbalance of ILCs in the late course of septic shock which could participate to the immune depressed state and the increase of patients' mortality at this stage.
So, investigators want to realize a whole immune mapping in patients managed for a septic shock focusing particularly on the innate lymphoid cells. investigators think that ILC1s and ILC3s could be increased in the patients' blood in the early course of the disease and could participate to the cytokine storm syndrome. On the contrary, ILC2s could be increased in the late stage of the septic shock, in correlation with the immune suppressed state. investigators will compare the blood rates of ILCs in septic shock with the blood rates of ILCs in patients with a bacterial sepsis but without severity criteria.
investigators will include 30 patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital (RUM - Pr Gainnier) and 30 patients with a bacterial sepsis alone, during a 6 months period. investigatorswill take two kits of blood samples for the group 1, one during the early stage of the septic shock (48 first hours of care) and one during the late stage of the disease (between the fourth and the sixth day). investigators'll take only one kit of blood samples for the group 2. One kit includes one EDTA tube (5 mL) and five Lithium Heparin tubes (25 mL). The immune mapping will be made by Julien Carvelli, a gold medalist resident, in the framework of a Master 2. The analyses will be made in the laboratory of immunology in the Conception Hospital (Pr Vivier's team).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| groupe1 | Experimental | Behavioral: Blood samplepatients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital. |
| groupe 2 | Active comparator | Behavioral: Blood samplepatients with a bacterial sepsis alone, during a 6 months period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patient
- patient admitted to resuscitation for septic shock
- patient admitted to intensive care for a serious condition and with no progressive infection at the time of collection
Key exclusion criteria (3 listed)
- Minor patient
- Patient with therepeutic limitations
- Bone marrow failure
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 sampleThe investigators will take two kits of blood samples for the group 1, one during the early stage of the septic shock (48 first hours of care) and one during the late stage of the disease (between the fourth and the sixth day). We'll take only one kit of blood samples for the group 2. One kit includes one EDTA tube (5 mL) and five Lithium Heparin tubes (25 mL). The immune mapping will be made by Julien Carvelli, a gold medalist resident, in the framework of a Master 2. The analyses will be made in the laboratory of immunology in the Conception Hospital (Pr Vivier's team). | Behavioural | groupe 2, groupe1 |
Primary outcome
Secondary infections
Time frame: 7 days
Any secondary infection diagnosed in ICU
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 14 Aug 2023.
- Derived from this study: PubMed 31616411Carvelli J, Piperoglou C, Bourenne J, Farnarier C, Banzet N, Demerle C, Gainnier M, Vely F. Imbalance of Circulating Innate Lymphoid Cell Subpopulations in Patients With Septic Shock. Front Immunol. 2019 Sep 20;10:2179. doi: 10.3389/fimmu.2019.02179. eCollection 2019.
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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.
Arnaud VANNESTE study director
Assistance Publisque Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Septic Shock, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 3 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 14 Aug 2023. 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?
Secondary infections (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297203, which also lists 1 linked publication.
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 14 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.