Innate Lymphoid Cells in Septic Shock (CriSIs)
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional other trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Minor patient
- Patient with therepeutic limitations
- Bone marrow failure
Sites / Locations
- Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
groupe1
groupe 2
Arm Description
patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital.
patients with a bacterial sepsis alone, during a 6 months period.
Outcomes
Primary Outcome Measures
Secondary infections
Any secondary infection diagnosed in ICU
Secondary Outcome Measures
Full Information
NCT ID
NCT03297203
First Posted
September 26, 2017
Last Updated
August 9, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03297203
Brief Title
Innate Lymphoid Cells in Septic Shock
Acronym
CriSIs
Official Title
Role of Innate Lymphoid Cells in the Immunosuppression of Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
groupe1
Arm Type
Experimental
Arm Description
patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital.
Arm Title
groupe 2
Arm Type
Active Comparator
Arm Description
patients with a bacterial sepsis alone, during a 6 months period.
Intervention Type
Behavioral
Intervention Name(s)
Blood sample
Intervention Description
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).
Primary Outcome Measure Information:
Title
Secondary infections
Description
Any secondary infection diagnosed in ICU
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Minor patient
Patient with therepeutic limitations
Bone marrow failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud VANNESTE
Organizational Affiliation
Assistance Publisque Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31616411
Citation
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.
Results Reference
derived
Learn more about this trial
Innate Lymphoid Cells in Septic Shock
We'll reach out to this number within 24 hrs