Innate Lymphoid Cells in Septic Shock

NCT ID: NCT03297203

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-02
• Study Completion Date: 2023-08-09

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).

Conditions

Septic Shock

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

groupe1

patients in septic shock (group 1) in the medical intensive care unit of the Timone Hospital.

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: BEHAVIORAL

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).

groupe 2

patients with a bacterial sepsis alone, during a 6 months period.

Group Type: ACTIVE_COMPARATOR

Blood sample

Intervention Type: BEHAVIORAL

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).

Interventions

Blood sample

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud VANNESTE

Role: STUDY_DIRECTOR

Assistance Publisque Hôpitaux de Marseille

Locations

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31616411 (View on PubMed)

Other Identifiers

2017-24

Identifier Type: -

Identifier Source: org_study_id