Innate Lymphoid Cells in Septic Shock

NCT03297203 | Completed

• 1 other identifier: 2017-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Secondary infections

  Any secondary infection diagnosed in ICU

  7 days

Study Arms (2)

groupe1

EXPERIMENTAL

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

Behavioral: Blood sample

groupe 2

ACTIVE COMPARATOR

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

Behavioral: Blood sample

Interventions

Blood sample 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; groupe1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minor patient
• Patient with therepeutic limitations
• Bone marrow failure

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 31616411 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Arnaud VANNESTE

  Assistance Publisque Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: August 2, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 9, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

FR (1)