REAnimation Low Immune Status Markers

The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine storm, that participates to occurrence of organ failures and early death, followed by a compensatory anti-inflammatory response leading to immunosuppression, is now well established. This immunomodulating response results in a higher risk of secondary infections and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune status with time is crucial to guide therapy management. Objective of REALISM project is to demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data for septic shock patients, but also by extension to other situations of inflammatory aggressions like severe severe trauma or burns, or major surgery. This project will provide tools to predict occurrence of secondary infections and guide patient management by comparing innovating immunomonitoring tools to reference tests non already adapted to a routine patient management.

Targeted populations are adult patients hospitalized for septic shock, severe trauma (including severe burn) or major surgery and healthy volunteers, whom blood samples will serve to validate reference intervals of the two reference tests.


Eligibility Criteria:
Inclusion criteria for patients

* Patient or next of kin having been informed of the conditions of the study and having signed the informed consent form
* Patient hospitalized for :

  * Septic shock
  * Severe trauma (including severe burn)
  * Major surgery

Inclusion criteria for healthy volunteers

* Normal clinical examination
* Signed informed consent form
* Person with social security insurance

Exclusion criteria for patients

* Patient with severe neutropenia (neutrophil count \<0.5 g/l)
* Patients receiving immunosuppressive therapy
* Patients receiving corticosteroids (IV or Per os)
* Use of therapeutic antibodies
* Hematological disease under treatment, or treated within 5 years before inclusion
* End of chemotherapy within the 6 months prior to inclusion
* Patient with innate or acquired immune deficiency (for example severe combined immunodeficiency, HIV or AIDS, any stage)
* Patients for whom a care limitation was pronounced at time of enrolment
* Anticipated length of stay before discharge from the ICU is estimated at less than 48 hours
* Participation in an intervention study
* Extra-corporeal circulation in the month preceding inclusion in case of cardiac surgery
* Pregnant or breastfeeding women
* Patient with no social security insurance, with restricted liberty or under legal protection

Exclusion criteria for healthy volunteers

* Person with an infectious syndrome during the last 90 days
* Extreme physical stress within the last week
* Person having received within the last 90 days, a treatment based on

  * Antivirals
  * Antibiotics
  * Antiparasitics
  * Antifungics
* Person having received within the last 15 days, a treatment based on non-steroidal anti-inflammatory drugs (NSAIDs)
* Person having received within the last 24 months, a treatment based on

  * Immunosuppressive therapy
  * Corticosteroids (IV or Per os)
  * Therapeutic antibodies
  * Chemotherapy
* History of :

  * innate or acquired immune deficiency
  * Hematological disease
  * Solid tumor
  * Severe chronic disease
  * Surgery or hospitalization within the last 2 years
  * Pregnancy within the last year
* Participation to a phase I clinical assay during the last year
* Pregnant or breastfeeding women
* Person with restricted liberty or under legal protection