REAnimation Low Immune Status Markers (REALISM)

Civil Hospices of Lyon

Status

Completed

Conditions

Severe Trauma

Major Surgery

Severe Burn

Septic Shock

Treatments

Biological: Blood sampling

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02638779

2015-A01293-46 (Other Identifier)

69HCL15_0379

Details and patient eligibility

About

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.

Enrollment

552 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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