REAnimation Low Immune Status Markers

NCT ID: NCT02638779

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-11
• Study Completion Date: 2018-06-27

Brief Summary

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.

Conditions

Septic Shock; Severe Trauma; Severe Burn; Major Surgery

Keywords

Septic shock; severe trauma; severe burn; major surgery; immunosuppression; Healthcare-Associated Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blood sampling

Blood sampling will be performed in all patients and healthy volunteers

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: BIOLOGICAL

Specific Blood sampling will be performed in patients and healthy volunteers

Interventions

Blood sampling

Specific Blood sampling will be performed in patients and healthy volunteers

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bioaster

OTHER

Sponsor Role: collaborator

BioMérieux

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Anesthésie Réanimation - Hôpital Edouard Herriot

Lyon, , France

Countries

France

References

Rol ML, Venet F, Rimmele T, Moucadel V, Cortez P, Quemeneur L, Gardiner D, Griffiths A, Pachot A, Textoris J, Monneret G; REALISM study group. The REAnimation Low Immune Status Markers (REALISM) project: a protocol for broad characterisation and follow-up of injury-induced immunosuppression in intensive care unit (ICU) critically ill patients. BMJ Open. 2017 Jun 21;7(6):e015734. doi: 10.1136/bmjopen-2016-015734.

Reference Type: RESULT

PMID: 28637738 (View on PubMed)

Venet F, Textoris J, Blein S, Rol ML, Bodinier M, Canard B, Cortez P, Meunier B, Tan LK, Tipple C, Quemeneur L, Reynier F, Leissner P, Vedrine C, Bouffard Y, Delwarde B, Martin O, Girardot T, Truc C, Griffiths AD, Moucadel V, Pachot A, Monneret G, Rimmele T; REALISM study group. Immune Profiling Demonstrates a Common Immune Signature of Delayed Acquired Immunodeficiency in Patients With Various Etiologies of Severe Injury. Crit Care Med. 2022 Apr 1;50(4):565-575. doi: 10.1097/CCM.0000000000005270.

Reference Type: RESULT

PMID: 34534131 (View on PubMed)

Mallet F, Diouf L, Meunier B, Perret M, Reynier F, Leissner P, Quemeneur L, Griffiths AD, Moucadel V, Pachot A, Venet F, Monneret G, Lepape A, Rimmele T, Tan LK, Brengel-Pesce K, Textoris J. Herpes DNAemia and TTV Viraemia in Intensive Care Unit Critically Ill Patients: A Single-Centre Prospective Longitudinal Study. Front Immunol. 2021 Nov 2;12:698808. doi: 10.3389/fimmu.2021.698808. eCollection 2021.

Reference Type: RESULT

PMID: 34795661 (View on PubMed)

Peronnet E, Blein S, Venet F, Cerrato E, Fleurie A, Llitjos JF, Kreitmann L, Terraz G, Conti F, Gossez M, Rimmele T, Textoris J, Lukaszewicz AC, Brengel-Pesce K, Monneret G; REAnimation Low Immune Status Marker (REALISM) Study Group. Immune Profiling Panel Gene Set Identifies Critically Ill Patients With Low Monocyte Human Leukocyte Antigen-DR Expression: Preliminary Results From the REAnimation Low Immune Status Marker (REALISM) Study. Crit Care Med. 2023 Jun 1;51(6):808-816. doi: 10.1097/CCM.0000000000005832. Epub 2023 Mar 14.

Reference Type: RESULT

PMID: 36917594 (View on PubMed)

Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, Rimmele T, Textoris J, Vedrine C, Quemeneur L, Griffiths AD, Tan LK, Venet F, Maucort-Boulch D, Monneret G; REALISM study group. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients. Front Immunol. 2021 Nov 29;12:795052. doi: 10.3389/fimmu.2021.795052. eCollection 2021.

Reference Type: DERIVED

PMID: 34912347 (View on PubMed)

Other Identifiers

2015-A01293-46

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL15_0379

Identifier Type: -

Identifier Source: org_study_id