NCT02638779: REALISM

REAnimation Low Immune Status Markers

Completed NA Last updated 19 December 2025

What this trial tests

NA trial testing Blood sampling in Septic Shock in 552 participants. Completed in 27 June 2018.

Timeline

11 December 2015

Primary endpoint
27 June 2018

27 June 2018

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	552
Start date	11 December 2015
Primary completion	27 June 2018
Estimated completion	27 June 2018
Sites	1 location across France

Drugs / interventions tested

• Blood sampling — full drug profile →

Conditions studied

• Septic Shock — all drugs for Septic Shock →
• Severe Trauma — all drugs for Severe Trauma →
• Severe Burn — all drugs for Severe Burn →
• Major Surgery — all drugs for Major Surgery →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Septic Shock or Severe Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Rol ML, Venet F, Rimmele T, Moucadel V, et al · · 2017 · cited 39× · PMID 28637738 · DOI 10.1136/bmjopen-2016-015734
2. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients.
   Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, et al · · 2021 · cited 36× · PMID 34912347 · DOI 10.3389/fimmu.2021.795052
3. Herpes DNAemia and TTV Viraemia in Intensive Care Unit Critically Ill Patients: A Single-Centre Prospective Longitudinal Study.
   Mallet F, Diouf L, Meunier B, Perret M, et al · · 2021 · cited 28× · PMID 34795661 · DOI 10.3389/fimmu.2021.698808
4. Concomitant Assessment of Monocyte HLA-DR Expression and Ex Vivo TNF-α Release as Markers of Adverse Outcome after Various Injuries-Insights from the REALISM Study.
   Bidar F, Bodinier M, Venet F, Lukaszewicz AC, et al · · 2021 · cited 19× · PMID 35011836 · DOI 10.3390/jcm11010096
5. PD-L1<sup>+</sup> plasma cells suppress T lymphocyte responses in patients with sepsis and mouse sepsis models.
   Gossez M, Vigneron C, Vandermoeten A, Lepage M, et al · · 2025 · cited 14× · PMID 40155394 · DOI 10.1038/s41467-025-57706-9
6. Identification of a sub-group of critically ill patients with high risk of intensive care unit-acquired infections and poor clinical course using a transcriptomic score.
   Bodinier M, Monneret G, Casimir M, Fleurie A, et al · · 2023 · cited 14× · PMID 37085849 · DOI 10.1186/s13054-023-04436-3
7. Deciphering heterogeneity of septic shock patients using immune functional assays: a proof of concept study.
   Albert Vega C, Oriol G, Bartolo F, Lopez J, et al · · 2020 · cited 11× · PMID 32999313 · DOI 10.1038/s41598-020-73014-2
8. 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.
   Peronnet E, Blein S, Venet F, Cerrato E, et al · · 2023 · cited 10× · PMID 36917594 · DOI 10.1097/ccm.0000000000005832