AzTrials
AzTrials

Septic ShockREALISMNCT02638779

REAnimation Low Immune Status Markers

A study testing Blood sampling in people with Septic Shock and Severe Trauma, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Septic Shock, Severe Trauma, Severe Burn
What is being tested?
Blood sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
1 siteFrance
Study dates
11 Dec 2015to 27 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service d'Anesthésie Réanimation - Hôpital Edouard Herriot

    Lyon, 69437

Other trials in France

About this study

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.

Being tested
Blood sampling
Keywords
Septic shock, severe trauma, severe burn, major surgery, immunosuppression, Healthcare-Associated Infections
Medical subject headings
Shock, Septic, Wounds and Injuries, Burns, Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingBiological

    Specific Blood sampling will be performed in patients and healthy volunteers

Study groups in NCT02638779
Study groupRoleWhat they receive
Blood samplingExperimentalBlood sampling will be performed in all patients and healthy volunteers
Receives: Biological: Blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients meeting the definition of of injury-induced-immunosuppression

    The immunosuppression status will be determined from two immunological reference tests: (1) lymphocyte proliferation in response to ex vivo T cell stimulation (adaptive immunity) (Poujol et al., 2014) and (2) the production of tumor necrosis factor (TNF) by monocytes in response to ex vivo stimulation by lipopolysaccharide (LPS) (innate immunity) (Duffy et al., 2014). The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers. For this purpose, the definition of immunosuppression will be: an abnormal result in at least one of the two "reference" tests (outside the reference intervals defining normal values), and on at least two consecutive samples. The same reference test must be abnormal in two successive samples examined for the patient to be considered immunosuppressed.

    Measured: Up to 2 months after injury

Secondary outcomes (5)

  1. Proportion of patients with a deficiency of the innate or adaptive immunity

    Intensity of the innate immune deficiency will be measured using the production of TNF by monocytes in response to ex vivo stimulation by LPS (Duffy et al., 2014). Intensity of the adaptive immune deficiency will be measured using the lymphocyte proliferation in response to ex vivo T cell stimulation (Poujol et al., 2014). The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals derived from an independent set of healthy volunteers. We will describe for all groups of patients:

    • The proportion of patients with a deficiency of the innate immunity, defined by an abnormal TNF secretion test result after LPS stimulation, for at least two consecutive samples.
    • The proportion of patients with a deficiency of the adaptive immunity, defined by an abnormal lymphocyte proliferation, for at least two consecutive samples.
    • The proportion of patients with at least one abnormal test on Days 1, 3-4, 5-7, 13/18, 26/36 and 52/68

    Measured: Up to 2 months after injury

  2. Comparison of performance of the reference tests and new biomarkers for the diagnosis of immunosuppression

    Reference tests being non-standardized and cumbersome to implement, and time to results being incompatible with clinical practice, the use of simpler and quicker tests, based on the use of new biomarkers, would allow the individualization of patient management based on the patient's immune status. One of the secondary objectives is to evaluate the performance of new biomarkers compared to the two reference tests to diagnose immunosuppression. Different types of markers and tests will be evaluated: Viral reactivation markers, host-response markers, immune functional assays, immunophenotyping.

    Measured: Up to one week after injury

  3. Correlation between the immunosuppression status and the incidence of healthcare-associated infections

    To evaluate the association between the immunosuppression status as defined in primary objective and the occurrence of secondary infections related to healthcare, the association of the immunosuppression status upon the occurrence of secondary infection will be examined first, and secondly any possible association between the levels of each of the reference tests and the occurrence of secondary infections will be characterized. In this analysis, a secondary infection related to healthcare will be defined as an infection occurring after inclusion in the study, between inclusion and day 28.

    Measured: Up to 28 days after injury

  4. Correlation between immunosuppression and mortality

    We will examine the association between immunosuppression (as defined in the primary objective) and in-hospital mortality. Association will be evaluated par measuring occurrence of mortality at days 14, 28, 60 and 90, in the different groups.

    Measured: Up to 90 days after injury

  5. Comparison of immune status before and after surgery in the population of surgical patients

    The possibility of taking a sample before surgical stress should allow measurements of the impact of the procedure on the host response, and especially on any subsequent onset of immunosuppression. Oncological pathologies and treatments implemented prior to surgery may also be associated with immunosuppression, and for this reason patients hospitalized for cancer surgery will be compared to those hospitalized for vascular surgery. Impact of surgery on immunosuppression will be measured by comparing immune status as defined by the reference tests, in the population of surgical patients before and after surgery.

    Measured: Up to 2 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2015 (estimated)
  2. Study start11 Dec 2015
  3. Primary completion27 Jun 2018
  4. Study completion27 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02638779
Sponsor's protocol ID
69HCL15_0379
Other IDs
2015-A01293-46
Acronym
REALISM
Status last verified
Dec 2025
First submitted
18 Dec 2015
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28637738

  • 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.

    PubMed 34534131

  • 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.

    PubMed 34795661

  • 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.

    PubMed 36917594

  • 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.

    PubMed 34912347

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling in people with Septic Shock and Severe Trauma, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients meeting the definition of of injury-induced-immunosuppression (time frame: Up to 2 months after injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02638779, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in