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Septic Shock-induced Immunosuppression (IMMUNOSEPSIS 4)

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ClinicalTrials.gov Identifier: NCT04067674
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.

In this context, the main objectives of IMMUNOSEPSIS 4 study are:

  1. to identify the best biomarkers for sepsis-induced immunosuppression
  2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock

Condition or disease Intervention/treatment
Septic Shock Biological: Blood sampling

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Study Type : Observational
Estimated Enrollment : 305 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : November 21, 2024
Estimated Study Completion Date : November 21, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
Septic shock patients
Patients included in this cohort will have blood sampling for measurement of immune related biomarkers (immunophenotyping, functional tests, messenger ribonucleic acid (mRNA), circulating markers) in circulating blood and their associations with relevant clinical outcomes
Biological: Blood sampling
Blood sampling for biomarker measurement




Primary Outcome Measures :
  1. Major Histocompatibility Complex (MHC) class II expression rate [ Time Frame: at day 3 post septic shock diagnosis ]
    Association between decreased MHC class II expression on monocytes at day 3 post diagnosis and occurrence of secondary ICU-acquired infections


Secondary Outcome Measures :
  1. ICU-acquired infections occurence [ Time Frame: 28 days post septic shock diagnosis ]
    Association between decreased MHC class II expression on monocytes at day 3 post diagnosis and occurrence of secondary Intensive Care Unit (ICU)-acquired infections

  2. mortality rate [ Time Frame: 28 days post septic shock diagnosis ]

Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with septic shock
Criteria

Inclusion Criteria:

  • Age over 18 years
  • Patient admitted to ICU
  • Diagnosis of septic shock within less than 48h at time of screening defined by :
  • Presence of a microbiologically diagnosed or suspected infection
  • Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission
  • Presence of an hyperlactatemia > 2 mmol/L (18 mg/dL) during the first 24h following initiation of vasopressive treatment despite adequate volemic reanimation (30 ml/kg)
  • Blood sample at D3/D4 available (lab working days)
  • Non opposition to study participation obtained from patient or next of kin

Exclusion Criteria:

  • Patient with immunosuppressive treatment or corticoids at immunosuppressive dosage (> 10 mg equivalent prednisone / day and cumulative dosage >700 mg)
  • Onco-hematological disease (ex. Lymphoma, leukemia…) under treatment, or treated within 5 years before inclusion
  • End of chemotherapy within the 6 months prior to inclusion date
  • Solid tumor under chemotherapy or in remission between 2 chemotherapies
  • Aplasia (neutrophils < 500 cells / mm3)
  • Patient with innate or acquired immune deficiency (for example severe combined immunodeficiency, Human Immunodeficiency Virus or Acquired ImmunoDeficiency Syndrome, any stage)
  • Extracorporeal circulation during the month preceding inclusion
  • Participation in an intervention study that could interfere with immune biomarker measurements
  • Pregnant or breastfeeding women
  • Patient with no social security insurance, with restricted liberty or under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067674


Locations
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France
Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Fabienne VENET, PhD    + 33 4 72 11 97 46    fabienne.venet@chu-lyon.fr   
Principal Investigator: Thomas RIMMELE, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04067674    
Other Study ID Numbers: 69HCL19_0071
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation