Monitoring of Septic Shock-induced Immunosuppression

Sponsor
Hospices Civils de Lyon
Study ID
NCT07698093
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Additional tubes during routine blood sample collection — BIOLOGICAL
    Four additional tubes will be collected during the blood sample carried out as part of standard of care : a 4 mL EDTA tube, a 2.5 mL heparin tube, a 5 mL CytoChex tube and a 4 mL PAXGENE tube.These samples will be taken at inclusion, J3, J5, J15, J25 (until patient is discharged from intensive care)

Study Details

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. Recent studies have described the induction of immunoregulatory cells (of myeloid and lymphoid origin) following septic shock and have revealed a similar induction kinetics across all subpopulations of regulatory cells. Nevertheless, these observations need to be confirmed and linked to the underlying mechanisms responsible for the induction of these cells (notably the activation of the inflammasome pathway), which remain largely unknown. IMMUNOSEPSIS 5 study will therefore, as part of a prospective observational study involving a large cohort of patients, demonstrate the concurrent induction of all regulatory cell subpopulations following sepsis and the activation of the hyper-inflammatory response, including the inflammasome pathway. The association between these parameters and patient outcomes will also be assessed (death and/or the occurrence of a secondary infection).

Key Dates

First listed
Jul 13, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Mar 1, 2031
Completion
Dec 1, 2031

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Adult patient with septic shock
    Additional tubes will be collected for the study at the same time as routine blood sample procedure. No specific intervention will be performed for this study. Theses samples will be collected at the following timing : inclusion, J3, J5, J15, J25 (until patient is discharged from intensive care).

Primary Outcome Measure

Study of the mechanisms regulating the immune response during septic shock, and in particular study of regulatory cell subpopulations in a large cohort of adult patients with septic shock [ Time Frame: Inclusion DAY 1 (within the 48 hours of starting vasopressor therapy) Between DAY 3 and DAY 4 Between DAY 5 and DAY 7 Between DAY 15 and DAY 20 Between DAY 25 and DAY 30 ]

Central Contacts

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