Monitoring of Septic Shock-induced Immunosuppression

NCT07698093 | Not Yet Recruiting

• 1 other identifier: 69HCL25_0663
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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. 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).

Conditions

Sepsis

Keywords

SEPSIS; Immune response; Circulating immunoregulatory cells

Outcome Measures

Primary Outcomes (1)

• 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

  Modification of immune parameters compared with normal values in particular proportion of immunoregulatory cells

  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

Study Arms (1)

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).

Biological: Additional tubes during routine blood sample collection

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)

Adult patient with septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will focus on adult patients admitted to the intensive care unit for the management of septic shock, defined according to the SEPSIS-3 criteria

You may qualify if:

• Men or women aged 18 years or over
• Hospitalised patients with septic shock that began less than 48 hours prior to screening, defined by:
• the presence of a diagnosed or suspected site of infection requiring microbiological sampling
• the need for vasopressor therapy to maintain a mean arterial pressure ≥ 65 mm Hg
• hyperlactataemia \> 2 mmol/L (18 mg/dL) within 24 hours of the start of vasopressor therapy despite adequate fluid resuscitation (30 ml/kg).
• A patient or relative who has been informed of the study protocol and has not objected to participating in the study

You may not qualify if:

• Pregnant or breastfeeding women
• People not covered by a social security scheme or similar scheme
• Adults subject to legal guardianship (guardianship, curatorship)
• Patients with a language barrier
• Persons deprived of their liberty by a judicial or administrative decision

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Service d'Anesthésie-Réanimation Groupement Hospitalier Nord Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Service de Médecine Intensive - Réanimation (MIR) Groupement Hospitalier Nord Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire - Groupement Hospitalier Centre

Lyon, 69437, France

Location

Service de Médecine Intensive - Réanimation (MIR) - Groupement Hospitalier Centre

Lyon, 69437, France

Location

Service d'Anesthésie-Réanimation-Médecine Intensive Groupement Hospitalier Sud Hôpital Lyon Sud - Bâtiment 3B

Pierre-Bénite, 69495, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Following samples will be collected for study purpose : a 4 mL EDTA tube, a 2.5 mL heparin tube, a 5 mL CytoChex tube and a 4 mL PAXGENE tube. Samples will be collected a maximum of five times until patient is discharged from intensive care : inclusion, J3, J5, J15, J25. Remaining samples after completion of study analyses will be retained.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

VENET FABIENNE, Pr

CONTACT

+33 4 72 11 97 46; fabienne.venet@chu-lyon.fr

SAUNIER Clarisse

CONTACT

+33 04 27 85 62 64; clarisse.saunier@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

FR (5)