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NCT Number: NCT04067674

Septic Shock-induced Immunosuppression

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Edouard Herriot

Lyon, 69003, France

Location status: Recruiting

Location contact

Fabienne VENET, PhD

CONTACT

[email protected]

+ 33 4 72 11 97 46

Fabienne VENET, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 24h before or after 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

  • Pregnant or breastfeeding woman
  • Patient with no social security insurance, with restricted liberty or under legal protection
  • Language barrier
  • Patient taking part in interventional study about medicin that could interfere with biologic results

Treatment and study plan

Blood sampling

Biological

Blood sampling for biomarker measurement

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabienne VENET, PhD

CONTACT

[email protected]

04 72 11 97 46

Valérie CERRO, CRA

CONTACT

[email protected]

06 29 357 357

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration

Acronym: IMMUNOSEPSIS 4

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2019
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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