Septic Shock-induced Immunosuppression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling.
- Who it may be relevant to
- Registry conditions: Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration
Overview
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
Interventions
- Biological Blood sampling
Blood sampling for biomarker measurement
Primary outcome measures
- Major Histocompatibility Complex (MHC) class II expression rate [Time frame: at day 3 post septic shock diagnosis]
Secondary outcome measures (2)
- ICU-acquired infections occurence [Time frame: 28 days post septic shock diagnosis]
- mortality rate [Time frame: 28 days post septic shock diagnosis]
Eligibility 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Edouard Herriot — Lyon
Publications
- Venet M, Bidar F, Derive M, Delwarde B, Monard C, Hengy B, Jolly L, Rimmele T, Lukaszewicz AC, Monneret G, Venet F. Persistently Elevated Soluble Triggering Receptor Expressed on Myeloid Cells 1 and Decreased Monocyte Human Leucocyte Antigen DR Expression Are Associated With Nosocomial Infections in Septic Shock Patients. Crit Care Explor. 2023 Feb 24;5(3):e0869. doi: 10.1097/CCE.0000000000000869. PMID 36861044
- Coudereau R, Gossez M, Py BF, Henry T, Lukaszewicz AC, Monneret G, Venet F. Monitoring NLRP3 Inflammasome Activation and Exhaustion in Clinical Samples: A Refined Flow Cytometry Protocol for ASC Speck Formation Measurement Directly in Whole Blood after Ex Vivo Stimulation. Cells. 2022 Oct 20;11(20):3306. doi: 10.3390/cells11203306. PMID 36291172
Identifiers
NCT: NCT04067674 · 69HCL19_0071