Informations générales (source: ClinicalTrials.gov)
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS) (IMMUNOSEPSIS)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2009
décembre 2016
29 juin 2024
Septic syndromes (systemic inflammatory response associated with infection) remain a
major although largely under-recognized health care problem and represent the first cause
of mortality in intensive care units. 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 immunologic 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 (CMV or 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. Both arms of
immunity (innate and adaptive) are indeed markedly suppressed (including enhanced
leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising
therapeutic avenues are currently emerging from those recent findings such as adjunctive
immunostimulation for the most immunosuppressed patients. The prerequisite for
immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators
capacity in identifying the patients who could benefit from it, as there is no clinical
sign of immune dysfunctions. The main objectives are:
1. to identify the best biomarkers for sepsis-induced immunosuppression and
2. to evaluate ex vivo whether drugs could rejuvenate immune functions.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hopital Edouard Herriot - 69003 - Lyon - France | Guillaume Monneret | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- septic shock is defined by an identifiable site of infection, persisting hypotension
despite fluid resuscitation requiring vasopressor therapy, and evidence of a
systemic inflammatory response
- septic shock is defined by an identifiable site of infection, persisting hypotension
despite fluid resuscitation requiring vasopressor therapy, and evidence of a
systemic inflammatory response
- age < 18
- immunosuppressive disease (HIV, cancer, primary immune deficiency)
- immunosuppressive treatment or corticoid treatment (dosage > 10mg/day or cumulative
dose >700 mg equivalent prednisolone)
- aplasia as defined by number of circulating neutrophils < 500 cells / mm3
- extracorporeal circulation during the month prior ICU admission