Severe Sepsis or Septic Shock Clinical Trial
Official title:
Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?
Many biomarkers have been evaluated in sepsis, especially for prognostic purposes, but none has yet been shown to have sufficient sensitivity or specificity for routine use in clinical practice. However, highlighting a biomarker facilitating the evaluation of the severity of sepsis remains relevant in a pathology where survival is largely conditioned by the initiation of an early and adapted treatment. Recent evidence suggests that hepcidin, which is the key hormone for systemic regulation of iron metabolism, may be an interesting prognostic biomarker. The synthesis of this peptide is regulated by the iron stocks of the body, erythropoiesis, but also inflammation. The mechanisms inducing the expression of hepcidin during inflammation are multiple: interleukin-6 (IL-6) in particular, pro-inflammatory cytokine is a strong inducer of hepcidin. In addition, its expression is increased by the effect of lipopolysaccharide via Toll-like receptors . In septic patients, elevated levels of hepcidin or pro-hepcidin have been reported . A new role for hepcidin in the control of inflammatory and / or immune response has recently been reported. Thus, in a model of murine septic shock, the deleterious character of a lack of expression of hepcidin could be demonstrated . In humans, hepcidinemia has been shown to be a predictive factor in the development of immunotolerance in hepatic transplant patients. Hepcidin therefore plays a major role in the regulation of the inflammatory and / or immune response and in particular during sepsis. The investigators therefore hypothesize that hepcidin could be the marker of an adverse prognosis in septic patients expressing this
Many biomarkers have been evaluated in sepsis, especially for prognostic purposes, but none
has yet been shown to have sufficient sensitivity or specificity for routine use in clinical
practice. However, highlighting a biomarker facilitating the evaluation of the severity of
sepsis remains relevant in a pathology where survival is largely conditioned by the
initiation of an early and adapted treatment. Recent evidence suggests that hepcidin, which
is the key hormone for systemic regulation of iron metabolism, may be an interesting
prognostic biomarker. The synthesis of this peptide is regulated by the iron stocks of the
body, erythropoiesis, but also inflammation. The mechanisms inducing the expression of
hepcidin during inflammation are multiple: interleukin-6 (IL-6) in particular,
pro-inflammatory cytokine is a strong inducer of hepcidin. In addition, its expression is
increased by the effect of lipopolysaccharide via Toll-like receptors . In septic patients,
elevated levels of hepcidin or pro-hepcidin have been reported . A new role for hepcidin in
the control of inflammatory and / or immune response has recently been reported. Thus, in a
model of murine septic shock, the deleterious character of a lack of expression of hepcidin
could be demonstrated . In humans, hepcidinemia has been shown to be a predictive factor in
the development of immunotolerance in hepatic transplant patients. Hepcidin therefore plays a
major role in the regulation of the inflammatory and / or immune response and in particular
during sepsis. The investigators therefore hypothesize that hepcidin could be the marker of
an adverse prognosis in septic patients expressing this.
Primary endpoint is to evaluate the prognostic value of plasma hepcidin assayed on admission
to intensive care on mortality at D28 in severe sepsis.
Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in
patients with severe sepsis.
In a first step, a search for the hepcidin threshold value with the best sensitivity and
specificity to predict death on D28 will be performed using a receiver operating
characteristics (ROC) curve. This threshold value will be used to evaluate the primary
endpoint and also determine specificity and positive and negative predictive values.
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