- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682003
Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis? (HEP-SEPSIS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- man or woman,
- older than or equal to 18 years, in severe sepsis or septic shock according to the criteria of the American College of Chest Physicians / Society of Critical Care Medicine (ACCP / SCCM),
- no opposition from the patient, a relative or the legal representative
Exclusion Criteria:
- pregnant or lactating woman,
- patient with hemochromatosis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.
Time Frame: day 28
|
Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.
|
day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality at day 90
Time Frame: day 90
|
mortality at day 90
|
day 90
|
occurrence of care-related infections as defined by the Center for Disease Control and Prevention during hospitalization
Time Frame: day 90
|
occurrence of care-related infections as defined by the Center for Disease Control and Prevention during hospitalization
|
day 90
|
occurrence of new organ failure (SOFA) or the aggravation of an existing organ failure on seventh day of sepsis
Time Frame: day 90
|
occurrence of new organ failure (SOFA) or the aggravation of an existing organ failure on seventh day of sepsis
|
day 90
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC13_9906_HEP-SEPSIS
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