Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?

NCT03682003 | Unknown DMC

• 1 other identifier: 35RC13_9906_HEP-SEPSIS
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Severe Sepsis or Septic Shock

Outcome Measures

Primary Outcomes (1)

• Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.

  Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.

  day 28

Secondary Outcomes (3)

• mortality at day 90

  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

  day 90

Interventions

blood diagnostic tests DIAGNOSTIC_TEST

blood tests are performed to determine hepcidin, IL-6, CRP, PCT, serum iron, ferritin, transferrin and transferrin saturation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Man or woman, older than or equal to 18 years, with severe sepsis or septic shock according to the criteria of the American College of Chest Physicians / Society of Critical Care Medicine (ACCP / SCCM),

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating woman,
• patient with hemochromatosis.

Sponsors & Collaborators

• Rennes University Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood tests are performed to determine hepcidin, IL-6, CRP, PCT, serum iron, ferritin, transferrin and transferrin saturation

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Nicolas Nesseler, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2014
• Primary Completion: July 12, 2017
• Study Completion: December 1, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09