Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-20 @ 5:47 PM
Study NCT ID:
NCT03682003
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2018-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood tests are performed to determine hepcidin, IL-6, CRP, PCT, serum iron, ferritin, transferrin and transferrin saturation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.', 'timeFrame': 'day 28', 'description': 'Sensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.'}], 'secondaryOutcomes': [{'measure': 'mortality at day 90', 'timeFrame': 'day 90', 'description': 'mortality at day 90'}, {'measure': 'occurrence of care-related infections as defined by the Center for Disease Control and Prevention during hospitalization', 'timeFrame': 'day 90', 'description': 'occurrence of care-related infections as defined by the Center for Disease Control and Prevention during hospitalization'}, {'measure': 'occurrence of new organ failure (SOFA) or the aggravation of an existing organ failure on seventh day of sepsis', 'timeFrame': 'day 90', 'description': 'occurrence of new organ failure (SOFA) or the aggravation of an existing organ failure on seventh day of sepsis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Severe Sepsis or Septic Shock']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nPrimary endpoint is to evaluate the prognostic value of plasma hepcidin assayed on admission to intensive care on mortality at D28 in severe sepsis.\n\nSensitivity of plasma hepcidin assayed at admission to intensive care on mortality at D28 in patients with severe sepsis.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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),', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* man or woman,\n* 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),\n* no opposition from the patient, a relative or the legal representative\n\nExclusion Criteria:\n\n* pregnant or lactating woman,\n* patient with hemochromatosis.'}, 'identificationModule': {'nctId': 'NCT03682003', 'acronym': 'HEP-SEPSIS', 'briefTitle': 'Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Hepcidin: a Prognostic Marker of Morbidity and Mortality in Severe Sepsis?', 'orgStudyIdInfo': {'id': '35RC13_9906_HEP-SEPSIS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood diagnostic tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood tests are performed to determine hepcidin, IL-6, CRP, PCT, serum iron, ferritin, transferrin and transferrin saturation'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicolas Nesseler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}