Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT00338234
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2006-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-05', 'studyFirstSubmitDate': '2006-06-16', 'studyFirstSubmitQcDate': '2006-06-16', 'lastUpdatePostDateStruct': {'date': '2008-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional iron deficiency', 'timeFrame': 'during the study'}], 'secondaryOutcomes': [{'measure': 'fatigue assessed by the MFI20 score for cardiac surgery patients', 'timeFrame': 'at one day,at seven days and at 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'intensive care', 'cardiac surgery', 'iron metabolism', 'hepcidin'], 'conditions': ['Anemia', 'Intensive Care', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.', 'detailedDescription': 'Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation. The latter is known to interfere with iron metabolism, inducing iron storage instead of using it for hemoglobin synthesis. The discover of a new regulatory hormone of iron metabolism, hepcidin, may help us to better understand the link between inflammation and iron functional deficit. The aim of our study is to observe the variation of usual iron metabolism biological markers and of hepcidin, in order to define the better marker of iron loss in these clinical situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* For the surgery :population 20 yers to 88 years old\n* For the reanimation : population to the 41 years to 85 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anemia (haemoglobin \\< 10 g/dL)\n* Hospitalization in ICU for an expected duration of 7 days or more\n* Or, day one post cardiac surgery\n\nExclusion Criteria:\n\n* Chronic anemia (Hb \\< 9 g/dL for more than one month before hospitalization)\n* Iron metabolism disease'}, 'identificationModule': {'nctId': 'NCT00338234', 'acronym': 'FAIRe', 'briefTitle': 'Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin', 'orgStudyIdInfo': {'id': 'FAIRe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery', 'description': 'Successive cardiac surgery patients'}, {'label': 'Surgical ICU', 'description': 'Successive patients admitted to the surgical ICU for more than 7 days, and experiencing anemia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'APHP, hopital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'sigismond lasocki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Carole Beaumont, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}, {'name': 'Isabelle Boutron, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Société Française d'Anesthésie et de Réanimation", 'class': 'OTHER'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Sigismond LASOCKI', 'oldOrganization': 'CHU BICHAT-Claude BERNARD'}}}}