Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-07 @ 12:04 AM
Study NCT ID:
NCT04071067
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anemia of Inflammation and Deficiency Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in hepcidin levels', 'timeFrame': 'Days 0, 3, 7, 14, 21', 'description': 'Hepcidin is a peptide produced by the liver. It acts by binding to ferroportin, the sole exporter of iron. The hepcidin-ferroportin complex is sequestrated in the cytosol of cells followed by its degradation. Ferroportin degradation prevents iron from being exported from the cell.'}], 'primaryOutcomes': [{'measure': 'Change in hemoglobin levels during ICU stay', 'timeFrame': '21 days: day 0=point 1; day 7=point 2; day 14=point 3; day 21 =point 4;'}, {'measure': 'Number of transfusions during ICU stay', 'timeFrame': 'Up to 3 months of hospital stay'}], 'secondaryOutcomes': [{'measure': 'Days spent on ICU', 'timeFrame': 'Up to 3 months of hospital stay'}, {'measure': 'Days spent in hospital', 'timeFrame': 'Up to 3 months'}, {'measure': 'Change in hemoglobin level during hospital stay', 'timeFrame': 'Up to 3 months: week 3=point 1; week 6=point 2; week 9=point 3; week 12=point4'}, {'measure': 'Number of hours of mechanical ventilation during hospital stay', 'timeFrame': 'Up to 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Iron Deficiency', 'Anemia of Chronic Disease']}, 'referencesModule': {'references': [{'pmid': '29090267', 'type': 'BACKGROUND', 'citation': 'Filipescu D, Banateanu R, Beuran M, Burcos T, Corneci D, Cristian D, Diculescu M, Dobrota A, Droc G, Isacoff D, Gosa D, Grintescu I, Lupu A, Mirea L, Posea C, Stanca O, Stefan M, Tomescu D, Tudor C, Ungureanu D, Mircescu G. Perioperative Patient Blood Management Programme. Multidisciplinary recommendations from the Patient Blood Management Initiative Group. Rom J Anaesth Intensive Care. 2017 Oct;24(2):139-157. doi: 10.21454/rjaic.7518.242.fil.'}]}, 'descriptionModule': {'briefSummary': 'Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.\n\nThe Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to ICU during the study period which do not meet any exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients admitted to ICU\n\nICU stay \\>48hours\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Allergy to iron products\n* Anemia requiring massive transfusion in the last 7 days\n* Treatment of iron products in the last 7 days\n* Chronic renal failure with GFR \\<30mL / min or on dialysis\n* Metabolism of iron\n* Pregnant or lactation patients\n* Rheumatic diseases\n* Inflammatory bowel diseases\n* Hematological pathologies\n* Impossibility of performing laboratory tests within 72 hours of admission'}, 'identificationModule': {'nctId': 'NCT04071067', 'acronym': 'AIDA', 'briefTitle': 'Anemia of Inflammation and Deficiency Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Anemia of Inflammation and Deficiency Anemia in Critically Ill Patients; Biological Markers', 'orgStudyIdInfo': {'id': '89/8.04.2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency Clinical County Hospital Group'}, {'label': 'Municipal Clinical Hospital Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'contacts': [{'name': 'Robert Szabo, Resident MD', 'role': 'CONTACT', 'email': 'robsz11@yahoo.com', 'phone': '0040755628255'}, {'name': 'Cristina Petrisor, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Robert Szabo, Resident MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Emergency Clinical County Hospital Cluj Napoca', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'contacts': [{'name': 'Robert Szabo, Resident MD', 'role': 'CONTACT', 'email': 'robsz11@yahoo.com', 'phone': '0040755628255'}, {'name': 'Constantin Bodolea, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mihaela Ene-Cocis, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Municipal Clinical Hospital Cluj', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Robert Szabo, Resident MD', 'role': 'CONTACT', 'email': 'robsz11@yahoo.com', 'phone': '0040755628255'}], 'overallOfficials': [{'name': 'Constantin Bodolea, Md PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Anesthesia Department of University of Medicine and Pharmacy Cluj Napoca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of 2nd Anesthesia Department', 'investigatorFullName': 'Constantin Bodolea', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}