Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06820905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2025-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperinflammation and Hyperferritinemia in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D000085583', 'term': 'Hyperferritinemia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1962}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-02-06', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hyperferritinemia', 'timeFrame': '2025', 'description': 'trajectory of critically ill patients with significant hyperferritinemia and with regard to its dynamics; ferritin value cutt-off'}], 'secondaryOutcomes': [{'measure': 'etiology and association of hyperferritinemia', 'timeFrame': '2025', 'description': 'etiology and association of hyperferritinemia with infectioius a non-infectious diseases/conditions'}, {'measure': 'mortality a morbidity', 'timeFrame': '2025', 'description': 'mortality a morbidity of patients with significant hyperferritinemia'}, {'measure': 'treatment strategy', 'timeFrame': '2025', 'description': 'association of hyperferritinemia and treatment strategy'}, {'measure': 'stratification', 'timeFrame': '2025', 'description': 'patient stratification according to hyperferritinemia/hyperinflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['criticall illness', 'sepsis', 'ferritin', 'hyperinflammatory syndrome', 'sepsis phenotype'], 'conditions': ['Critical Illness', 'Sepsis', 'Hyperferritinemia', 'Hyperinflammatory Syndrome']}, 'descriptionModule': {'briefSummary': 'Analysing trajectory of critically ill patients with signs of hyperinflammation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'critically ill patients; mix-cases medical ICU population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients\n* admission between 01.01.2020 and 31.12.2024 (5yrs)\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06820905', 'acronym': 'HYFER', 'briefTitle': 'Hyperinflammation and Hyperferritinemia in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Hyperinflammation and Hyperferritinemia in Critically Ill Patients: a Retrospective Observational Single-center Analysis', 'orgStudyIdInfo': {'id': 'HYFER_2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'critically ill patients', 'description': 'critically ill patients admitted to ICU between 01.01.2020 and 31.12.2024'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30460', 'city': 'Pilsen', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Faculty of Medicine and Teaching Hospital, Charles University', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}], 'centralContacts': [{'name': 'Thomas Karvunidis, MD, PhD', 'role': 'CONTACT', 'email': 'karvunidist@fnplzen.cz', 'phone': '+420776160620'}], 'overallOfficials': [{'name': 'Thomas Karvunidis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine and Teaching Hospital, Charles University, Pilsen, Czech Republic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Thomas Karvunidis', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}