Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT03510650
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051359', 'term': 'Lymphohistiocytosis, Hemophagocytic'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D015616', 'term': 'Histiocytosis, Non-Langerhans-Cell'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '6 ml of blood samples of each patient will be stored in the Biobank of the Berlin Institute of Health, Clinical Research Unit, Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, D-13353 Berlin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HLA Typing', 'timeFrame': 'At the beginning of the investigation', 'description': 'HLA testing identifies the major HLA genes a person has inherited and their corresponding antigens that are present on the surface of their cells.'}], 'primaryOutcomes': [{'measure': 'Incidence of HLH in intensive care units based on HLH-2004 criteria', 'timeFrame': 'Up to 180 days', 'description': 'HLH patients are followed up until the end of hospital stay or death.'}], 'secondaryOutcomes': [{'measure': 'Intensive care unit stay', 'timeFrame': 'Participants will be followed up for the duration of hospital length of stay, an expected average of 4 weeks'}, {'measure': 'Hospital stay', 'timeFrame': 'Participants will be followed up for the duration of hospital length of stay, an expected average of 8 weeks'}, {'measure': 'Mortality', 'timeFrame': 'Up to 180 days', 'description': 'Mortality after 30 and 180 days'}, {'measure': 'Cytokine panel', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample of Cytokine panel (CRP, PCT, IL-1β, IL-6, IL-8, IL-10, IL-18, IL-33, TNF-α, IFN-ɣ, sIL-2R, ferritin) collection at time of diagnosed HLH'}, {'measure': 'Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) viral loads', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample collection at time of diagnosed HLH'}, {'measure': 'Glycosylated ferritin', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample collection at time of diagnosed HLH'}, {'measure': 'microRNAs miR-205-5p, miR-194-5p and miR-30c-5p', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample collection at time of diagnosed HLH'}, {'measure': 'Perforin and CD107a', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample collection at time of diagnosed HLH'}, {'measure': 'Human immunodeficiency virus antibodies and -antigen', 'timeFrame': 'Up to 180 days', 'description': '1 blood sample collection at time of diagnosed HLH'}, {'measure': 'Fibrinogen', 'timeFrame': 'Up to 180 days'}, {'measure': 'Triglycerides', 'timeFrame': 'Up to 180 days'}, {'measure': 'Bilirubin', 'timeFrame': 'Up to 180 days'}, {'measure': 'Lactate dehydrogenase', 'timeFrame': 'Up to 180 days', 'description': 'Lactate dehydrogenase is measured in U/l'}, {'measure': 'Liver transaminase (ASAT)', 'timeFrame': 'Up to 180 days', 'description': 'ASAT \\[U/l\\]'}, {'measure': 'Liver transaminases (ALAT)', 'timeFrame': 'Up to 180 days', 'description': 'ALAT \\[U/l\\]'}, {'measure': 'Sodium', 'timeFrame': 'Up to 180 days'}, {'measure': 'Serum albumin', 'timeFrame': 'Up to 180 days'}, {'measure': 'Serum protein electrophoresis', 'timeFrame': 'Up to 180 days', 'description': 'Serum protein Electrophoresis (%) is used to separate and quantify the serum protein components into serum albumin, alpha-1 globulins, alpha-2 globulins, beta 1 and 2 globulins, and gamma Globulins.'}, {'measure': 'Detailed immune status', 'timeFrame': 'Up to 180 days', 'description': 'The immune status is analyzed by differential blood count \\[/nl\\], T cells \\[/nl\\], B cells \\[/nl\\], NK cells \\[/nl\\], T helper cells \\[/nl\\], cytotoxic T cells \\[/nl\\], CD4 / CD8 ratio, HLA-DR of CD8+ \\[%\\], CD11a of CD8 \\[%\\], CD57 of CD8 \\[%\\], CD28 of CD8+ \\[%\\], HLA-DR of monocytes \\[antigen/cell\\], CD56bright \\[%\\] and CD69 \\[%\\] of NK cells.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemophagocytic Lymphohistiocytosis (HLH)', 'Hemophagocytic syndrome (HPS)', 'critically ill', 'Intensive care unit (ICU)'], 'conditions': ['Hemophagocytic Lymphohistiocytosis']}, 'referencesModule': {'references': [{'pmid': '26705219', 'type': 'BACKGROUND', 'citation': 'Barba T, Maucort-Boulch D, Iwaz J, Bohe J, Ninet J, Hot A, Lega JC, Guerin C, Argaud L, Broussolle C, Jamilloux Y, Richard JC, Seve P. Hemophagocytic Lymphohistiocytosis in Intensive Care Unit: A 71-Case Strobe-Compliant Retrospective Study. Medicine (Baltimore). 2015 Dec;94(51):e2318. doi: 10.1097/MD.0000000000002318.'}, {'pmid': '31666276', 'type': 'DERIVED', 'citation': 'Lachmann G, Knaak C, von Haefen C, Paeschke N, Meisel C, Nyvlt P, Schuster FS, Piper SK, Kruppa J, Vorderwulbecke G, Balzer F, La Rosee P, Schenk T, Unterwalder N, Kolsch U, Lachmann N, Akyuz L, Brunkhorst FM, Volk HD, Keh D, Spies C. Diagnostic biomarkers for adult haemophagocytic lymphohistiocytosis in critically ill patients (HEMICU): a prospective observational study protocol. BMJ Open. 2019 Oct 30;9(10):e032695. doi: 10.1136/bmjopen-2019-032695.'}]}, 'descriptionModule': {'briefSummary': 'Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all cases remain undiagnosed though therapies are available which clearly reduce mortality. The investigators aim to systematically investigate this life-threatening hyperinflammatory syndrome in intensive care units (ICU) in order to detect biomarkers that are highly sensitive and highly specific for HLH in ICU compared to patients with sepsis.', 'detailedDescription': 'The investigators will draw blood samples of 100 patients at the time of diagnosis (each 50 with suspected or diagnosed HLH/sepsis) to determine a cytokine panel (c reactive protein (CRP), procalcitonin (PCT), interleukin (IL) 1β, IL-6, IL-8, IL-10, IL-18, IL-33, tumor necrosis factor (TNF) α, interferon (IFN) ɣ, soluble IL-2 receptor (sIL-2R), the EBV and CMV viral loads, human immunodeficiency virus (HIV) antibodies and -antigen, perforin, fibrinogen, triglycerides, bilirubin, lactate dehydrogenase, liver transaminases, sodium, serum albumin, electrophoresis, glycosylated ferritin, the microRNAs miR-205-5p, miR-194-5p and miR-30c-5p, perforin, CD107a and high immune status (differential blood count, T cells, B cells, NK cells, T helper cells, cytotoxic T cells, CD4 / CD8 ratio, HLA-DR of CD8 +, CD11a of CD8, CD57 of CD8, CD28 of CD8 +, HLA-DR of monocytes, CD56bright and CD69 of NK cells). The results of this study serve the development of new clinical concepts in order to safely diagnose HLH at an early stage, to distinguish from sepsis and to reduce the fatal consequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female critically ill patients admitted to any ICU of the Charité - Universitätsmedizin Berlin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female critically ill patients\n* At least 18 years old\n* Suspected or diagnosed HLH\n\nExclusion Criteria:\n\n* Female patients: Pregnancy\n* Female patients: Breastfeeding'}, 'identificationModule': {'nctId': 'NCT03510650', 'briefTitle': 'Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)', 'orgStudyIdInfo': {'id': 'HEMICU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '50 patients with sepsis versus 50 patients with HLH \\[anticipated\\]'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}