Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04448951
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2020-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Homeostasis in Sepsis and Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'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': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D005434', 'term': 'Flow Cytometry'}, {'id': 'D016207', 'term': 'Cytokines'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002469', 'term': 'Cell Separation'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003592', 'term': 'Cytophotometry'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2020-06-23', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response description - flow cytometry', 'timeFrame': '2024 - 2026', 'description': 'Detailed description of immune response analyzed by mean of flow cytometry'}, {'measure': 'Immune response description - transcriptomics', 'timeFrame': '2024 - 2026', 'description': 'Detailed description of immune response analyzed by mean of transcriptomic analysis'}, {'measure': 'Immune response description - ELISA', 'timeFrame': '2024 - 2026', 'description': 'Detailed description of immune response analyzed by mean of ELISA'}], 'secondaryOutcomes': [{'measure': 'Diagnostic "immune status" panel', 'timeFrame': '2026 - 2028', 'description': 'Diagnostic tool for immune status assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'septic shock', 'immune response', 'immunoparalysis', 'transcriptomics', 'flow-cytometry', 'immunomodulation'], 'conditions': ['Sepsis', 'Immunologic Paralysis', 'Immunologic Suppression', 'Immune Deficiency']}, 'descriptionModule': {'briefSummary': 'Detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'sepsis/septic shock according SEPSIS-3 definition', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sepsis/septic shock (SEPSIS-3)\n* age ≥18\n* informed consent\n* inclusion within first 24hrs after development/diagnosis of septic shock\n\nExclusion Criteria:\n\n* disagreement of the patient or legal representative with the entry into the study\n* patients with primary or secondary immunodeficiency\n* presence of active haematological malignancy or an active non-haematological malignancy'}, 'identificationModule': {'nctId': 'NCT04448951', 'acronym': 'IMHOTEP', 'briefTitle': 'Immune Homeostasis in Sepsis and Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Immune Homeostasis in Patients With Sepsis and Septic Shock: a Single Center Observational Study', 'orgStudyIdInfo': {'id': 'IMHOTEP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis/septic shock', 'description': 'target population', 'interventionNames': ['Other: transcriptomics', 'Other: flow-cytometry', 'Other: cytokines']}, {'label': 'non-septic critically ill', 'description': 'demographically-matched control group', 'interventionNames': ['Other: transcriptomics', 'Other: flow-cytometry', 'Other: cytokines']}, {'label': 'healthy control', 'description': 'control group', 'interventionNames': ['Other: transcriptomics', 'Other: flow-cytometry', 'Other: cytokines']}], 'interventions': [{'name': 'transcriptomics', 'type': 'OTHER', 'description': 'transcriptomics', 'armGroupLabels': ['healthy control', 'non-septic critically ill', 'sepsis/septic shock']}, {'name': 'flow-cytometry', 'type': 'OTHER', 'description': 'peripheral blood myeloid cells and lymphocytes flow-cytometry', 'armGroupLabels': ['healthy control', 'non-septic critically ill', 'sepsis/septic shock']}, {'name': 'cytokines', 'type': 'OTHER', 'description': 'peripheral blood cytokine analysis', 'armGroupLabels': ['healthy control', 'non-septic critically ill', 'sepsis/septic shock']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330 01', 'city': 'Pilsen', 'state': 'Česká Republika', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Thomas Karvunidis, MD, Ph.D.', 'role': 'CONTACT', 'email': 'karvunidist@fnplzen.cz', 'phone': '+420 377 103 173'}, {'name': 'Marcela Kralovcova, MD', 'role': 'CONTACT', 'email': 'kralovcovam@fnplzen.cz', 'phone': '+420 377 103 173'}], 'facility': 'Medical ICU, 1st Dept. of Internal Medicine, Teaching Hospital in Pilsen', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}], 'centralContacts': [{'name': 'Thomas Karvunidis, MD, Ph.D.', 'role': 'CONTACT', 'email': 'karvunidist@fnplzen.cz', 'phone': '+420 377 103 173'}, {'name': 'Marcela Královcová, MD', 'role': 'CONTACT', 'email': 'kralovcovam@fnplzen.cz', 'phone': '+420 377 103 173'}], 'overallOfficials': [{'name': 'Thomas Karvunidis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carles University Teaching Hospital and Faculty of Medicine in Pilsen, Pilsen, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Thomas Karvunidis', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}