Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-28 @ 11:23 AM
Study NCT ID:
NCT02692118
Status:
UNKNOWN
Last Update Posted:
2021-06-07
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Mediators in Early Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semaphorin 1 to 7 in plasma of septic patients', 'timeFrame': '12 months', 'description': 'Concentration of Semaphorin in plasma of 60 sepsis patients \\[pg/ml\\].'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '38489236', 'type': 'DERIVED', 'citation': 'Granja T, Kohler D, Tang L, Burkard P, Eggstein C, Hemmen K, Heinze KG, Heck-Swain KL, Koeppen M, Gunther S, Blaha M, Magunia H, Bamberg M, Konrad F, Ngamsri KC, Fuhr A, Keller M, Bernard AM, Haeberle HA, Bakchoul T, Zarbock A, Nieswandt B, Rosenberger P. Semaphorin 7A coordinates neutrophil response during pulmonary inflammation and sepsis. Blood Adv. 2024 Jun 11;8(11):2660-2674. doi: 10.1182/bloodadvances.2023011778.'}]}, 'descriptionModule': {'briefSummary': 'Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.', 'detailedDescription': 'Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive Care patients with septic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic Shock\n\nExclusion Criteria:\n\n* Age \\< 18 \\> 85\n* no consent of caregiver\n* Trauma patients\n* Burn patients\n* Immunosuppression\n* Pregnancy\n* HIV- hepatitis infection'}, 'identificationModule': {'nctId': 'NCT02692118', 'acronym': 'Tusep', 'briefTitle': 'Inflammatory Mediators in Early Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Inflammatory Mediators in Sepsis as Indicator for Infection vs Inflammation', 'orgStudyIdInfo': {'id': 'AnaTubingen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis', 'description': 'Patients with septic shock admitted to ICU'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Rosenberger, MD', 'role': 'CONTACT'}, {'name': 'Helene A Haeberle, MD', 'role': 'CONTACT'}, {'name': 'Peter Rosenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Peter Rosenberger, MD', 'role': 'CONTACT', 'email': 'peter.rosenberger@med.uni-tuebingen.de', 'phone': '+49(0)7071298', 'phoneExt': '6622'}, {'name': 'Helene A Haeberle, MD', 'role': 'CONTACT', 'email': 'helene.haeberle@med.uni-tuebingen.de', 'phone': '+49(0)7071298', 'phoneExt': '6622'}], 'overallOfficials': [{'name': 'Peter Rosenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}