Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-31 @ 10:48 AM
Study NCT ID:
NCT01535534
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2012-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis', 'inflammation', 'diagnosis', 'prognosis', 'survival', 'mortality'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '28793880', 'type': 'DERIVED', 'citation': 'Hamed S, Behnes M, Pauly D, Lepiorz D, Barre M, Becher T, Lang S, Akin I, Borggrefe M, Bertsch T, Hoffmann U. Diagnostic value of Pentraxin-3 in patients with sepsis and septic shock in accordance with latest sepsis-3 definitions. BMC Infect Dis. 2017 Aug 9;17(1):554. doi: 10.1186/s12879-017-2606-3.'}, {'pmid': '25190134', 'type': 'DERIVED', 'citation': 'Behnes M, Bertsch T, Lepiorz D, Lang S, Trinkmann F, Brueckmann M, Borggrefe M, Hoffmann U. Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment. Crit Care. 2014 Sep 5;18(5):507. doi: 10.1186/s13054-014-0507-z.'}]}, 'descriptionModule': {'briefSummary': 'During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.', 'detailedDescription': 'Primary Outcome Measures:\n\nNew diagnostic and prognostic markers for septic patients\n\nEstimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open\n\nIntervention Details:\n\nProcedure: vein puncture comparison of different inflammatory markers in the blood of septic patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from sepsis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SIRS-Criteria\n* Proven Infection\n* One sepsis-induced organ-failure\n* Adults \\< 18 years old\n\nExclusion Criteria:\n\n* Anemia\n* Pregnancy\n* Blood donor in the last 3 month'}, 'identificationModule': {'nctId': 'NCT01535534', 'acronym': 'MaSep', 'briefTitle': 'Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis', 'orgStudyIdInfo': {'id': '2011-384N-MA'}}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Ursula Hoffmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsmedizin Mannheim'}, {'name': 'Michael Behnes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitätsmedizin Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. med. Ursula Hoffmann', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}