Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT05231720
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2021-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mannheim Register of Sepsis and Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'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': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2022-02-08', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'in hospital'}, {'measure': 'all-cause mortality', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '38237636', 'type': 'DERIVED', 'citation': 'Forner J, Weidner K, Rusnak J, Dudda J, Behnes M, Akin I, Schupp T. Prognostic Impact of Left Compared to Right Heart Function in Sepsis and Septic Shock. ASAIO J. 2024 Jun 1;70(6):502-509. doi: 10.1097/MAT.0000000000002131. Epub 2024 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.', 'detailedDescription': "All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, baseline parameters, and comorbidities are collected. Extensive information about echocardiography, electrocardiography, and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2,3, 5,7, and 10). Standard scores for critically ill patients were calculated for the day before admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality, and septic patients' 1-year mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes internal medicine patients presenting sepsis and septic shock at the ICU irrespective of the septic focus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sepsis and septic shock according to current guidelines\n\nExclusion Criteria:\n\n* other forms of shock not associated with an infection'}, 'identificationModule': {'nctId': 'NCT05231720', 'acronym': 'MARSS', 'briefTitle': 'Mannheim Register of Sepsis and Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Mannheim Register of Sepsis and Septic Shock', 'orgStudyIdInfo': {'id': '2019-694N'}}, 'contactsLocationsModule': {'locations': [{'zip': '76149', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Behnes', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '+496213836239'}], 'facility': 'University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ibrahim Akin, MD, PhD', 'role': 'CONTACT', 'email': 'ibrahim.akin@umm.de', 'phone': '0049621-3836239'}, {'name': 'Michael Behnes, MD, PhD', 'role': 'CONTACT', 'email': 'michael.behnes@umm.de', 'phone': '0049621-3836239'}, {'name': 'Kathrin Weidner, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Department of Medicine, University Medical Centre Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Michael Behnes', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}