Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:40 PM
Study NCT ID:
NCT02547467
Status:
UNKNOWN
Last Update Posted:
2015-09-11
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOADS Study: TO Assess Death From Septic Shock.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016021', 'term': 'Epidemiologic Studies'}], 'ancestors': [{'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2015-07-08', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.', 'timeFrame': 'Patients will be followed during their hospital stay, with a maximal follow up of 90 days', 'description': 'Recording of the context and the cause of death with a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mortality'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .', 'detailedDescription': "The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients who had died of septic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient\n* Died of septic shock in the intensive care unit (ICU)\n* At least 6 hours of vasopressors\n\nExclusion Criteria:\n\n* Legally protected adult patient.\n* Less than 6 hours of vasopressors\n* Opposition to participation in the study expressed by the patient, family or person of trust'}, 'identificationModule': {'nctId': 'NCT02547467', 'acronym': 'TOADS', 'briefTitle': 'TOADS Study: TO Assess Death From Septic Shock.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.', 'orgStudyIdInfo': {'id': '49RC14_0223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'epidemiologic study', 'type': 'OTHER', 'description': 'There is no intervention as it is a pure observational study for epidemiologic survey.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pierre ASFAR, MD-PhD', 'role': 'CONTACT', 'email': 'piasfar@chu-angers.fr', 'phone': '+33(0)241353815'}], 'overallOfficials': [{'name': 'Pierre ASFAR, MD-PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University hospital, Angers, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Laboratoire français de Fractionnement et de Biotechnologies', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}