Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT01403935
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2011-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sepsis Institutional Registry in Hospital Italiano de Buenos Aires
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2011-07-26', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical features, mortality', 'timeFrame': 'Clinical characteristics are evaluated during the acute event and in-hospital mortality and annual monitoring'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Death', 'Severe Sepsis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.', 'detailedDescription': 'The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Over 17 years\n2. Two or more sirs criteria\n3. Active infection\n\nExclusion Criteria:\n\n1. Refusal to register or to the informed consent process\n2. Ambulatory patients'}, 'identificationModule': {'nctId': 'NCT01403935', 'acronym': 'SIR', 'briefTitle': 'Sepsis Institutional Registry in Hospital Italiano de Buenos Aires', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Sepsis Institutional Registry in Hospital Italiano de Buenos Aires', 'orgStudyIdInfo': {'id': '1172'}}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires, Gascon 450', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Diego H Giunta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Diego Hernan Giunta, MD', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}