Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT03601767
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-25', 'studyFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'at 28 days'}], 'secondaryOutcomes': [{'measure': 'major complications', 'timeFrame': 'at 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'score'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to develop a prognostic tool to assess the risk of dead and major complications in patient admitted to hospital for infection. A detailed database of clinical, biochemical and microbiological data is recorded and each item is analyzed and compared with clinical outcomes to develop a prognostic score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects presenting to the accident and emergency department and admitted to hospital for any infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* al least 18 years old\n* admission to hospital for any infection for more than 72 hours\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03601767', 'briefTitle': 'Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Paolo'}, 'officialTitle': 'Derivation and Validation of a Prognostic Model for Septic Patients at Hospital Admission', 'orgStudyIdInfo': {'id': '38788/2017'}}, 'contactsLocationsModule': {'locations': [{'zip': '20142', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Livio Colombo, MD', 'role': 'CONTACT', 'email': 'livio.colombo@asst-santipaolocarlo.it', 'phone': '+390281844250'}], 'facility': 'Ospedale San Paolo Polo Univesitario - ASST Santi Paolo e Carlo', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Livio Colombo, MD', 'role': 'CONTACT', 'email': 'livio.colombo@asst-santipaolocarlo.it', 'phone': '+390281844250'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Paolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Acute Medicine', 'investigatorFullName': 'Livio Colombo', 'investigatorAffiliation': 'Azienda Ospedaliera San Paolo'}}}}