Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04078620
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2019-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-01', 'studyFirstSubmitDate': '2019-08-25', 'studyFirstSubmitQcDate': '2019-09-01', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Drug interactions by Lexicomp interactions application', 'timeFrame': '6months period', 'description': 'Lexicomp interactions classified As:\n\nA(no known interactions) B(no action needed) C(monitor therapy) D(consider therapy modification) X (avoid combination)'}, {'measure': 'Severity of Drug interactions by Medescape interactions checker:', 'timeFrame': '6months period', 'description': 'Interactions classified with Medescape interactions checker as :(contraindicated, serious use alternative, monitor closely,minor)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Interaction']}, 'descriptionModule': {'briefSummary': 'Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay', 'detailedDescription': 'This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period.\n\nDemographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to Surgical ICUs, zagazig University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to Surgical ICUs for six months period\n\nExclusion Criteria:\n\n* less than one day admission to ICU,not completed data'}, 'identificationModule': {'nctId': 'NCT04078620', 'briefTitle': 'Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals', 'orgStudyIdInfo': {'id': '4606/28-5-2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Survey for drug drug interactions on medscape and lexicomp applications', 'type': 'DIAGNOSTIC_TEST', 'description': 'Survey for drug drug interactions on Medscape and Lexicomp interaction checker applications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33735', 'city': 'Zagazig', 'state': 'Sharquia', 'country': 'Egypt', 'facility': 'Liza Elsayed Ali', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Liza Shallouf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University'}, {'name': 'Heba Matar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'For indefinite time', 'ipdSharing': 'YES', 'description': 'All data could be shared', 'accessCriteria': 'Easy, direct information are available for other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Liza Elsayed Ali soliman shallouf', 'investigatorAffiliation': 'Zagazig University'}}}}