Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 1:19 PM
Study NCT ID:
NCT00998894
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2009-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9846}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day mortality', 'timeFrame': '90-days'}], 'secondaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30-days'}, {'measure': 'Response to alerts', 'timeFrame': 'Intraoperative', 'description': 'Vasopressor administration within 5 minutes or reduction in volatile anesthetic within 15 minutes of Triple Low onset'}, {'measure': 'Hospital-free days within the initial postoperative month', 'timeFrame': '30-days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BIS', 'MAC', 'MAP'], 'conditions': ['Low Bispectral Index', 'Low Mean Arterial Blood Pressure', 'Low End-tidal Anesthetic Concentration']}, 'descriptionModule': {'briefSummary': 'The investigators propose to test the theory that smart alarms for the Triple Low State incorporated into a decision support system built into an electronic anesthesia record will prompt clinicians to intervene earlier in situations that would otherwise provoke little concern, and that the alert system will reduce 90-day mortality. Specifically, the investigators will test the hypothesis that providing Triple Low alerts reduces 90-day mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults presenting for non-cardiac surgery under volatile general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults presenting for non-cardiac surgery under volatile general anesthesia'}, 'identificationModule': {'nctId': 'NCT00998894', 'briefTitle': 'Randomized Trial of Alerts in Patients Demonstrating a "Triple Low"', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Randomized Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a "Triple Low" of Mean-arterial Pressure, End-tidal Anesthetic Concentration, and Bispectral Index', 'orgStudyIdInfo': {'id': '09-453'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'decision-support alerts', 'description': 'In patients experiencing a Triple Low (a combination of low MAC, low MAP, and low BIS), a warning alert will be generated for clinicians.'}, {'label': 'routine practice', 'description': 'In patients experiencing a Triple Low (a combination of low MAC, low MAP, and low BIS), a warning alert will not be generated for clinicians.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Daniel I Sessler, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chair', 'investigatorFullName': 'd sessler', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}