Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-03-09 @ 9:28 AM
Study NCT ID:
NCT02221908
Status:
UNKNOWN
Last Update Posted:
2015-09-28
First Post:
2014-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED Decision Making Among Hypotensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-25', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correspondence of resuscitation decision and CVP value', 'timeFrame': 'At patient admission to ED', 'description': 'The non-invasive CVP will be measured at the time of initial ordering decision by the ED physician. Afterwards, its relationship to the decision about whether to start intravenous fluid resuscitation will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Systolic Blood pressure < 100 mm Hg'], 'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. The hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive CVP measurement', 'detailedDescription': "If physicians can make appropriate decisions about the need for fluid resuscitation without CVP measurement, then this skill is worth being passed to physicians in training. Previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling CVP sensors. But now because there is a low risk tool (Venus 1000 System), this study is now practical and safe."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients brough to Hahnemann Hospital ED', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\>=18 years of age who enter the Emergency Department at Hahnemann Hospital with Systolic Blood pressure \\< 100 mm Hg\n\nExclusion Criteria:\n\n* Those patients who are suffering from traumatic injury requiring Level I or Level II trauma evaluations. Example conditions include penetrating injuries to head, torso and proximal extremities.\n* Additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral IVs.\n* Pregnant females will be excluded.\n* Subjects under the age of 18 years will be excluded'}, 'identificationModule': {'nctId': 'NCT02221908', 'briefTitle': 'ED Decision Making Among Hypotensive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mespere Lifesciences Inc.'}, 'officialTitle': 'ED Decision Making Among Hypotensive Patients', 'orgStudyIdInfo': {'id': 'IRB1401002513'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients brought to Hahnemann Hospital ED', 'interventionNames': ['Device: Mespere Venus 1000 CVP System']}], 'interventions': [{'name': 'Mespere Venus 1000 CVP System', 'type': 'DEVICE', 'armGroupLabels': ['Patients brought to Hahnemann Hospital ED']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Neal Handly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mespere Lifesciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}