Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-27 @ 11:59 AM
Study NCT ID:
NCT01741818
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2012-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012771', 'term': 'Shock, Hemorrhagic'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2012-12-03', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IVC collapsibility index', 'timeFrame': 'within the first 5 minutes'}], 'secondaryOutcomes': [{'measure': 'Serum lactate level', 'timeFrame': 'within the first 5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVC', 'ultrasonography', 'IVC collapsibility index', 'IVC diameter'], 'conditions': ['IVC Collapsibility Index', 'Hemorrhagic Shock']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cases in hypovolemic hemorrhagic status (class II or more) that presented to our ED', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.\n\nExclusion Criteria:\n\n* a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.'}, 'identificationModule': {'nctId': 'NCT01741818', 'briefTitle': 'The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'IUMS-14746'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group B', 'description': 'CVP less than 8cmH2o', 'interventionNames': ['Other: Measuring IVC collapsibility index by bedside ultrasonography']}], 'interventions': [{'name': 'Measuring IVC collapsibility index by bedside ultrasonography', 'type': 'OTHER', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}, {'city': 'Kerman', 'state': 'Kerman', 'country': 'Iran', 'facility': 'Kerman University of Medical Sciences', 'geoPoint': {'lat': 30.28321, 'lon': 57.07879}}], 'overallOfficials': [{'name': 'Keihan Golshani, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Isfahan University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Emergency Medicine', 'investigatorFullName': 'Keihan Golshani', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}