Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 6:19 PM
Study NCT ID:
NCT02033967
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vasodilator-induced Hypovolemia in Living Liver Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'target value of SVV', 'timeFrame': 'during living donor hepatectomy', 'description': 'Target value of SVV is calculated from the linear regression equation that was calculated from scatter plot made with CVP and SVV values during CVP-guided vasodilator induced hypovolemia (validation study).'}], 'secondaryOutcomes': [{'measure': 'surgical field', 'timeFrame': 'during living donor hepatectomy', 'description': '\\<4 point scale\\> Grade l: Very lax IVC and hepatic veins, minimal bleeding at resection plane, very easy to operate Grade ll: Lax IVC and hepatic veins, a little bleeding at resection plane, easy to operate Grade lll: Tense IVC and hepatic veins, appreciable bleeding at resection plane, somewhat difficult to operate Grade lV: Very tense IVC and hepatic veins, profuse bleeding at resection plane, very difficult to operate'}, {'measure': 'use of inotropics', 'timeFrame': 'during living donor hepatectomy'}, {'measure': 'estimated blood loss', 'timeFrame': 'during living donor hepatectomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver donor', 'hepatectomy', 'vasodilator', 'central venous pressure', 'stroke volume variation'], 'conditions': ['CVP and SVV During Living Donor Hepatectomy', 'Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)']}, 'referencesModule': {'references': [{'pmid': '28632543', 'type': 'DERIVED', 'citation': 'Lee J, Kim WH, Ryu HG, Lee HC, Chung EJ, Yang SM, Jung CW. Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial. Anesth Analg. 2017 Aug;125(2):423-430. doi: 10.1213/ANE.0000000000002197.'}]}, 'descriptionModule': {'briefSummary': 'Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. The investigators try to evaluate the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced hypovolemia using the SVV calculated from the validation study will be tested (feasibility study).', 'detailedDescription': 'This is a 2-phases study.\n\nfirst phase validation study : Evaluation of the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia\n\nsecond phase feasibility study\n\n: Comparison of the surgical field grade between validation study group(CVP guided group) and feasibility study group(SVV guided group)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (20-60 yr)\n* elective living liver donors\n\nExclusion Criteria:\n\n* not obtained informed consent'}, 'identificationModule': {'nctId': 'NCT02033967', 'briefTitle': 'Vasodilator-induced Hypovolemia in Living Liver Donors', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique', 'orgStudyIdInfo': {'id': 'MLN_SVV_CVP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CVP', 'description': 'Central venous pressure-guided vasodilator-induced hypovolemia', 'interventionNames': ['Procedure: vasodilator induced hypovolemia']}, {'type': 'EXPERIMENTAL', 'label': 'SVV', 'description': 'stroke volume variation-guided vasodilator-induced hypovolemia', 'interventionNames': ['Procedure: vasodilator induced hypovolemia']}], 'interventions': [{'name': 'vasodilator induced hypovolemia', 'type': 'PROCEDURE', 'otherNames': ['Milrinone induced hypovolemia'], 'armGroupLabels': ['CVP', 'SVV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Chul-Woo Jung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}