Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT02003066
Status:
COMPLETED
Last Update Posted:
2019-01-28
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1 month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluid Therapy', 'Head and Neck Neoplasms', 'Surgical Flaps'], 'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '29574681', 'type': 'DERIVED', 'citation': 'Kim HJ, Kim EJ, Lee HJ, Min JY, Kim TW, Choi EC, Kim WS, Koo BN. Effect of goal-directed haemodynamic therapy in free flap reconstruction for head and neck cancer. Acta Anaesthesiol Scand. 2018 Aug;62(7):903-914. doi: 10.1111/aas.13100. Epub 2018 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection\n\nExclusion Criteria:\n\n* valvular heart disease\n* congestive heart failure\n* liver failure\n* renal failure\n* pregnant woman\n* allergy to hydroxyethyl starch solutions\n* coagulation abnormalities'}, 'identificationModule': {'nctId': 'NCT02003066', 'briefTitle': 'Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard', 'interventionNames': ['Procedure: Standard fluid therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative', 'interventionNames': ['Procedure: Conservative fluid therapy']}], 'interventions': [{'name': 'Standard fluid therapy', 'type': 'PROCEDURE', 'description': 'In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.', 'armGroupLabels': ['Standard']}, {'name': 'Conservative fluid therapy', 'type': 'PROCEDURE', 'description': 'In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.', 'armGroupLabels': ['Conservative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}