Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-03-01 @ 9:01 PM
Study NCT ID:
NCT02373735
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2015-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D008353', 'term': 'Mannitol'}, {'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-02-22', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'During operation'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)', 'timeFrame': 'During 30 days after operation', 'description': 'Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death'}, {'measure': 'Length of hospital stay/ICU stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke volume variation', 'radical cystectomy', 'blood loss', 'postoperative complications'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of stroke volume variation (SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.', 'detailedDescription': 'The purpose of this study is to investigate the effect of stroke volume variation(SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. Patients were randomized to fluid management to maintain \\<10% SVV (group A), or to undergo fluid management during radical cystectomy to maintain SVV 10-20% (group B). Intraoperative blood loss and hemodynamic parameters, perioperative laboratory data, and postoperative complications were compared between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bladder cancer patients who received radical cystectomy\n* Patients with American Society of Anesthesiologists physical status scale classification 1, 2\n* Patients who agree with written informed consent\n\nExclusion Criteria:\n\n* Patients with history of arrhythmia, heart failure patients\n* Patients with history of renal failure patients\n* Patients with history of abdominal surgery\n* Patients who received emergency operation\n* Patients who do not agree with study'}, 'identificationModule': {'nctId': 'NCT02373735', 'briefTitle': 'Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy', 'orgStudyIdInfo': {'id': 'S2014-2192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (SVV <10% group)', 'description': "* infuse crystalloid (Hartmann's solution) 6-10 ml/kg/hr continuously during surgery\n* infuse colloid (Volulyte) 200 ml if SVV is ≥ 10% during the surgery\n\nInterventions: crystalloid (Hartmann's solution), colloid (Volulyte)", 'interventionNames': ['Other: crystalloid', 'Other: colloid']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (SVV 10-20% group)', 'description': "* infuse crystalloid (Hartmann's solution) 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy\n* infuse colloid (Volulyte) 200 ml if SVV is \\> 20%\n* infuse mannitol 0.5 g/kg or lasix 5 mg if SVV \\< 10%\n\nInterventions: crystalloid (Hartmann's solution), colloid (Volulyte), mannitol, lasix", 'interventionNames': ['Other: crystalloid', 'Other: colloid', 'Other: mannitol', 'Other: lasix']}], 'interventions': [{'name': 'crystalloid', 'type': 'OTHER', 'otherNames': ["Hartmann's solution"], 'description': 'Group A (SVV \\<10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy', 'armGroupLabels': ['Group A (SVV <10% group)', 'Group B (SVV 10-20% group)']}, {'name': 'colloid', 'type': 'OTHER', 'otherNames': ['volulyte'], 'description': 'Group A (SVV \\<10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is \\> 20%', 'armGroupLabels': ['Group A (SVV <10% group)', 'Group B (SVV 10-20% group)']}, {'name': 'mannitol', 'type': 'OTHER', 'description': 'Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is \\< 10%', 'armGroupLabels': ['Group B (SVV 10-20% group)']}, {'name': 'lasix', 'type': 'OTHER', 'description': 'Group B (SVV 10-20%): infuse lasix 5 mg if SVV is \\< 10%', 'armGroupLabels': ['Group B (SVV 10-20% group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Kug Kim, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Young-Kug Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}