Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT00860704
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2009-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Fluid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2009-03-11', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'different hemodynamic fluid responses in the different groups', 'timeFrame': 'every 10 minutes during surgery'}], 'secondaryOutcomes': [{'measure': 'Subcutaneous oxygen tension (PsqO2)', 'timeFrame': 'every 10 minutes during surgery and 2 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['goal directed fluid therapy', 'lean patients', 'obese patients', 'crystalloids', 'Esophageal Doppler', 'tissue oxygenation', 'Fluid management during surgery', 'Fluid management'], 'conditions': ['Goal Directed Fluid Therapy']}, 'referencesModule': {'references': [{'pmid': '12357146', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.'}]}, 'descriptionModule': {'briefSummary': 'Intraoperative fluid demand will be monitored by Esophageal Doppler in lean and obese patients.', 'detailedDescription': 'To our knowledge no data are available on the effect of goal-directed fluid therapy on hemodynamics in lean patients and obese patients, respectively. Consequently, we want to compare lean patients (BMI \\<25) vs. obese patients (BMI \\>25) in regard of their respective needs for intraoperative fluid therapy, and the impact of the goal-directed fluid regimen on tissue oxygenation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients (18 - 80 years) undergoing elective gynecological open surgery (hysterectomy, ovarian cysts and tumors, myomectomy, endometriosis)\n\nExclusion Criteria:\n\n* cardiac insufficiency (EF\\< 35%)\n* renal insufficiency (creatinin clearance \\<30ml/min, dialysis)\n* insulin dependant diabetes mellitus\n* coagulopathy\n* NYHA IV\n* infection\n* sepsis\n* history of suspect malignant hyperthermia\n* porphyria'}, 'identificationModule': {'nctId': 'NCT00860704', 'acronym': 'FLO1', 'briefTitle': 'Goal Directed Fluid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Intraoperative Goal Directed Fluid Therapy in Lean and Obese Patients', 'orgStudyIdInfo': {'id': 'EK 299/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ringerlactate lean', 'description': 'fluidtherapy with crystalloids in lean patients', 'interventionNames': ['Drug: fluidotherapy with ringer-lactate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringerlactate overweight', 'description': 'fluidtherapy with crystalloids in overweight patients', 'interventionNames': ['Drug: fluidotherapy with ringer-lactate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ringerlactate obese', 'description': 'fluidtherapy with crystalloids in obese patients', 'interventionNames': ['Drug: fluidotherapy with ringer-lactate']}], 'interventions': [{'name': 'fluidotherapy with ringer-lactate', 'type': 'DRUG', 'description': 'a bolus of 250ml ringer-lactate is administered, if there is fluid demand monitored by the Esophageal Doppler', 'armGroupLabels': ['Ringerlactate lean', 'Ringerlactate obese', 'Ringerlactate overweight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Andrea Holzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Andrea Holzer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}