Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-03 @ 9:03 AM
Study NCT ID:
NCT00468793
Status:
COMPLETED
Last Update Posted:
2009-06-10
First Post:
2007-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-05', 'studyFirstSubmitDate': '2007-05-02', 'studyFirstSubmitQcDate': '2007-05-02', 'lastUpdatePostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': 'postoperative day 30'}], 'secondaryOutcomes': [{'measure': 'serum creatinine', 'timeFrame': 'postoperative day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['central venous saturation', 'bowel surgery', 'morbidity', 'intravenous infusions'], 'conditions': ['Perioperative Care']}, 'descriptionModule': {'briefSummary': 'Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided by central venous oxygen saturation. The primary outcome will be complications after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective bowel surgery,\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Coagulation defect,\n* Renal failure,\n* Valvular stenosis'}, 'identificationModule': {'nctId': 'NCT00468793', 'briefTitle': 'Traditional Versus ScvO2 Guided Perioperative Fluid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy', 'orgStudyIdInfo': {'id': '16312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Fluid therapy guided by blood pressure and urine production', 'interventionNames': ['Procedure: Intravenous fluid']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ScvO2 guided fluid therapy', 'interventionNames': ['Procedure: Intravenous fluid']}], 'interventions': [{'name': 'Intravenous fluid', 'type': 'PROCEDURE', 'description': 'The same intravenous fluids will be used in both arms but the volume will be different', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Gro Østgaard, M.D., PH.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Haukeland University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gro Østgaard', 'oldOrganization': 'Haukeland University Hospital'}}}}