Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-29 @ 6:01 PM
Study NCT ID:
NCT00431535
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-14', 'studyFirstSubmitDate': '2007-02-05', 'studyFirstSubmitQcDate': '2007-02-05', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Fluid', 'SvO2', 'Mobilisation', 'Orthostatic function'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'It is the purpose of the investigators to investigate the possible relationship between fall in the amount of Oxygen in the blood and disturbances of balance-function before and after surgery.', 'detailedDescription': 'It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid status. It has also been suggested that there is a connection between SvO2 and blood flow in tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.\n\nRecently it has been shown that patients going through heart surgery experience a drop in SvO2 during early mobilization.This drop lasts throughout the mobilisation process.\n\nWe want to investigate whether the same mechanism applies to patients going through other types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic function.\n\nThis will be done by making 3 tests. One pre-operatively,one six hours post-operatively and one 18-24 hours after surgery.\n\nThe tests will consist of:\n\n1. 10 min of rest.\n2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D. 10 min of rest.\n\nBetween each position a venous blood sample will be taken. Also 1 blood sample will be taken at the end of surgery.\n\nContinuous measurements by the Finapres system wil be made throughout the test-sequence to investigate changes in BP, SV, TPR and HR.\n\nAt the same time the patient will be pain-scored when taking a new position.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients going through Radical Prostatectomy, where CVC is standard.\n\nExclusion Criteria:\n\n* Non informed consent\n* ASA \\> II\n* Age less than 18, or more than 80 years\n* Diabetes Mellitus\n* Epidural analgetics\n* Alcohol abuse (investigators assessment)\n* Unable to understand written or spoken information\n* Using beta-blockers'}, 'identificationModule': {'nctId': 'NCT00431535', 'briefTitle': 'Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Descriptive Study Concerning the Connection Between SvO2 and Orthostatic Function Post Operatively', 'orgStudyIdInfo': {'id': 'SvO2'}}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej'}, {'zip': '2200', 'city': 'Copenhagen', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Rigshospitalet'}], 'overallOfficials': [{'name': 'Christoffer Joergensen, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}