Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-29 @ 3:15 PM
Study NCT ID:
NCT00771966
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2008-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radical Prostatectomy and Perioperative Fluid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-19', 'studyFirstSubmitDate': '2008-10-14', 'studyFirstSubmitQcDate': '2008-10-14', 'lastUpdatePostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate', 'timeFrame': '6 hours'}], 'secondaryOutcomes': [{'measure': 'Investigate intraoperative haemodynamics', 'timeFrame': 'Intraoperative'}]}, 'conditionsModule': {'keywords': ['patients with cancer in the prostate'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The optimal amount of fluid a patient need under surgery is not clear. Both to much and to little fluid can damage the organ functions.\n\nA strategy called "Goal directed therapy", where the fluid amount a patient need is guided by the stroke volume, has shown to minimize post-operative nausea and vomiting.\n\nThe investigators intend to investigate if patients treated after these standards, has a better outcome then patients treated after normal regimes, regarding post-operative orthostatic-intolerance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with cancer in there prostate\n\nExclusion Criteria:\n\n* Patients who don't understand the information\n* ASA \\> III\n* Patients that are under treatment with the drug triazolam\n* Patients with af known renal decease\n* Patients with a psychiatric decease\n* Alcohol abuse\n* Severe haemorrhagic decease\n* Cancer in the mouth,pharynx, larynx or oesophagus"}, 'identificationModule': {'nctId': 'NCT00771966', 'briefTitle': 'Radical Prostatectomy and Perioperative Fluid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Radical Prostatectomy and Perioperative Fluid Therapy', 'orgStudyIdInfo': {'id': 'RCT_PROST_ORTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard treatment', 'interventionNames': ['Procedure: Standard therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SV maximization', 'interventionNames': ['Procedure: Maximization of cardiac stroke volume with fluid infusion']}], 'interventions': [{'name': 'Standard therapy', 'type': 'PROCEDURE', 'description': 'Standard therapy', 'armGroupLabels': ['Standard treatment']}, {'name': 'Maximization of cardiac stroke volume with fluid infusion', 'type': 'PROCEDURE', 'description': 'Maximization of cardiac stroke volume with fluid infusion', 'armGroupLabels': ['SV maximization']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept of anesthesiology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Morten Bundgaard-Nielsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}