Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT01252394
Status:
UNKNOWN
Last Update Posted:
2010-12-03
First Post:
2010-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correspondence of ScO2 and Cardiac Output in Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-05-24', 'releaseDate': '2011-04-27'}, {'resetDate': '2013-04-05', 'releaseDate': '2013-02-25'}], 'estimatedResultsFirstSubmitDate': '2011-04-27'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2010-12-02', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '18638095', 'type': 'BACKGROUND', 'citation': 'Cordtz J, Olde B, Solem K, Ladefoged SD. Central venous oxygen saturation and thoracic admittance during dialysis: new approaches to hemodynamic monitoring. Hemodial Int. 2008 Jul;12(3):369-77. doi: 10.1111/j.1542-4758.2008.00283.x.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmbulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology.\n\nExclusion Criteria:\n\nAge below 18 years. Failure to give informed consent.'}, 'identificationModule': {'nctId': 'NCT01252394', 'briefTitle': 'Correspondence of ScO2 and Cardiac Output in Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Danish State Hospital'}, 'officialTitle': 'ScO2 and Cardiac Output - Correspondence Study in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'ScO2 cardiac output'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen E', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Joakim Cordtz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Copenhagen University Hospital'}], 'centralContacts': [{'name': 'Joakim Cordtz, MD', 'role': 'CONTACT', 'email': 'drcordtz@yahoo.dk', 'phone': '+45 60 85 93 96'}], 'overallOfficials': [{'name': 'Soeren D Ladefoged, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dep. of Nephrology, Copenhagen University Hospital.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Joakim Cordtz/MD', 'oldOrganization': 'Department of Nephrology, Copenhagen University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-04-27', 'type': 'RELEASE'}, {'date': '2011-05-24', 'type': 'RESET'}, {'date': '2013-02-25', 'type': 'RELEASE'}, {'date': '2013-04-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Joakim Cordtz, MD, Danish State Hospital'}}}}