Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-01 @ 6:16 PM
Study NCT ID:
NCT00764192
Status:
COMPLETED
Last Update Posted:
2009-01-13
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D007854', 'term': 'Lead'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-12', 'studyFirstSubmitDate': '2008-09-26', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'influence of hemodialysis on endothelial function as determined by plasma nitrite concentration', 'timeFrame': 'before and after hemodialysis'}], 'secondaryOutcomes': [{'measure': 'influence on hemodialysis on endothelial function as determined by measurement of flow-mediated dilation (FMD) of teh brachial artery using high resolution ultrasound', 'timeFrame': 'before and after hemodialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'Flow-mediated dilation', 'nictric oxide', 'endothelial function'], 'conditions': ['Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '20117459', 'type': 'DERIVED', 'citation': 'Meyer C, Heiss C, Drexhage C, Kehmeier ES, Balzer J, Muhlfeld A, Merx MW, Lauer T, Kuhl H, Floege J, Kelm M, Rassaf T. Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function. J Am Coll Cardiol. 2010 Feb 2;55(5):454-9. doi: 10.1016/j.jacc.2009.07.068.'}]}, 'descriptionModule': {'briefSummary': 'An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD.', 'detailedDescription': 'Cardiovascular complications are the major cause of death in end-stage renal disease (ESRD) patients undergoing chronic haemodialysis (HD).1 During haemodialysis (HD) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 Adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (NO) bioactivity and enhanced formation of oxygen-derived free radicals.7 Given that endothelial dysfunction is at least in part reversible, the assessment of altered NO availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in HD.8 Nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 The rates of NO consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will NO produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 However, the rate of NO scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 This mechanism is believed to be important in various conditions of health and disease.14-16 In ESRD intravascular hemolysis during HD has been described.17-19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older 21 years dependent on HD for more than 6 months\n\nExclusion Criteria:\n\n* known HD associated hypotension intake of nitrate'}, 'identificationModule': {'nctId': 'NCT00764192', 'briefTitle': 'Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Angiologic Study of the Influence of Hemodialysis on Endothelial Function', 'orgStudyIdInfo': {'id': 'EK DD 2022 CM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '14 HD patients are studied before and after a single HD using a polysulphone dialyser.', 'interventionNames': ['Procedure: blood sample', 'Procedure: Flow-mediated dilation (FMD) before and after a single HD']}], 'interventions': [{'name': 'blood sample', 'type': 'PROCEDURE', 'otherNames': ['biochemistry'], 'description': 'blood sample before and after a single HD', 'armGroupLabels': ['1']}, {'name': 'Flow-mediated dilation (FMD) before and after a single HD', 'type': 'PROCEDURE', 'otherNames': ['endothelial function'], 'description': 'measuring of the flow-mediated dilation using high-resolution ultrasound', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Christian Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen University, Medical Clinic I'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Christian Meyer, MD', 'oldOrganization': 'RWTH Aachen University, Medical Clinic I, University Hospital'}}}}