Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 5:07 PM
Study NCT ID:
NCT00862966
Status:
UNKNOWN
Last Update Posted:
2009-03-17
First Post:
2009-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Venous Catheter Lock Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019343', 'term': 'Citric Acid'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D002951', 'term': 'Citrates'}, {'id': 'D014233', 'term': 'Tricarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'lastUpdateSubmitDate': '2009-03-13', 'studyFirstSubmitDate': '2009-03-13', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lower incidence of infection', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'lower incidence of thrombosis', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of end stage renal disease\n\nExclusion Criteria:\n\n* Patients refusing randomization'}, 'identificationModule': {'nctId': 'NCT00862966', 'acronym': 'CVCLS', 'briefTitle': 'Central Venous Catheter Lock Solution', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center, Tuzla'}, 'officialTitle': 'Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution', 'orgStudyIdInfo': {'id': 'UMC-02-139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'citrate', 'interventionNames': ['Other: citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'heparin', 'interventionNames': ['Other: heparin']}], 'interventions': [{'name': 'citrate', 'type': 'OTHER', 'description': 'comparison of different catheter lock solutions', 'armGroupLabels': ['citrate']}, {'name': 'heparin', 'type': 'OTHER', 'description': 'comparison of different lock solutions', 'armGroupLabels': ['heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75000', 'city': 'Tuzla', 'state': 'TK', 'country': 'Bosnia and Herzegovina', 'contacts': [{'name': 'Goran Imamovic, MD,PhD', 'role': 'CONTACT', 'email': 'goran_imamovic@bih.net.ba', 'phone': '+387 61 194 131'}, {'name': 'Goran Imamovic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Dialysis', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}], 'centralContacts': [{'name': 'Goran Imamovic, MD, PhD', 'role': 'CONTACT', 'email': 'goran_imamovic@bih.net.ba', 'phone': '+387 61 194 131'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center, Tuzla', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'UNIVERSITY MEDICAL CENTER', 'oldOrganization': 'Department of Dialysis'}}}}