Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03539718
Status:
UNKNOWN
Last Update Posted:
2018-05-29
First Post:
2017-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2019-01-09', 'unreleaseDate': '2019-01-13'}, {'resetDate': '2019-04-05', 'releaseDate': '2019-01-13'}], 'estimatedResultsFirstSubmitDate': '2019-01-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparative'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2017-07-31', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of inflammation in hemodialysis patients through hemodialysis catheters', 'timeFrame': 'one month', 'description': 'Comparing levels of highly sensitive c-reactive protein and interleukin-6 levels before and after using the drug Urea reduction ratio over sessions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodialysis Catheter Infection', 'Thrombosis; Dialysis Catheter']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'FOGARTY, DAMIAN, and PETER MAXWELL.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of Taurolock-hep500™ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .', 'detailedDescription': 'In this study,investigators will recruit 60 patients with ESRD on regular hemodialysis from hemodialysis units in Ain-Shams university Hospitals, Patients will be recruited to study at the time of catheter insertion.\n\nThey will be randomized into 2 groups. Group 1; 30 Patients will receive unfractionated heparin (5000i.u/ml) after hemodialysis sessions (control group).\n\nGroup 2; 30 Patients will receive Taurolock-hep500™ after hemodialysis sessions. All patients will be subjected to;\n\n1. Full history including history of ESRD and dialysis initiation.\n2. Clinical examination. Aseptic technique will be used in handling with catheters including (sterile gloves, antiseptic solution in dealing with covers and caps topical antibiotics spray and ointment) catheter will be instilled by 10 ml of normal saline in both opening followed by either taurolock hep 500™ or unfractionated heparin 5000 iu/ml.\n\nPatients will be followed up for one month and will be monitored for clinical symptoms and signs of catheter related bacteremia (fever ,rigors, hypotension, sweating ) on the hemodialysis sessions . Also catheter performance will be assessed using the following parameters;\n\n1. Blood flow rate measured by hemodialysis machine blood pump in (ml/min).\n2. Dialysis quality by URR( urea reduction ratio) is a dimensionless number used to quantify dialysis treatment adequacy by calculating difference between urea level before and after hemodialysis session (average of 4 sessions , 1 per each week).\n3. CBC ,markers of inflammation (CRP) baseline and at time of appearance of symptoms and signs of bacteremia in both groups in addition to (IL6) measured by Elisa technique baseline and at time of appearance of symptoms and signs .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients on regular hemodialysis 3sessions/wk.\n2. Recent catheter insertion at beginning of the study.\n3. Both males and females.\n4. Age group ≥ 18 ys.\n\nExclusion Criteria:\n\n1. Patients with intercurrent infections.\n2. Patients with sepsis.\n3. Patients receiving drugs affecting immune system like immunosuppressive drugs.\n4. Patients on antibiotics.'}, 'identificationModule': {'nctId': 'NCT03539718', 'briefTitle': 'Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.', 'orgStudyIdInfo': {'id': 'taurolock hep 500 efficacy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cases', 'description': 'Cases, taurolidine heparin 500 will be used at end of session', 'interventionNames': ['Drug: Taurolidine heparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'Controls, Heparin Sodium 5000 will be given at end of session', 'interventionNames': ['Drug: Heparin Sodium']}], 'interventions': [{'name': 'Taurolidine heparin', 'type': 'DRUG', 'otherNames': ['Tautolock HEP 500'], 'description': 'Taurolock-hep 500 at end of session', 'armGroupLabels': ['cases']}, {'name': 'Heparin Sodium', 'type': 'DRUG', 'otherNames': ['Heparin Sodium 5000'], 'description': 'Heparin sodium 5000 at end of session', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'amr m mansour, Msc', 'role': 'CONTACT', 'email': 'theamr19@gmail.com', 'phone': '1007212824'}, {'name': 'magdy Mohamed Saeed El Sharkawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Magdy Sharkawy, MD', 'role': 'CONTACT', 'email': 'Magdi35@hotmail.com', 'phone': '002010-014-22331'}, {'name': 'Amr Mansour, Msc', 'role': 'CONTACT', 'email': 'Theamr19@gmail.com', 'phone': '00201007212824'}], 'overallOfficials': [{'name': 'Magdy Sharkawy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of nephrology', 'investigatorFullName': 'amr mohamed mansour', 'investigatorAffiliation': 'Ain Shams University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-09', 'type': 'RELEASE'}, {'date': '2019-01-13', 'type': 'UNRELEASE'}, {'date': '2019-01-13', 'type': 'RELEASE'}, {'date': '2019-04-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'amr mohamed mansour, Assistant Lecturer of nephrology, Ain Shams University'}}}}