Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-28 @ 6:42 AM
Study NCT ID:
NCT06355466
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2023-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2023-12-23', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one year patency rate of hemodialysis catheters', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation'}], 'secondaryOutcomes': [{'measure': 'one year patency rate of hemodialysis catheters in age subgroups', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation in age subgroups'}, {'measure': 'one year patency rate of hemodialysis catheters in diabetic patients', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation in diabetic patients'}, {'measure': 'one year patency rate of hemodialysis catheters in hypertensive patients', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation in hypertensive patients'}, {'measure': 'one year patency rate of hemodialysis catheters in patients on antiplatelet drugs', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation in patients on antiplatelet drugs'}, {'measure': 'one year patency rate of hemodialysis catheters in sex subgroups', 'timeFrame': 'one year', 'description': 'percent of catheters remained patent one year after their implantation in sex subgroups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Tunneled catheter', 'Patency', 'Antiplatelet'], 'conditions': ['Vascular Access Devices']}, 'referencesModule': {'references': [{'pmid': '33752206', 'type': 'RESULT', 'citation': 'Thurlow JS, Joshi M, Yan G, Norris KC, Agodoa LY, Yuan CM, Nee R. Global Epidemiology of End-Stage Kidney Disease and Disparities in Kidney Replacement Therapy. Am J Nephrol. 2021;52(2):98-107. doi: 10.1159/000514550. Epub 2021 Mar 22.'}, {'pmid': '33652433', 'type': 'RESULT', 'citation': 'Ikizler TA, Cuppari L. The 2020 Updated KDOQI Clinical Practice Guidelines for Nutrition in Chronic Kidney Disease. Blood Purif. 2021;50(4-5):667-671. doi: 10.1159/000513698. Epub 2021 Mar 2.'}, {'pmid': '35210738', 'type': 'RESULT', 'citation': 'El Khudari H, Ozen M, Kowalczyk B, Bassuner J, Almehmi A. Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications. Semin Intervent Radiol. 2022 Feb 18;39(1):90-102. doi: 10.1055/s-0042-1742346. eCollection 2022 Feb.'}, {'pmid': '32891307', 'type': 'RESULT', 'citation': 'Boubes K, Shaikh A, Alsauskas Z, Dwyer A. New Directions in Ensuring Catheter Safety. Adv Chronic Kidney Dis. 2020 May;27(3):228-235. doi: 10.1053/j.ackd.2020.02.004.'}, {'pmid': '12745728', 'type': 'RESULT', 'citation': 'Obialo CI, Conner AC, Lebon LF. Maintaining patency of tunneled hemodialysis catheters--efficacy of aspirin compared to warfarin. Scand J Urol Nephrol. 2003;37(2):172-6. doi: 10.1080/00365590310008938.'}, {'pmid': '36251438', 'type': 'RESULT', 'citation': 'Yaxley J. Haemodialysis catheters - a review of design and function. Expert Rev Med Devices. 2022 Oct;19(10):757-762. doi: 10.1080/17434440.2022.2132148. Epub 2022 Nov 3.'}, {'pmid': '30876612', 'type': 'RESULT', 'citation': 'Kumbar L, Yee J. Current Concepts in Hemodialysis Vascular Access Infections. Adv Chronic Kidney Dis. 2019 Jan;26(1):16-22. doi: 10.1053/j.ackd.2018.10.005.'}, {'pmid': '37311842', 'type': 'RESULT', 'citation': 'Braet P, Van Holsbeeck A, Buyck PJ, Laenen A, Claes K, De Vusser K, Maleux G. Comparison of Clinical Performance Between Two Types of Symmetric-Tip Hemodialysis Catheters: A Single-Centre, Randomized Trial. Cardiovasc Intervent Radiol. 2023 Aug;46(8):983-990. doi: 10.1007/s00270-023-03476-0. Epub 2023 Jun 13.'}, {'pmid': '21115628', 'type': 'RESULT', 'citation': 'Besarab A, Pandey R. Catheter management in hemodialysis patients: delivering adequate flow. Clin J Am Soc Nephrol. 2011 Jan;6(1):227-34. doi: 10.2215/CJN.04840610. Epub 2010 Nov 29.'}, {'pmid': '31704426', 'type': 'RESULT', 'citation': 'Agha R, Abdall-Razak A, Crossley E, Dowlut N, Iosifidis C, Mathew G; STROCSS Group. STROCSS 2019 Guideline: Strengthening the reporting of cohort studies in surgery. Int J Surg. 2019 Dec;72:156-165. doi: 10.1016/j.ijsu.2019.11.002. Epub 2019 Nov 6.'}, {'pmid': '30421638', 'type': 'RESULT', 'citation': 'Coker MA, Black JR, Li Y, Varma R, Almehmi A, Abdel Aal AK, Gunn AJ. An analysis of potential predictors of tunneled hemodialysis catheter infection or dysfunction. J Vasc Access. 2019 Jul;20(4):380-385. doi: 10.1177/1129729818809669. Epub 2018 Nov 13.'}, {'pmid': '33016167', 'type': 'RESULT', 'citation': 'Xiong Y, Yu Y, Yang Y, Wang L, Shi P, Deng Y, Li Y, Fu P. Impacts of age, diabetes, gender, and access type on costs associated with vascular access among Chinese patients on hemodialysis. Int J Artif Organs. 2021 May;44(5):302-309. doi: 10.1177/0391398820962112. Epub 2020 Oct 4.'}, {'pmid': '25198820', 'type': 'RESULT', 'citation': 'Valliant AM, Chaudhry MK, Yevzlin AS, Astor B, Chan MR. Tunneled dialysis catheter exchange with fibrin sheath disruption is not associated with increased rate of bacteremia. J Vasc Access. 2015 Jan-Feb;16(1):52-6. doi: 10.5301/jva.5000301. Epub 2014 Sep 2.'}, {'pmid': '28135701', 'type': 'RESULT', 'citation': 'Shi M, Cui T, Ma L, Zhou L, Fu P. Catheter Failure and Mortality in Hemodialysis Patients with Tunneled Cuffed Venous Catheters in a Single Center. Blood Purif. 2017;43(4):321-326. doi: 10.1159/000455062. Epub 2017 Jan 31.'}, {'pmid': '23871694', 'type': 'RESULT', 'citation': 'Shingarev R, Barker-Finkel J, Allon M. Natural history of tunneled dialysis catheters placed for hemodialysis initiation. J Vasc Interv Radiol. 2013 Sep;24(9):1289-94. doi: 10.1016/j.jvir.2013.05.034. Epub 2013 Jul 18.'}, {'pmid': '30010473', 'type': 'RESULT', 'citation': 'Wojtowicz D, Cholewa D, Faba AM, Domanska B, Kokoszka J, Kopacz K, Ficek R, Irzyniec T, Rotkegel SE, Chudek J. Diabetes decreases patency of tunneled catheters in hemodialysis patients after first effective thrombolysis with urokinase. Ren Fail. 2018 Nov;40(1):384-389. doi: 10.1080/0886022X.2018.1487856.'}, {'pmid': '23022428', 'type': 'RESULT', 'citation': 'Palmer SC, Di Micco L, Razavian M, Craig JC, Ravani P, Perkovic V, Tognoni G, Graziano G, Jardine M, Pellegrini F, Nicolucci A, Webster A, Strippoli GF. Antiplatelet therapy to prevent hemodialysis vascular access failure: systematic review and meta-analysis. Am J Kidney Dis. 2013 Jan;61(1):112-22. doi: 10.1053/j.ajkd.2012.08.031. Epub 2012 Sep 28.'}, {'pmid': '29804743', 'type': 'RESULT', 'citation': 'Yang H, Chen F, Jiao H, Luo H, Yu Y, Hong HG, Li Y, Fu P, Cui T. Management of tunneled-cuffed catheter-related right atrial thrombosis in hemodialysis patients. J Vasc Surg. 2018 Nov;68(5):1491-1498. doi: 10.1016/j.jvs.2018.02.039. Epub 2018 May 24.'}, {'pmid': '23841041', 'type': 'RESULT', 'citation': 'Mozafar M, Samsami M, Sobhiyeh MR, Jabbehdari S, Fallah Zavareh M. Effectiveness of aspirin on double lumen permanent catheter efficacy in ESRD. Nephrourol Mon. 2013 Spring;5(2):762-5. doi: 10.5812/numonthly.8733. Epub 2013 Mar 30.'}, {'pmid': '17890252', 'type': 'RESULT', 'citation': 'Fry AC, Stratton J, Farrington K, Mahna K, Selvakumar S, Thompson H, Warwicker P. Factors affecting long-term survival of tunnelled haemodialysis catheters--a prospective audit of 812 tunnelled catheters. Nephrol Dial Transplant. 2008 Jan;23(1):275-81. doi: 10.1093/ndt/gfm582. Epub 2007 Sep 21.'}, {'pmid': '23891045', 'type': 'RESULT', 'citation': 'Engstrom BI, Horvath JJ, Stewart JK, Sydnor RH, Miller MJ, Smith TP, Kim CY. Tunneled internal jugular hemodialysis catheters: impact of laterality and tip position on catheter dysfunction and infection rates. J Vasc Interv Radiol. 2013 Sep;24(9):1295-302. doi: 10.1016/j.jvir.2013.05.035. Epub 2013 Jul 23.'}, {'pmid': '11325679', 'type': 'RESULT', 'citation': 'Weiss MF, Scivittaro V, Anderson JM. Oxidative stress and increased expression of growth factors in lesions of failed hemodialysis access. Am J Kidney Dis. 2001 May;37(5):970-80. doi: 10.1016/s0272-6386(05)80013-7.'}]}, 'descriptionModule': {'briefSummary': "In this prospective cross-sectional study, patients with ESRD unfit for AVF/AVG were scheduled for a right or left trans-jugular tunneled catheter placement. All patients were asked about their catheters' function one year after its implantation and the presumed affecting factors on catheters' patency were evaluated.", 'detailedDescription': "In this prospective cross-sectional study, the population consisted of patients with end-stage renal failure who were undergoing chronic hemodialysis from 2021-2022 in Golestan province. Patients with end-stage renal failure who were candidates to start or continue dialysis through tunneled catheters as permanent access were included in the study.\n\nAccording to the 2019 KDOQI guideline, all of the patients were excluded from AVF/ AVG implantation because of one or more of these reasons: heart failure, failed AVF/AVG with no remaining viable option for new AVF/AVG construction, absence of suitable artery/ vein for AVF or AVG construction, patient's preference despite understanding the superiority of AVF/AVG to catheters.\n\nWritten informed consent was obtained from all of the patients for conduction and publication of the study.\n\nIn all patients, the priority was to insert the catheter through the right jugular unless their right jugular vein was occluded in the preoperative ultrasound, or if it was not possible to pass the wire through the right jugular vein to the right atrium. In these patients, the left jugular vein was used as the insertion site. In some patients left side catheter insertion was not possible as well. These patients whose catheters were placed somewhere else were excluded from the study. In all cases, the proper location of the catheter tip -at the junction of the superior vena cava with the right atrium- was ensured using intraoperative fluoroscopy with a C-arm. For this purpose, catheters of a tip-to-cuff size of 19 and 23 were installed on the right and left side, respectively. For at least one post-implantation session, proper hemodialysis function of the catheter was ensured. All patients underwent surgery by the same vascular surgeon in a single secondary/teaching public center, and due to the restrictions rendered by economic sanctions, a single brand of catheter was used for all patients. A special questionnaire was utilized to record data on age, gender, underlying diseases (diabetes or high blood pressure), medications, and catheter location. All patients' catheter efficacy was re-evaluated one year later by referring to their hemodialysis center or by calling them, and the adequacy of their catheters was recorded to provide adequate flow for hemodialysis. The affecting factors on catheters' patency were evaluated and analysed using statistical software."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients who need continuous hemodialysis and are not eligible to AVF/AVG implantation were scheduled for trans-jugular, tunneled-catheter implantation and after one session of successful hemodialysis were followed one year later for their catheters' function.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nESRD on chronic hemodialysis Not eligible for AVF/AVG\n\nExclusion Criteria:\n\nNon-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter'}, 'identificationModule': {'nctId': 'NCT06355466', 'briefTitle': 'Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors', 'organization': {'class': 'OTHER', 'fullName': 'Golestan University of Medical sciences'}, 'officialTitle': 'Evaluation of Duration of the Long-term Hemodialysis Catheters Patency and Its Effecting Factors in Chronic Hemodialysis Patients in Golestan Province in 1400-1401', 'orgStudyIdInfo': {'id': '51-112334'}}, 'contactsLocationsModule': {'locations': [{'zip': '4918936316', 'city': 'Gorgan', 'state': 'Golestan Province', 'country': 'Iran', 'facility': 'Golestan University of Medical Sciences, faculty of medicine', 'geoPoint': {'lat': 36.8427, 'lon': 54.44391}}], 'overallOfficials': [{'name': 'Pezhman Kharazm, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'assistant professor of vascular surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Golestan University of Medical sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgeon', 'investigatorFullName': 'Pezhman Kharazm, MD', 'investigatorAffiliation': 'Golestan University of Medical sciences'}}}}