Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors
NCT ID: NCT06355466
Last Updated: 2024-04-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
156 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-01-09
Study Completion Date
2023-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Temporary vs.Long Term Hemodialysis Catheter on Central Vein Stenosis
NCT04399564
Stenosis of Arteriovenous Dialysis Fistula
UNKNOWN
NA
Hemodialysis in the Elderly (70yrs & Older)
NCT03065972
Kidney Disease
Kidney Failure
Chronic Kidney Disease
UNKNOWN
NA
Percutaneous Translumbar Vs Transhepatic Permcath
NCT05666375
End Stage Renal Disease
NOT_YET_RECRUITING
NA
Creating a Buttonhole Tunnel Track by Repeated Needling of the AV Fistula on the Same Day in Patients on Hemodialysis.
NCT03989141
End-stage Renal Disease (ESRD)
COMPLETED
NA
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
NCT03355508
Arterio-venous Fistula, Puncture, Chronic Desease
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
According 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.
Written informed consent was obtained from all of the patients for conduction and publication of the study.
In 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.
According 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.
Written informed consent was obtained from all of the patients for conduction and publication of the study.
In 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Vascular Access Devices
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
ESRD on chronic hemodialysis Not eligible for AVF/AVG
Exclusion Criteria
Non-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Golestan University of Medical sciences
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pezhman Kharazm, MD
Vascular Surgeon
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pezhman Kharazm, MD
Role: STUDY_DIRECTOR
assistant professor of vascular surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Golestan University of Medical Sciences, faculty of medicine
Gorgan, Golestan Province, Iran
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Iran
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
51-112334
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Impact of Catheter Design on Catheter Survival in Chronic Hemodialysis Patients
NCT01649102
COMPLETED
PHASE4
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients
NCT02747966
COMPLETED
Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
NCT03523260
WITHDRAWN
NA
ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
NCT02675569
UNKNOWN
NA
Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis
NCT06708338
NOT_YET_RECRUITING
NA
Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation
NCT03633435
UNKNOWN
NA
Improving the Outcomes of Peritoneal Dialysis (PD) Catheter Insertion
NCT04034628
UNKNOWN
Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization
NCT02933892
COMPLETED
PHASE4
Results of Cold Stored Allografts in Vascular Access
NCT04446546
COMPLETED
Indicating Direction and Angle for Cannulating of AV-fistula in Hemodialysis Patients
NCT01536548
COMPLETED
NA
Breaking Down Care Process and Patient-level Barriers to Arteriovenous Access Creation Prior to Hemodialysis Initiation
NCT04032613
COMPLETED
NA
Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis
NCT04967859
COMPLETED
PHASE1
Six-month Response Rate According to Two Surgical Techniques (Rotational Atherectomy Versus Angioplasty) to Treat Stenosis of Vascular Accesses in Hemodialysis.
NCT06868901
NOT_YET_RECRUITING
NA
Semi-blunt Needles: is Outcome Better?
NCT00840372
COMPLETED
Blood Purification Therapy With Dual-cannula in Jugular-femoral Venous
NCT05510713
UNKNOWN
NA
Outcomes of Renal Access Arteriovenous Fistulas for Hemodialysis in Patients With Chronic Renal Failure
NCT04386954
COMPLETED
Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis
NCT05670964
TERMINATED
NA
Evaluation of the Radial Artery Deviation And Reimplantation Technique for Primary Hemodialysis Access Creation
NCT02728817
ACTIVE_NOT_RECRUITING
NA
Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China
NCT02272374
UNKNOWN
NA
REtrospective Analysis on the Use of COvered Stents for the Treatment of the Dysfunctional Vascular Access
NCT04897828
UNKNOWN
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
NCT03645720
WITHDRAWN
NA
Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients
NCT03083184
RECRUITING
PHASE3
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
NCT04360694
RECRUITING
NA
BP Variability on the Outcomes of Hemodialysis Vascular Access
NCT04692636
UNKNOWN
Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler
NCT05545267
UNKNOWN