Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors

Vascular Access Devices Clinical Trial

Official title:

Evaluation of Duration of the Long-term Hemodialysis Catheters Patency and Its Effecting Factors in Chronic Hemodialysis Patients in Golestan Province in 1400-1401

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06355466
• Other study ID #: 51-112334
• Status: Completed
• Start date: January 9, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: April 2024
• Source: Golestan University of Medical sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 28, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Devices

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golestan University of Medical Sciences, faculty of medicine	Gorgan	Golestan

Sponsors (1)

Lead Sponsor	Collaborator
Golestan University of Medical sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (22)

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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. — View 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. — View 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- — View 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. — View 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. — View 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 — View 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. do — View 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. — View 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. — View 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. — View 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. — View 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-analy — View 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. — View 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. — View 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. — View 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 — View 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. — View 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; — View 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: 10.1177/039139882 — View 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. — View 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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one year patency rate of hemodialysis catheters	percent of catheters remained patent one year after their implantation	one year
Secondary	one year patency rate of hemodialysis catheters in age subgroups	percent of catheters remained patent one year after their implantation in age subgroups	one year
Secondary	one year patency rate of hemodialysis catheters in diabetic patients	percent of catheters remained patent one year after their implantation in diabetic patients	one year
Secondary	one year patency rate of hemodialysis catheters in hypertensive patients	percent of catheters remained patent one year after their implantation in hypertensive patients	one year
Secondary	one year patency rate of hemodialysis catheters in patients on antiplatelet drugs	percent of catheters remained patent one year after their implantation in patients on antiplatelet drugs	one year
Secondary	one year patency rate of hemodialysis catheters in sex subgroups	percent of catheters remained patent one year after their implantation in sex subgroups	one year