NCT06355466

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

December 23, 2023

Last Update Submit

April 4, 2024

Conditions

Vascular Access Devices

Keywords

HemodialysisTunneled catheterPatencyAntiplatelet

Outcome Measures

Primary Outcomes (1)

  • one year patency rate of hemodialysis catheters

    percent of catheters remained patent one year after their implantation

    one year

Secondary Outcomes (5)

  • one year patency rate of hemodialysis catheters in age subgroups

    one year

  • one year patency rate of hemodialysis catheters in diabetic patients

    one year

  • one year patency rate of hemodialysis catheters in hypertensive patients

    one year

  • one year patency rate of hemodialysis catheters in patients on antiplatelet drugs

    one year

  • one year patency rate of hemodialysis catheters in sex subgroups

    one year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • ESRD on chronic hemodialysis Not eligible for AVF/AVG

You may not qualify if:

  • Non-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golestan University of Medical Sciences, faculty of medicine

Gorgan, Golestan Province, 4918936316, Iran

Location

Related Publications (22)

  • 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: 33752206RESULT

  • 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: 33652433RESULT

  • 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: 35210738RESULT

  • 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: 32891307RESULT

  • 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: 12745728RESULT

  • 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: 36251438RESULT

  • 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: 30876612RESULT

  • 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: 37311842RESULT

  • 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: 21115628RESULT

  • 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: 31704426RESULT

  • 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: 30421638RESULT

  • 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: 33016167RESULT

  • 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: 25198820RESULT

  • 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: 28135701RESULT

  • 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: 23871694RESULT

  • 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: 30010473RESULT

  • 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: 23022428RESULT

  • 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: 29804743RESULT

  • 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: 23841041RESULT

  • 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: 17890252RESULT

  • 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: 23891045RESULT

  • 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.

    PMID: 11325679RESULT

Study Officials

  • Pezhman Kharazm, MD

    assistant professor of vascular surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular Surgeon

Study Record Dates

First Submitted

December 23, 2023

First Posted

April 9, 2024

Study Start

January 9, 2022

Primary Completion

August 11, 2023

Study Completion

August 28, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

IR(1)