Vascular Access DevicesNCT06355466
Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors
An observational study of Vascular Access Devices, run by Golestan University of Medical sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Access Devices
- How many people
- 156 participants
- Where
- 1 siteIran
- Study dates
- 9 Jan 2022to 28 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- ESRD on chronic hemodialysis Not eligible for AVF/AVG
Who cannot join
- Non-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter
Trial locations and contacts
1 site in 1 country.
Iran1 site
Golestan University of Medical Sciences, faculty of medicine
Gorgan, Golestan Province, 4918936316
About this study
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
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.
Read the detailed 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.
- Conditions
- Vascular Access Devices
- Keywords
- Hemodialysis, Tunneled catheter, Patency, Antiplatelet
What is being measured
The primary outcome is the main question the study is designed to answer.
one year patency rate of hemodialysis catheters
percent of catheters remained patent one year after their implantation
Measured: one year
Secondary outcomes (5)
one year patency rate of hemodialysis catheters in age subgroups
percent of catheters remained patent one year after their implantation in age subgroups
Measured: one year
one year patency rate of hemodialysis catheters in diabetic patients
percent of catheters remained patent one year after their implantation in diabetic patients
Measured: one year
one year patency rate of hemodialysis catheters in hypertensive patients
percent of catheters remained patent one year after their implantation in hypertensive patients
Measured: one year
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
Measured: one year
one year patency rate of hemodialysis catheters in sex subgroups
percent of catheters remained patent one year after their implantation in sex subgroups
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start9 Jan 2022
- Primary completion11 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pezhman Kharazm, MD, Golestan University of Medical sciences
- Investigators
- Pezhman Kharazm, MD, Study director, assistant professor of vascular surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355466
- Sponsor's protocol ID
- 51-112334
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33752206Ikizler 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.
PubMed 33652433El 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.
PubMed 35210738Boubes 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.
PubMed 32891307Obialo 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.
PubMed 12745728Yaxley 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.
PubMed 36251438Kumbar 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.
PubMed 30876612Braet 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.
PubMed 37311842Besarab 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.
PubMed 21115628Agha 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.
PubMed 31704426Coker 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.
PubMed 30421638Xiong 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.
PubMed 33016167Valliant 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.
PubMed 25198820Shi 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.
PubMed 28135701Shingarev 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.
PubMed 23871694
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06355466
- Acronym / sponsor ID
- 51-112334
- Conditions
- Vascular Access Devices
- Keywords
- Hemodialysis, Tunneled catheter, Patency, Antiplatelet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ESRD on chronic hemodialysis Not eligible for AVF/AVG
Key exclusion criteria (1 listed)
- Non-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
one year patency rate of hemodialysis catheters
Time frame: one year
percent of catheters remained patent one year after their implantation
5 secondary outcomes
one year patency rate of hemodialysis catheters in age subgroups
Time frame: one year
one year patency rate of hemodialysis catheters in diabetic patients
Time frame: one year
one year patency rate of hemodialysis catheters in hypertensive patients
Time frame: one year
one year patency rate of hemodialysis catheters in patients on antiplatelet drugs
Time frame: one year
one year patency rate of hemodialysis catheters in sex subgroups
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Results publication: PubMed 33752206Thurlow 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.
- Results publication: PubMed 33652433Ikizler 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.
- Results publication: PubMed 35210738El 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.
- Results publication: PubMed 32891307Boubes 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.
- Results publication: PubMed 12745728Obialo 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.
- Results publication: PubMed 36251438Yaxley 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.
- Results publication: PubMed 30876612Kumbar 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.
- Results publication: PubMed 37311842Braet 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.
- Results publication: PubMed 21115628Besarab 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.
- Results publication: PubMed 31704426Agha 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.
- Results publication: PubMed 30421638Coker 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.
- Results publication: PubMed 33016167Xiong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pezhman Kharazm, MD study director
assistant professor of vascular surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Devices, run by Golestan University of Medical sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year patency rate of hemodialysis catheters (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355466, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.