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

April 4, 2024 updated by: Pezhman Kharazm, MD, Golestan University of Medical sciences

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Golestan
      • Gorgan, Golestan, Iran, Islamic Republic of, 4918936316
        • Golestan University of Medical Sciences, faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one year patency rate of hemodialysis catheters
Time Frame: one year
percent of catheters remained patent one year after their implantation
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one year patency rate of hemodialysis catheters in age subgroups
Time Frame: one year
percent of catheters remained patent one year after their implantation in age subgroups
one year
one year patency rate of hemodialysis catheters in diabetic patients
Time Frame: one year
percent of catheters remained patent one year after their implantation in diabetic patients
one year
one year patency rate of hemodialysis catheters in hypertensive patients
Time Frame: one year
percent of catheters remained patent one year after their implantation in hypertensive patients
one year
one year patency rate of hemodialysis catheters in patients on antiplatelet drugs
Time Frame: one year
percent of catheters remained patent one year after their implantation in patients on antiplatelet drugs
one year
one year patency rate of hemodialysis catheters in sex subgroups
Time Frame: one year
percent of catheters remained patent one year after their implantation in sex subgroups
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golestan University of Medical sciences

Investigators

  • Study Director: Pezhman Kharazm, MD, assistant professor of vascular surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2022

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 51-112334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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