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Completed

NCT Number: NCT06355466

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Golestan University of Medical Sciences, faculty of medicine

Gorgan, Golestan Province, 4918936316, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. one year patency rate of hemodialysis catheters

    Time frame: one year

    percent of catheters remained patent one year after their implantation

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Golestan University of Medical sciences

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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