Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors
- Conditions
- Vascular Access Devices
- Registration Number
- NCT06355466
- Lead Sponsor
- Golestan University of Medical sciences
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
ESRD on chronic hemodialysis Not eligible for AVF/AVG
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method one year patency rate of hemodialysis catheters one year percent of catheters remained patent one year after their implantation
- Secondary Outcome Measures
Name Time Method one year patency rate of hemodialysis catheters in age subgroups one year percent of catheters remained patent one year after their implantation in age subgroups
one year patency rate of hemodialysis catheters in diabetic patients one year percent of catheters remained patent one year after their implantation in diabetic patients
one year patency rate of hemodialysis catheters in hypertensive patients one year percent of catheters remained patent one year after their implantation in hypertensive patients
one year patency rate of hemodialysis catheters in patients on antiplatelet drugs one year percent of catheters remained patent one year after their implantation in patients on antiplatelet drugs
one year patency rate of hemodialysis catheters in sex subgroups one year percent of catheters remained patent one year after their implantation in sex subgroups
Trial Locations
- Locations (1)
Golestan University of Medical Sciences, faculty of medicine
🇮🇷Gorgan, Golestan, Iran, Islamic Republic of