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Clinical Trials/NCT06355466
NCT06355466
Completed
Not Applicable

Evaluation of Duration of the Long-term Hemodialysis Catheters Patency and Its Effecting Factors in Chronic Hemodialysis Patients in Golestan Province in 1400-1401

Golestan University of Medical sciences1 site in 1 country156 target enrollmentJanuary 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Access Devices
Sponsor
Golestan University of Medical sciences
Enrollment
156
Locations
1
Primary Endpoint
one year patency rate of hemodialysis catheters
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2022
End Date
August 28, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Golestan University of Medical sciences
Responsible Party
Principal Investigator
Principal Investigator

Pezhman Kharazm, MD

Vascular Surgeon

Golestan University of Medical sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

one year patency rate of hemodialysis catheters

Time Frame: one year

percent of catheters remained patent one year after their implantation

Secondary Outcomes

  • 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)

Study Sites (1)

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