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临床试验/NCT06355466
NCT06355466已完成不适用

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 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
1
主要终点
one year patency rate of hemodialysis catheters

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • ESRD on chronic hemodialysis Not eligible for AVF/AVG

排除标准

  • Non-consent of the patient Death Failure to follow up Opportunity for AVF/AVG implantation during the study Failure to implant trans-jugular catheter

结局指标

主要结局

one year patency rate of hemodialysis catheters

时间窗: one year

percent of catheters remained patent one year after their implantation

次要结局

  • 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)

研究者

发起方
Golestan University of Medical sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pezhman Kharazm, MD

Vascular Surgeon

Golestan University of Medical sciences

研究点 (1)

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