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临床试验/NCT06365489
NCT06365489已完成不适用

Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery in Surgical Candidates Referred to Surgical Clinics in Gorgan in 1400

Golestan University of Medical sciences1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年12月11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
78
试验地点
1
主要终点
Three-month post operative WBI changes following AVF implantation

研究概览

简要总结

Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated.

详细描述

Chronic kidney disease (CKD) affects the structure and function of the kidneys. Many of CKD patients are not suitable candidates for a kidney transplant, so relying on some type of dyalisis is unavoidable.

Hemodialysis is the most common type of Renal Replacement Therapy. The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula (AVF). One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF.

Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF. Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal, it assures the surgeon that the distal circulation is sufficient.

Summary of the project implementation method: First, the demographic questionnaire is completed for patients who meet the criteria for entering the study. Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured. Two weeks and three months later (times of suture removal and fistula maturation assessment), the measurements are repeated and their correlations with steal syndrome symptoms are recorded.

The data will be analyzed in SPSS16 statistical software

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESRD patient candidate for hemodialysis
  • Eligible for AVF implantation
  • Cardiac Ejection Fraction > 20%
  • Age> 18 years
  • Suitable brachial artery and superficial vein for AVF

排除标准

  • Non-consent of the patient
  • Failure to follow up
  • Fistula failure

结局指标

主要结局

Three-month post operative WBI changes following AVF implantation

时间窗: one year

Comparison of wrist-brachial index before and three-month after implantation of AVF.

Two-week post operative WBI changes following AVF implantation

时间窗: one year

Comparison of wrist-brachial index before and two-week after implantation of AVF.

Early post operative WBI changes following AVF implantation

时间窗: one year

Comparison of wrist-brachial index before and after implantation of AVF in the operating room

次要结局

  • Correlation between WBI changes following AVF implantation with steal syndrome(one year)
  • Correlation between WBI changes following AVF implantation with age(one year)
  • Correlation between WBI changes following AVF implantation with sex(one year)
  • Correlation between WBI changes following AVF implantation with co-morbidities(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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