跳至主要内容
临床试验/NCT02632942
NCT02632942Unknown不适用

Assessing Clinical Utility of the Criteria for Accessory Vein Obliteration for Failing Arteriovenous Fistula.

King Faisal Specialist Hospital & Research Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Maturation of AVF

研究概览

简要总结

Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe economic burden on any health care system. Native arteriovenous fistula (AVF) is the preferred form of permanent dialysis access since it is associated with the best long term outcome as compared to other forms of dialysis access. Despite the clinical benefits, many patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF rates is early fistula failure (EFF). The two most important causes for EFF amenable to intervention are stenosis anywhere in the circuit and/or presence of accessory vein (av). Although management of stenosis is well established with relatively clear guidelines, the management of av lacks clear scientific approach. In a recent study researchers recommended a hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein obliteration. The purpose of this controlled, blinded, prospective trial is to assess the clinical utility of the HAQ criteria as compared to current recommendations for av obliteration.

详细描述

Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe economic burden on any health care system. Native arteriovenous fistula (AVF) is the preferred form of permanent dialysis access since it is associated with the best long term outcome as compared to other forms of dialysis access. Despite the clinical benefits, many patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF rates is early fistula failure (EFF). EFF is defined as an AVF that never develops adequately for dialysis (failure to mature) or which fails within 3 months of starting dialysis. An adequate AVF for dialysis according to Dialysis Outcome Quality Initiative (DOQI) guidelines is the one which a) Has a flow of greater than 600ml/min, b) Has a diameter of 0.6cm or greater and c) Is approximately not deeper than 0.6cm from the skin surface. Between 23%-46% of newly constructed AVF have problems with early failure resulting in a dismal one year patency of 60-65%.

In order to devise a strategy to prevent EFF, one needs to understand the physiology of fistula maturation. Creation of an AVF leads to an immediate increase in flow through the vein due to the pressure gradient created. This increase in flow leads to increase wall shear stress which is defined mathematically by the formula 4ηQ/πr3, where η is blood viscosity, Q is blood flow and r is vessel radius. Shear stress thus is directly proportional to blood flow while inversely proportional to vessel diameter. After the creation of the AVF, the flow mediated increase in shear stress is mitigated by vessel dilatation through biological mediators. Consequently the shear stress is brought back to pre-anastomosis levels leading to vessel dilation. It seems that this positive remodeling of the vein leading to AVF maturation is dependent on increase in blood flow rather than the increase in pressure. Any pathology affecting the blood flow through the newly constructed AVF can thus lead to failure to mature.

The two most important causes for EFF amenable to intervention are stenosis anywhere in the circuit and/or presence of accessory veins. While stenosis development is pathological and accessory vein (av) presence is natural, both lead to decreased blood flow through the main AVF circuit, which may be responsible for failure to mature. Addressing these two entities in a timely fashion can lead to salvage of many AVF, which otherwise would have been abandoned. Although management of stenosis is well established with relatively clear guidelines, the management of av lacks clear scientific approach. It has been anecdotally recommended that any av with a diameter greater than 25% of the AVF diameter should be considered for ligation. It is also suggested that the significance of an av can be ascertained by assessing the flow of contrast through the av during an angiogram or by assessing the augmentation of AVF after manually occluding the av during the procedure. These current recommendations are very subjective and none have been adequately studied to date leading to considerable debate on the issue of when to obliterate an av. A scientific approach to obliteration of av is essential to avoid an unnecessary procedure, which may even be harmful. Also, obliterating a non-significant av and waiting for AVF to mature may cause a delay in making a definite decision for the patient. These patients may have other factors and not av as the cause of EFF. Conversely, not obliterating a significant av may also delay the use of AVF for dialysis by causing EFF. In a recent study researchers recommended a hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein obliteration written below:

  1. 60% or greater diameter of the main AVF
  2. 50% diameter of AVF with at least one more av>40% in diameter.
  3. 50% in diameter and divides into branches of same size.
  4. av likely to interfere with cannulation on physical examination.
  5. >30% in diameter and associated with stenosis at site of origin.

The HAQ criteria for av obliteration is based on computational flow dynamic (CFD) models of AVF created using 2 dimensional CFD software. This criteria has not been tested in clinical trials and its clinical utility has not been established to date. The purpose of this controlled, blinded, prospective trial is to assess the clinical utility of the HAQ criteria as compared to current recommendations for av obliteration.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • All adult patients with age> 18 years and referred to KFSHRC for EFF satisfying any of the following criteria and willing to participate by providing informed consent will be included in the study:
  • ESRD on dialysis with EFF at least 4 weeks post-surgery.
  • Chronic kidney disease patients who are approaching ESRD with EFF and will need and are willing to start HD as soon as AVF matures.

排除标准

  • Patients with AVF which is deeper than 0.8cm from the skin.
  • AVF which is tortuous and lacks adequate straight segment for cannulation with 2 needles.
  • Patients on anti-coagulation and those with bleeding or disorders.
  • Life expectancy less than 12 months.
  • Documented severe contrast allergy.
  • Inability to come for timely and adequate follow up.
  • Patients undergoing transplantation work up and expected to be transplanted within 6 months.

结局指标

主要结局

Maturation of AVF

时间窗: 3 months

Maturation of AVF defined as an AVF which is used for hemodialysis with a pump speed of at least 300ml/min for 3 consecutive treatments

次要结局

  • Secondary Patency(6 months)
  • Primary Patency(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naveed Ul Haq

Director of Dialysis Access & Interventional Nephrology Program

King Faisal Specialist Hospital & Research Center

研究点 (2)

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