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临床试验/NCT06187207
NCT06187207招募中不适用

Hand Acceleration Time (HAT) Assessment of the Hand's Arterial Perfusion Before and After Creating an Arteriovenous Fistula (AVF) for Dialysis: A Prospective Cohort Study

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
125
试验地点
1
主要终点
Mean (standard deviation, SD) HAT measured with DUS.

研究概览

简要总结

The main objectives of this observational study are to compare the results of the sonographic parameter hand acceleration time (HAT) measured before and after creating an arteriovenous fistula (AVF) for hemodialysis and assess if it is associated with the incidence of hemodialysis access-induced distal ischemia (HAIDI).

The secondary objectives are to study the incidence of HAIDI in patients intervened for the creation of an AVF in the last 6 months, study the AVF permeability at 6 months, and study the AVF-related complications at 6 months.

详细描述

As the name suggests, hemodialysis access-induced distal ischemia (HAIDI) is an ischemic syndrome affecting the hand in the context of vascular access for hemodialysis. It is caused by the inability of the arterial tree to accommodate and vasodilate after the creation of an arteriovenous fistula (AVF). Furthermore, upper limbs with previously asymptomatic or paucisymptomatic arterial stenoses may suffer from higher blood flow demand after AVF is performed, thus giving rise to ischemic symptoms.

HAIDI affects 5-10% of AVF patients with a brachial fistula and less than 1% of those with a radio-cephalic fistula. The clinical presentation consists of hand hypoperfusion symptoms, which can be classified into four degrees of severity, according to Fontaine's classification. Notably, it is most commonly a chronic entity, starting approximately one month after creating the AVF.

The diagnostic work-up is often based on non-specific clinical signs and symptoms, such as coldness, paleness, trophic lesions, and absent/weak distal pulses. Complementary non-invasive tests to measure hand perfusion include determining the baseline and post-AVF compression digital pressures, digital-brachial index (DBI), plethysmography, and digital oxygen saturation. Nonetheless, no consensus exists on their reference values to diagnose HAIDI, and the definitive diagnosis often requires performing invasive procedures (arteriography).

Performing a duplex ultrasound (DUS) may be useful and provide valuable information. In the context of HAIDI, it may help us assess the proximal arterial integrity, define whether it is a high or low-flow fistula, and establish the distal arterial waveform. One interesting DUS parameter is the acceleration time (AT), which measures the time elapsed (in milliseconds) from the beginning of the arterial Doppler waveform until its systolic peak. It allows for a real-time assessment of the arterial waveform morphology.

Some authors have successfully described the reliability of the AT for lower limb assessment (pedal acceleration time, PAT), while others have used it in other arterial territories (e.g., carotid, pulmonary, and coronary arteries and the aorta). Markedly, the hand acceleration time (HAT) has also been described very recently as a potential tool to assess cardiogenic shock, subclavian iatrogenic ischemic lesions, and HAIDI. In the context of HAIDI, it may help us assess the proximal arterial integrity, define whether it is a high or low-flow fistula, and establish the distal arterial waveform. Therefore, we hypothesized that HAT is a sensitive method for detecting HAIDI in patients with an AVF.

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

  • Adult patients (≥18 years of age)
  • Both sexes
  • Candidates for AVF creation for hemodialysis
  • Patients who sign the informed consent form

排除标准

  • Patients deemed unable by the investigators to understand or comply with study-related procedures
  • Patients who refuse to participate in the study

结局指标

主要结局

Mean (standard deviation, SD) HAT measured with DUS.

时间窗: 24 weeks

The HAT will be measured before the surgery for AVF creation, and at 6 and 24 weeks after the surgery in the following arteries: * Distal radial artery * Distal ulnar artery * Princeps pollicis artery * Index finger radial artery * First common palmar digital artery * Third common palmar digital artery

次要结局

  • Hemodialysis (Yes/No) at the screening visit.(Day 1)
  • Number (percentage) of patients with past medical history of interest.(Day 1)
  • Number (percentage) of male/female participants.(Day 1)
  • Mean (SD) age of the participants.(Day 1)
  • Allen test (Positive/Negative) throughout the study.(Day 1)
  • Number (percentage) of patients presenting cardiovascular risk factors of interest.(Day 1)
  • Anticoagulant or antiplatelet treatment (Yes/No) throughout the study.(24 weeks)
  • Number (percentage) arteries used for AVF creation.(24 weeks)
  • Number (percentage) of venous outflow.(24 weeks)
  • Number (percentage) of anastomosis types performed.(24 weeks)
  • End-stage kidney disease diagnosis (Yes/No) throughout the study.(24 weeks)
  • Number (percentage) of AVF types performed.(24 weeks)
  • Number (percentage) veins used for AVF creation.(24 weeks)
  • Presence (Yes/No) of distal pulses in the upper limb.(24 weeks)
  • Functional fistula (Yes/No)(24 weeks)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Begoña Gonzalo Villanueva

Expert Vascular Surgeon

Hospital Universitari de Bellvitge

研究点 (1)

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