Hand Acceleration Time (HAT) Assessment Before and After Creating an Arteriovenous Fistula (AVF)
- Conditions
- Vascular DiseasesArteriovenous Fistula
- Interventions
- Diagnostic Test: Hand acceleration time (HAT) measurement
- Registration Number
- NCT06187207
- Lead Sponsor
- Hospital Universitari de Bellvitge
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Adult patients (≥18 years of age)
- Both sexes
- Candidates for AVF creation for hemodialysis
- Patients who sign the informed consent form
- Patients deemed unable by the investigators to understand or comply with study-related procedures
- Patients who refuse to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Candidates for AVF intervention Hand acceleration time (HAT) measurement Patients requiring hemodialysis who are intervened for AVF creation.
- Primary Outcome Measures
Name Time Method Mean (standard deviation, SD) HAT measured with DUS. 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
- Secondary Outcome Measures
Name Time Method Hemodialysis (Yes/No) at the screening visit. Day 1 Number (percentage) of patients with past medical history of interest. Day 1 A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.
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 Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia.
Anticoagulant or antiplatelet treatment (Yes/No) throughout the study. 24 weeks Number (percentage) arteries used for AVF creation. 24 weeks Arteries used for AVF creation can be:
* Radial artery
* Humeral arteryNumber (percentage) of venous outflow. 24 weeks Types of venous outflow can be:
* One anterograde vein
* Two anterograde veins
* One anterograde vein and 1 retrograde veinEnd-stage kidney disease diagnosis (Yes/No) throughout the study. 24 weeks Number (percentage) of anastomosis types performed. 24 weeks Types of anastomosis can be:
* End-to-side anastomosis
* Side-to-side anastomosisNumber (percentage) of AVF types performed. 24 weeks Types of AVF are:
* Native AVF of the wrist
* Native AVF of the elbow
* Prosthetic AVFNumber (percentage) veins used for AVF creation. 24 weeks Veins used for AVF creation can be:
* Distal cephalic vein
* Cephalic vein at the elbow level
* Basilic vein at the elbow level
* Perforating vein of the elbow
* Axillary veinPresence (Yes/No) of distal pulses in the upper limb. 24 weeks The presence or absence of distal pulses in the upper limb will be assessed in all study visits.
Functional fistula (Yes/No) 24 weeks
Trial Locations
- Locations (1)
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain