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Hand Acceleration Time (HAT) Assessment Before and After Creating an Arteriovenous Fistula (AVF)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06187207
Acronym
HATs-ACCVAS
Enrollment
125
Registered
2024-01-02
Start date
2023-06-30
Completion date
2025-02-28
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, Vascular Diseases

Keywords

Hand acceleration time, Arteriovenous Fistula, Vascular disease, Hemodialysis access-induced distal ischemia

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.

Interventions

DIAGNOSTIC_TESTHand acceleration time (HAT) measurement

Hand Duplex Ultrasound to measure the Hand Acceleration Time (HAT)

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Mean (standard deviation, SD) HAT measured with DUS.24 weeksThe 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

MeasureTime frameDescription
Anticoagulant or antiplatelet treatment (Yes/No) throughout the study.24 weeks
Number (percentage) arteries used for AVF creation.24 weeksArteries used for AVF creation can be: * Radial artery * Humeral artery
Number (percentage) of anastomosis types performed.24 weeksTypes of anastomosis can be: * End-to-side anastomosis * Side-to-side anastomosis
Number (percentage) of venous outflow.24 weeksTypes of venous outflow can be: * One anterograde vein * Two anterograde veins * One anterograde vein and 1 retrograde vein
Functional fistula (Yes/No)24 weeks
Mean (SD) age of the participants.Day 1
Number (percentage) of male/female participants.Day 1
Number (percentage) of patients presenting cardiovascular risk factors of interest.Day 1Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia.
Number (percentage) of patients with past medical history of interest.Day 1A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.
Hemodialysis (Yes/No) at the screening visit.Day 1
End-stage kidney disease diagnosis (Yes/No) throughout the study.24 weeks
Presence (Yes/No) of distal pulses in the upper limb.24 weeksThe presence or absence of distal pulses in the upper limb will be assessed in all study visits.
Allen test (Positive/Negative) throughout the study.Day 1
Number (percentage) of AVF types performed.24 weeksTypes of AVF are: * Native AVF of the wrist * Native AVF of the elbow * Prosthetic AVF
Number (percentage) veins used for AVF creation.24 weeksVeins 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 vein

Other

MeasureTime frameDescription
Mean (SD) vein diameter6 - 24 weeksOther sonographic parameters besides the HAT.
Morphology (description) of the distal radial artery spectral waveform.6 - 24 weeksOther sonographic parameters besides the HAT.
Mean (SD) fistula blood flow6 - 24 weeksOther sonographic parameters besides the HAT.
Mean (SD) anastomosis length6 - 24 weeksOther sonographic parameters besides the HAT.

Countries

Spain

Contacts

Primary ContactBegoña Gonzalo, MD
bgonzalo@bellvitgehospital.cat+34932607323

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026