Clinical trial NCT06187207: Hand Acceleration Time (HAT) Assessment Before and After Creating an Arteriovenous Fistula (AVF)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arteriovenous Fistula
Vascular Diseases
Keywords: Hand acceleration time
Arteriovenous Fistula
Vascular disease
Hemodialysis access-induced distal ischemia
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients candidate for AVF creation for hemodialysis in the Bellvitge University Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean (standard deviation, SD) HAT measured with DUS.
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean (SD) age of the participants.
timeFrame: Day 1
measure: Number (percentage) of male/female participants.
timeFrame: Day 1
measure: Number (percentage) of patients presenting cardiovascular risk factors of interest.
timeFrame: Day 1
measure: Number (percentage) of patients with past medical history of interest.
timeFrame: Day 1
measure: Hemodialysis (Yes/No) at the screening visit.
timeFrame: Day 1
measure: End-stage kidney disease diagnosis (Yes/No) throughout the study.
timeFrame: 24 weeks
measure: Anticoagulant or antiplatelet treatment (Yes/No) throughout the study.
timeFrame: 24 weeks
measure: Presence (Yes/No) of distal pulses in the upper limb.
timeFrame: 24 weeks
measure: Allen test (Positive/Negative) throughout the study.
timeFrame: Day 1
measure: Number (percentage) of AVF types performed.
timeFrame: 24 weeks
measure: Number (percentage) veins used for AVF creation.
timeFrame: 24 weeks
measure: Number (percentage) arteries used for AVF creation.
timeFrame: 24 weeks
measure: Number (percentage) of anastomosis types performed.
timeFrame: 24 weeks
measure: Number (percentage) of venous outflow.
timeFrame: 24 weeks
measure: Functional fistula (Yes/No)
timeFrame: 24 weeks
Other outcomes:
measure: Mean (SD) fistula blood flow
timeFrame: 6 - 24 weeks
measure: Mean (SD) anastomosis length
timeFrame: 6 - 24 weeks
measure: Mean (SD) vein diameter
timeFrame: 6 - 24 weeks
measure: Morphology (description) of the distal radial artery spectral waveform.
timeFrame: 6 - 24 weeks
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Begoña Gonzalo, MD
role: PRINCIPAL_INVESTIGATOR
References: