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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Diseases; Arteriovenous Fistula
• Intervention / Treatment: Diagnostic test: Hand acceleration time (HAT) measurement

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.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Begoña Gonzalo, MD; Phone Number: +34932607323; Email: bgonzalo@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Begoña Gonzalo, MD; Phone Number: +34932607323; Email: bgonzalo@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients candidate for AVF creation for hemodialysis in the Bellvitge University Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Candidates for AVF intervention; Patients requiring hemodialysis who are intervened for AVF creation.	Diagnostic test: Hand acceleration time (HAT) measurement; Hand Duplex Ultrasound to measure the Hand Acceleration Time (HAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean (standard deviation, SD) HAT measured with DUS.	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	24 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean (SD) fistula blood flow	Other sonographic parameters besides the HAT.	6 - 24 weeks
Mean (SD) vein diameter	Other sonographic parameters besides the HAT.	6 - 24 weeks
Morphology (description) of the distal radial artery spectral waveform.	Other sonographic parameters besides the HAT.	6 - 24 weeks
Mean (SD) anastomosis length	Other sonographic parameters besides the HAT.	6 - 24 weeks

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Begoña Gonzalo, MD, Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Vascular disease; Arteriovenous Fistula; Hand acceleration time; Hemodialysis access-induced distal ischemia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Vascular Diseases; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 2- VASC 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be made available from the principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No