Arteriovenous FistulaHATs-ACCVASNCT06187207
Hand Acceleration Time (HAT) Assessment Before and After Creating an Arteriovenous Fistula (AVF)
An observational study of Arteriovenous Fistula and Vascular Diseases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Vascular Diseases
- What is being tested?
- Hand acceleration time (HAT) measurement
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients candidate for AVF creation for hemodialysis in the Bellvitge University Hospital.
Who may be able to join
- Adult patients (≥18 years of age)
- Both sexes
- Candidates for AVF creation for hemodialysis
- Patients who sign the informed consent form
Who cannot join
- Patients deemed unable by the investigators to understand or comply with study-related procedures
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Begoña Gonzalo, MD, +34932607323, bgonzalo@bellvitgehospital.cat
About this study
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
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.
Read the 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.
- Conditions
- Arteriovenous Fistula, Vascular Diseases
- Being tested
- Hand acceleration time (HAT) measurement
- Keywords
- Hand acceleration time, Arteriovenous Fistula, Vascular disease, Hemodialysis access-induced distal ischemia
- Medical subject headings
- Arteriovenous Fistula, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand acceleration time (HAT) measurementDiagnostic test
Hand Duplex Ultrasound to measure the Hand Acceleration Time (HAT)
| Study group | Role | What they receive |
|---|---|---|
| Candidates for AVF intervention | Patients requiring hemodialysis who are intervened for AVF creation. Receives: Diagnostic Test: Hand acceleration time (HAT) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (15)
Mean (SD) age of the participants.
Measured: Day 1
Number (percentage) of male/female participants.
Measured: 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.
Measured: 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.
Measured: Day 1
Hemodialysis (Yes/No) at the screening visit.
Measured: Day 1
End-stage kidney disease diagnosis (Yes/No) throughout the study.
Measured: 24 weeks
Anticoagulant or antiplatelet treatment (Yes/No) throughout the study.
Measured: 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.
Measured: 24 weeks
Allen test (Positive/Negative) throughout the study.
Measured: Day 1
Number (percentage) of AVF types performed.
Types of AVF are:
- Native AVF of the wrist
- Native AVF of the elbow
- Prosthetic AVF
Measured: 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
Measured: 24 weeks
Number (percentage) arteries used for AVF creation.
Arteries used for AVF creation can be:
- Radial artery
- Humeral artery
Measured: 24 weeks
Number (percentage) of anastomosis types performed.
Types of anastomosis can be:
- End-to-side anastomosis
- Side-to-side anastomosis
Measured: 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
Measured: 24 weeks
Functional fistula (Yes/No)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start30 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begoña Gonzalo Villanueva, Hospital Universitari de Bellvitge
- Investigators
- Begoña Gonzalo, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187207
- Sponsor's protocol ID
- 2- VASC 2023
- Acronym
- HATs-ACCVAS
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available from the principal investigator upon reasonable request.
Publications
Gonzalo B, Videla S, Espinar E, Palacios S, Herranz C, Iborra Ortega E. Hand acceleration time (HAT) as a diagnostic tool in the assessment of haemodialysis access-induced distal ischaemia (HAIDI): study protocol for a prospective cohort study in the Barcelona south metropolitan area. BMJ Open. 2025 Jan 2;15(1):e093911. doi: 10.1136/bmjopen-2024-093911.
PubMed 39753269
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06187207
- Acronym / sponsor ID
- HATs-ACCVAS / 2- VASC 2023
- Conditions
- Arteriovenous Fistula, Vascular Diseases
- Keywords
- Hand acceleration time, Arteriovenous Fistula, Vascular disease, Hemodialysis access-induced distal ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidates for AVF intervention | – | Diagnostic Test: Hand acceleration time (HAT) measurementPatients requiring hemodialysis who are intervened for AVF creation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients candidate for AVF creation for hemodialysis in the Bellvitge University Hospital.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years of age)
- Both sexes
- Candidates for AVF creation for hemodialysis
- Patients who sign the informed consent form
Key exclusion criteria (2 listed)
- Patients deemed unable by the investigators to understand or comply with study-related procedures
- Patients who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand acceleration time (HAT) measurementHand Duplex Ultrasound to measure the Hand Acceleration Time (HAT) | Diagnostic test | Candidates for AVF intervention |
Primary outcome
Mean (standard deviation, SD) HAT measured with DUS.
Time frame: 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
15 secondary outcomes
Mean (SD) age of the participants.
Time frame: Day 1
Number (percentage) of male/female participants.
Time frame: Day 1
Number (percentage) of patients presenting cardiovascular risk factors of interest.
Time frame: Day 1
Number (percentage) of patients with past medical history of interest.
Time frame: Day 1
Hemodialysis (Yes/No) at the screening visit.
Time frame: Day 1
End-stage kidney disease diagnosis (Yes/No) throughout the study.
Time frame: 24 weeks
Anticoagulant or antiplatelet treatment (Yes/No) throughout the study.
Time frame: 24 weeks
Presence (Yes/No) of distal pulses in the upper limb.
Time frame: 24 weeks
Allen test (Positive/Negative) throughout the study.
Time frame: Day 1
Number (percentage) of AVF types performed.
Time frame: 24 weeks
Number (percentage) veins used for AVF creation.
Time frame: 24 weeks
Number (percentage) arteries used for AVF creation.
Time frame: 24 weeks
Number (percentage) of anastomosis types performed.
Time frame: 24 weeks
Number (percentage) of venous outflow.
Time frame: 24 weeks
Functional fistula (Yes/No)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 39753269Gonzalo B, Videla S, Espinar E, Palacios S, Herranz C, Iborra Ortega E. Hand acceleration time (HAT) as a diagnostic tool in the assessment of haemodialysis access-induced distal ischaemia (HAIDI): study protocol for a prospective cohort study in the Barcelona south metropolitan area. BMJ Open. 2025 Jan 2;15(1):e093911. doi: 10.1136/bmjopen-2024-093911.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Begoña Gonzalo, MD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Vascular Diseases, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begoña Gonzalo, MD (+34932607323, bgonzalo@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean (standard deviation, SD) HAT measured with DUS. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.