Vascular Access ComplicationNCT06365489
Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery
An observational study of Vascular Access Complication, run by Golestan University of Medical sciences at 1 site in Iran.
Trial summary
Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication
- How many people
- 78 participants
- Where
- 1 siteIran
- Study dates
- 11 Dec 2022to 15 Sep 2024
- 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: All ESRD patients who are candidates for AVF implantation after arterial and venous mapping, cardiac evaluation, and informed consent.
Who may be able to join
- ESRD patient candidate for hemodialysis
- Eligible for AVF implantation
- Cardiac Ejection Fraction > 20%
- Age> 18 years
- Suitable brachial artery and superficial vein for AVF
Who cannot join
- Death
- Non-consent of the patient
- Failure to follow up
- Fistula failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery in Surgical Candidates Referred to Surgical Clinics in Gorgan in 1400
Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated.
Read the detailed description
Chronic kidney disease (CKD) affects the structure and function of the kidneys. Many of CKD patients are not suitable candidates for a kidney transplant, so relying on some type of dyalisis is unavoidable.
Hemodialysis is the most common type of Renal Replacement Therapy. The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula (AVF). One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF.
Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF. Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal, it assures the surgeon that the distal circulation is sufficient.
Summary of the project implementation method: First, the demographic questionnaire is completed for patients who meet the criteria for entering the study. Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured. Two weeks and three months later (times of suture removal and fistula maturation assessment), the measurements are repeated and their correlations with steal syndrome symptoms are recorded.
The data will be analyzed in SPSS16 statistical software
- Conditions
- Vascular Access Complication
- Keywords
- Hemodialysis, Arterio Venous Fistula, Steal Syndrome, Wrist-Brachial Index, Vascular Access
- Medical subject headings
- Arteriovenous Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post operative WBI changes following AVF implantation
Comparison of wrist-brachial index before and after implantation of AVF in the operating room
Measured: one year
Two-week post operative WBI changes following AVF implantation
Comparison of wrist-brachial index before and two-week after implantation of AVF.
Measured: one year
Three-month post operative WBI changes following AVF implantation
Comparison of wrist-brachial index before and three-month after implantation of AVF.
Measured: one year
Secondary outcomes (4)
Correlation between WBI changes following AVF implantation with age
Comparison of WBI changes following AVF implantation in age sub groups
Measured: one year
Correlation between WBI changes following AVF implantation with sex
Comparison of WBI changes following AVF implantation in sex sub groups
Measured: one year
Correlation between WBI changes following AVF implantation with co-morbidities
Comparison of WBI changes following AVF implantation in co-morbidity sub groups
Measured: one year
Correlation between WBI changes following AVF implantation with steal syndrome
comparison of WBI changes following AVF implantation between patients experiencing steal syndrome symptoms and Asymptomatic participants.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Dec 2022
- Primary completion20 Feb 2023
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golestan University of Medical sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pezhman Kharazm, MD, Golestan University of Medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365489
- Sponsor's protocol ID
- 113293
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery in Surgical Candidates Referred to Surgical Clinics in Gorgan in 1400
- ClinicalTrials.gov ID
- NCT06365489
- Acronym / sponsor ID
- 113293
- Conditions
- Vascular Access Complication
- Keywords
- Hemodialysis, Arterio Venous Fistula, Steal Syndrome, Wrist-Brachial Index, Vascular Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Golestan University of Medical sciencesUniversity, hospital or other
- Study start
- 11 Dec 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 15 Apr 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.
Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated.
Detailed description
Chronic kidney disease (CKD) affects the structure and function of the kidneys. Many of CKD patients are not suitable candidates for a kidney transplant, so relying on some type of dyalisis is unavoidable.
Hemodialysis is the most common type of Renal Replacement Therapy. The best vascular access for hemodialysis in patients with chronic renal failure is Arterio-venous fistula (AVF). One of the complications of arterio-venous fistula is Steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through AVF.
Non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and Steal syndrome from a functional AVF. Wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal, it assures the surgeon that the distal circulation is sufficient.
Summary of the project implementation method: First, the demographic questionnaire is completed for patients who meet the criteria for entering the study. Then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured. Two weeks and three months later (times of suture removal and fistula maturation assessment), the measurements are repeated and their correlations with steal syndrome symptoms are recorded.
The data will be analyzed in SPSS16 statistical software
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ESRD patients who are candidates for AVF implantation after arterial and venous mapping, cardiac evaluation, and informed consent.
Key inclusion criteria (5 listed)
- ESRD patient candidate for hemodialysis
- Eligible for AVF implantation
- Cardiac Ejection Fraction > 20%
- Age> 18 years
- Suitable brachial artery and superficial vein for AVF
Key exclusion criteria (4 listed)
- Death
- Non-consent of the patient
- Failure to follow up
- Fistula failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early post operative WBI changes following AVF implantation
Time frame: one year
Comparison of wrist-brachial index before and after implantation of AVF in the operating room
Two-week post operative WBI changes following AVF implantation
Time frame: one year
Comparison of wrist-brachial index before and two-week after implantation of AVF.
Three-month post operative WBI changes following AVF implantation
Time frame: one year
Comparison of wrist-brachial index before and three-month after implantation of AVF.
4 secondary outcomes
Correlation between WBI changes following AVF implantation with age
Time frame: one year
Correlation between WBI changes following AVF implantation with sex
Time frame: one year
Correlation between WBI changes following AVF implantation with co-morbidities
Time frame: one year
Correlation between WBI changes following AVF implantation with steal syndrome
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vascular Access Complication, run by Golestan University of Medical sciences at 1 site in Iran.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 11 Mar 2025. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post operative WBI changes following AVF implantation (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.