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CompletedNCT06365489Updated Mar 11, 2025

Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery

An observational study in Vascular Access Complication, sponsored by Golestan University of Medical sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Golestan University of Medical sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
18 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Vascular Access Complication

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Keywords

  • Hemodialysis
  • Arterio Venous Fistula
  • Steal Syndrome
  • Wrist-Brachial Index
  • Vascular Access
03

In context

Arteriovenous Fistula

247 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's enrollment of 78 is below the median of 100 across 70 observational studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Golestan University of Medical sciences is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All ESRD patients who are candidates for AVF implantation after arterial and venous mapping, cardiac evaluation, and informed consent.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ESRD patient candidate for hemodialysis
  • Eligible for AVF implantation
  • Cardiac > 20%
  • Age> 18 years
  • Suitable brachial artery and superficial vein for AVF

Exclusion criteria

Exclusion Criteria:

  • Death
  • Non-consent of the patient
  • Failure to follow up
  • Fistula failure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Early post operative WBI changes following AVF implantation

    Comparison of wrist-brachial index before and after implantation of AVF in the operating room

    Time frame: one year

  2. Two-week post operative WBI changes following AVF implantation

    Comparison of wrist-brachial index before and two-week after implantation of AVF.

    Time frame: one year

  3. Three-month post operative WBI changes following AVF implantation

    Comparison of wrist-brachial index before and three-month after implantation of AVF.

    Time frame: one year

Secondary outcomes

  1. Correlation between WBI changes following AVF implantation with age

    Comparison of WBI changes following AVF implantation in age sub groups

    Time frame: one year

  2. Correlation between WBI changes following AVF implantation with sex

    Comparison of WBI changes following AVF implantation in sex sub groups

    Time frame: one year

  3. Correlation between WBI changes following AVF implantation with co-morbidities

    Comparison of WBI changes following AVF implantation in co-morbidity sub groups

    Time frame: one year

  4. 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.

    Time frame: one year

07

Study locations

1 site
  • Pezhman Kharazm, MD
    Gorgan, Golestan 4917956808, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06365489
Lead sponsor
Golestan University of Medical sciences
Responsible party
Pezhman Kharazm, MD (Vascular Surgeon, Golestan University of Medical sciences) — Principal investigator
First posted
Apr 15, 2024
Start date
Dec 11, 2022
Primary completion
Feb 20, 2023
Completion
Sep 15, 2024
Last update
Mar 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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