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NCT Number: NCT06365489

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Death
  • Non-consent of the patient
  • Failure to follow up
  • Fistula failure

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Correlation between WBI changes following AVF implantation with age

    Time frame: one year

    Comparison of WBI changes following AVF implantation in age sub groups

  2. Correlation between WBI changes following AVF implantation with sex

    Time frame: one year

    Comparison of WBI changes following AVF implantation in sex sub groups

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

    Time frame: one year

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

  4. Correlation between WBI changes following AVF implantation with steal syndrome

    Time frame: one year

    comparison of WBI changes following AVF implantation between patients experiencing steal syndrome symptoms and Asymptomatic participants.

Sponsors and collaborators

Lead sponsor

Golestan University of Medical sciences

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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