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Clinical Trials/NCT06365489
NCT06365489
Completed
N/A

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

Golestan University of Medical sciences1 site in 1 country78 target enrollmentDecember 11, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vascular Access Complication
Sponsor
Golestan University of Medical sciences
Enrollment
78
Locations
1
Primary Endpoint
Three-month post operative WBI changes following AVF implantation
Status
Completed
Last Updated
last year

Overview

Brief 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.

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

Registry
clinicaltrials.gov
Start Date
December 11, 2022
End Date
September 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Golestan University of Medical sciences
Responsible Party
Principal Investigator
Principal Investigator

Pezhman Kharazm, MD

Vascular Surgeon

Golestan University of Medical sciences

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

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.

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

Secondary Outcomes

  • Correlation between WBI changes following AVF implantation with steal syndrome(one year)
  • Correlation between WBI changes following AVF implantation with age(one year)
  • Correlation between WBI changes following AVF implantation with sex(one year)
  • Correlation between WBI changes following AVF implantation with co-morbidities(one year)

Study Sites (1)

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