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

NCT ID: NCT06365489

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-11
• Study Completion Date: 2024-09-15

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

Conditions

Vascular Access Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golestan University of Medical sciences

OTHER

Sponsor Role: lead

Responsible Party

Pezhman Kharazm, MD

Vascular Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pezhman Kharazm, MD

Gorgan, Golestan Province, Iran

Countries

Iran

Other Identifiers

113293

Identifier Type: -

Identifier Source: org_study_id