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

NCT06365489 | Completed

• 1 other identifier: 113293
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Early post operative WBI changes following AVF implantation

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

  one year

• Two-week post operative WBI changes following AVF implantation

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

  one year

• Three-month post operative WBI changes following AVF implantation

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

  one year

Secondary Outcomes (4)

• 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

• Correlation between WBI changes following AVF implantation with steal syndrome

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Golestan University of Medical sciences: lead

Study Sites (1)

Pezhman Kharazm, MD

Gorgan, Golestan Province, 4917956808, Iran

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular Surgeon

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: December 11, 2022
• Primary Completion: February 20, 2023
• Study Completion: September 15, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

IR (1)