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

Vascular Access Complication Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06365489
• Other study ID #: 113293
• Status: Active, not recruiting
• Start date: December 11, 2022
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Golestan University of Medical sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: September 2024
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Vascular Access Complication

Locations

Country	Name	City	State
Iran, Islamic Republic of	Pezhman Kharazm, MD	Gorgan	Golestan

Sponsors (1)

Lead Sponsor	Collaborator
Golestan University of Medical sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Two-week post operative WBI changes following AVF implantation	Comparison of wrist-brachial index before and two-week after implantation of AVF.	one year
Primary	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	Correlation between WBI changes following AVF implantation with age	Comparison of WBI changes following AVF implantation in age sub groups	one year
Secondary	Correlation between WBI changes following AVF implantation with sex	Comparison of WBI changes following AVF implantation in sex sub groups	one year
Secondary	Correlation between WBI changes following AVF implantation with co-morbidities	Comparison of WBI changes following AVF implantation in co-morbidity sub groups	one year
Secondary	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.	one year