Endothelial Function and Arterio-Venous Fistula Maturation

Chronic Kidney Disease Clinical Trial

— EFAVF  

Official title:

Endothelial Function and Arterio-Venous Fistula Maturation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604473
• Other study ID #: 10-02538
• Status: Completed
• Start date: October 2010
• Est. completion date: April 29, 2014

Study information

• Verified date: September 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.

Description:

Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature.

One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 29, 2014
• Est. primary completion date: April 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Chronic Kidney Disease classification Stage IV or V

• Adequate quality cephalic or basilic vein based on pre-operative assessment

• Able to provide written informed consent

• Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination

Exclusion Criteria:

• Age >90 or < 18 years

• Diagnosed hypercoaguble state

• Recent surgery or other major illness or infection within 6 weeks

• Use of immunosuppresive medication

• History or organ transplantation

• Pregnancy or plans to become pregnant

• Estimated life expectancy is less than 1 year

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Fistula
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of California, San Francisco Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maturation of Arteriovenous Fistula	Maturation is defined by either: Less than three months have elapsed since AVF creation and cannulation of the fistual with two 17 gauge needles and delivery of a minimum of 400 ml/min for the duration of dialysis; Greater than three months have elapsed since AVF creation and the individual has not yet initiated hemodialysis and the vein diameter is 4 mm and the volumetric flow rate is 400 ml/min.	90 days
Secondary	Primary Patency	Primary patency of the AV fistula	90 days
Secondary	Secondary Patency	Secondary patency of the AV fistula	90 days
Secondary	Stenosis of AV fistula	Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram	90 days
Secondary	Venous remodeling	Venous remodeling at 3 months	90 days
Secondary	Arterial remodeling	Arterial remodeling at 3 months	90 days