Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • San Francisco VA Medical Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Vascular surgery clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic Kidney Disease; Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency	Primary patency of the AV fistula	90 days
Secondary Patency	Secondary patency of the AV fistula	90 days
Stenosis of AV fistula	Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram	90 days
Venous remodeling	Venous remodeling at 3 months	90 days
Arterial remodeling	Arterial remodeling at 3 months	90 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Warren J Gasper, M.D., University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 29, 2014
• Study Completion (Actual): April 29, 2014

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; CKD; ESRD; hemodialysis; AV Fistula; Arterio-venous fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 10-02538