Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01604473

10-02538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 1 patient group

Chronic Kidney Disease

Description:

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