Clinical trial NCT01604473: Endothelial Function and Arterio-Venous Fistula Maturation
Official title: Endothelial Function and Arterio-Venous Fistula Maturation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
CKD
ESRD
AV Fistula
Arterio-venous fistula
hemodialysis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vascular surgery clinic

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maturation of Arteriovenous Fistula
timeFrame: 90 days
Secondary outcomes:
measure: Primary Patency
timeFrame: 90 days
measure: Secondary Patency
timeFrame: 90 days
measure: Stenosis of AV fistula
timeFrame: 90 days
measure: Venous remodeling
timeFrame: 90 days
measure: Arterial remodeling
timeFrame: 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Warren J Gasper, M.D.
role: PRINCIPAL_INVESTIGATOR
References: