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.
Chronic Kidney Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Endothelial Function and Arterio-Venous Fistula Maturation|
- Maturation of Arteriovenous Fistula [ Time Frame: 90 days ] [ Designated as safety issue: No ]
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.
- Primary Patency [ Time Frame: 90 days ] [ Designated as safety issue: No ]Primary patency of the AV fistula
- Secondary Patency [ Time Frame: 90 days ] [ Designated as safety issue: No ]Secondary patency of the AV fistula
- Stenosis of AV fistula [ Time Frame: 90 days ] [ Designated as safety issue: No ]Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram
- Venous remodeling [ Time Frame: 90 days ] [ Designated as safety issue: No ]Venous remodeling at 3 months
- Arterial remodeling [ Time Frame: 90 days ] [ Designated as safety issue: No ]Arterial remodeling at 3 months
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604473
|Contact: Hugh F Alley||415-221-4810 ext 4708||Hugh.Alley@ucsfmedctr.org|
|Contact: Christine Hall||415-221-4810 ext 2115||Christine.Hall@ucsfmedctr.org|
|United States, California|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Hugh Alley 415-221-4810 ext 4708 Hugh.Alley@ucsfmedctr.org|
|Contact: Christine Hall (415) 221-4810 ext 2115 Christine.Hall@ucsfmedtr.org|
|Principal Investigator: Christopher D Owens, M.D., M.Sc|
|University of California, San Francisco Medical Center||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Julia Sobel, M.D. 415-353-4379 Julia.Soberl@ucsfmedctr.org|
|Principal Investigator: Warren Gasper, M.D.|
|Principal Investigator:||Warren J Gasper, MD||University of California, San Francisco|