Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604473
Recruitment Status : Active, not recruiting
First Posted : May 23, 2012
Last Update Posted : January 8, 2018
Information provided by (Responsible Party):
Warren J. Gasper, MD, University of California, San Francisco

May 21, 2012
May 23, 2012
January 8, 2018
October 2010
October 2018   (Final data collection date for primary outcome measure)
Maturation of Arteriovenous Fistula [ Time Frame: 90 days ]
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.
Same as current
Complete list of historical versions of study NCT01604473 on Archive Site
  • Primary Patency [ Time Frame: 90 days ]
    Primary patency of the AV fistula
  • Secondary Patency [ Time Frame: 90 days ]
    Secondary patency of the AV fistula
  • Stenosis of AV fistula [ Time Frame: 90 days ]
    Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram
  • Venous remodeling [ Time Frame: 90 days ]
    Venous remodeling at 3 months
  • Arterial remodeling [ Time Frame: 90 days ]
    Arterial remodeling at 3 months
Same as current
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Endothelial Function and Arterio-Venous Fistula Maturation
Endothelial Function and Arterio-Venous Fistula Maturation
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.

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.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Vascular surgery clinic
Chronic Kidney Disease
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Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
October 2019
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Warren J. Gasper, MD, University of California, San Francisco
University of California, San Francisco
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Principal Investigator: Warren J Gasper, M.D. University of California, San Francisco
University of California, San Francisco
January 2018