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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

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.

Condition or disease
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
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function and Arterio-Venous Fistula Maturation
Study Start Date : October 2010
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Primary Patency [ Time Frame: 90 days ]
    Primary patency of the AV fistula

  2. Secondary Patency [ Time Frame: 90 days ]
    Secondary patency of the AV fistula

  3. Stenosis of AV fistula [ Time Frame: 90 days ]
    Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram

  4. Venous remodeling [ Time Frame: 90 days ]
    Venous remodeling at 3 months

  5. Arterial remodeling [ Time Frame: 90 days ]
    Arterial remodeling at 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Vascular surgery clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01604473

United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Warren J Gasper, M.D. University of California, San Francisco

Responsible Party: Warren J. Gasper, MD, Assistant Professor of Surgery, University of California, San Francisco Identifier: NCT01604473     History of Changes
Other Study ID Numbers: 10-02538
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Warren J. Gasper, MD, University of California, San Francisco:
Chronic Kidney Disease
AV Fistula
Arterio-venous fistula

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities