Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Christopher Owens, MD, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01604473
First received: May 21, 2012
Last updated: August 15, 2014
Last verified: August 2014

May 21, 2012
August 15, 2014
October 2010
October 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01604473 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Vascular surgery clinic

Chronic Kidney Disease
Not Provided
Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2016
October 2015   (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
Both
18 Years to 90 Years
No
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
 
NCT01604473
10-02538
No
Christopher Owens, MD, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Christopher D Owens, M.D., M.Sc University of California, San Francisco
University of California, San Francisco
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP