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):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01604473
First received: May 21, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endothelial Function and Arterio-Venous Fistula Maturation

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
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)
Groups/Cohorts
Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Vascular surgery clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604473

Contacts
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

Locations
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.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Warren J Gasper, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01604473     History of Changes
Other Study ID Numbers: 10-02538
Study First Received: May 21, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of California, San Francisco:
Chronic Kidney Disease
CKD
ESRD
AV Fistula
Arterio-venous fistula
hemodialysis

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

ClinicalTrials.gov processed this record on September 18, 2014