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NCT Number: NCT01604473

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.

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Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

San Francisco VA Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: EFAVF

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 23, 2012
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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