Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)

• ClinicalTrials.gov Identifier: NCT01604473
• Recruitment Status: Unknown
• First Posted: May 23, 2012
• Last Update Posted: January 8, 2018
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Warren J. Gasper, MD, University of California, San Francisco

Study Description

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 Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

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

Investigators

• Principal Investigator: Warren J Gasper, M.D.; University of California, San Francisco

More Information

• Responsible Party: Warren J. Gasper, MD, Assistant Professor of Surgery, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01604473
• Other Study ID Numbers: 10-02538
• First Posted: May 23, 2012
• 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; CKD; ESRD; AV Fistula; Arterio-venous fistula; hemodialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula; Urologic Diseases; Renal Insufficiency; Pathological Conditions, Anatomical; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities