Endothelial Function and Arterio-Venous Fistula Maturation
EFAVF
1 other identifier
observational
54
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2010
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2014
CompletedSeptember 23, 2022
September 1, 2022
3.6 years
May 21, 2012
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maturation of Arteriovenous Fistula
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.
90 days
Secondary Outcomes (5)
Primary Patency
90 days
Secondary Patency
90 days
Stenosis of AV fistula
90 days
Venous remodeling
90 days
Arterial remodeling
90 days
Study Arms (1)
Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.
Eligibility Criteria
Vascular surgery clinic
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Francisco VA Medical Center
San Francisco, California, 94121, United States
University of California, San Francisco Medical Center
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren J Gasper, M.D.
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
October 1, 2010
Primary Completion
April 29, 2014
Study Completion
April 29, 2014
Last Updated
September 23, 2022
Record last verified: 2022-09