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NCT00836862 Clinical Trial

Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens

Kidney Failure, Chronic Clinical Trial

Official title:
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00836862
Other study ID # 0482-08-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2009
Est. completion date September 7, 2017

Study information
Verified date December 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Description:

Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date September 7, 2017
Est. primary completion date November 10, 2012
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Age 19 years of age or greater - Arteriovenous fistula placement for hemodialysis access scheduled within 30 days Exclusion Criteria: - Incompetent to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Biologic specimens
Banking of serum, DNA and tissue

Locations
Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)
Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

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