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

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Other: Biologic specimens

• Registration Number: NCT00836862
• Lead Sponsor: University of Nebraska

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-02-01
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2012-11-10
• Study Completion: 2017-09-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arteriovenous Fistula	Biologic specimens	A tissue bank will be created to collect serum, whole blood, and vein specimens obtained from participants undergoing Arteriovenous Fistula (AVF) placement and revision. The planned specimen harvests will allow for both pre- and post-AVF placement specimens from both maturing and failing AVF.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States