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

NCT ID: NCT00836862

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-01

Study Completion Date

2017-09-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Failure, Chronic

Keywords

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Hemodialysis Vascular access Arteriovenous fistula

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Arteriovenous Fistula

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.

Biologic specimens

Intervention Type OTHER

Banking of serum, DNA and tissue

Interventions

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Biologic specimens

Banking of serum, DNA and tissue

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Troy J Plumb, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0482-08-EP

Identifier Type: -

Identifier Source: org_study_id