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Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by University of Nebraska.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836563
First Posted: February 4, 2009
Last Update Posted: July 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Nebraska
  Purpose
The purpose of this study is to determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement, and if they do, characterize the timing of these changes

Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 50% increase in upper arm vein diameter [ Time Frame: Six months ]

Estimated Enrollment: 12
Study Start Date: January 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Forearm Arteriovenous Loop Graft

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing forearm arteriovenous loop graft placement
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 19 years
  2. Planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days.
  3. Cephalic and/or basilic vein diameter greater than or equal to 2.5 mm at the antecubital fossa to the axilla prior to AVG placement

Exclusion Criteria:

  1. Age less than 19 years
  2. Hemodialysis access other than forearm loop graft surgery placement
  3. Cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla
  4. Prior hemodialysis access surgery in the arm receiving the forearm loop graft
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836563


Contacts
Contact: LuAnn Larson, RN, BSN 402-559-8555 llarson@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center/The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: LuAnn Larson, RN, BSN    402-559-8555    llarson@unmc.edu   
Principal Investigator: Troy J Plumb, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Troy J Plumb, MD University of Nebraska
  More Information

Responsible Party: Troy J. Plumb, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00836563     History of Changes
Other Study ID Numbers: 444-08-FB
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: July 16, 2010
Last Verified: July 2010

Keywords provided by University of Nebraska:
Hemodialysis
Arteriovenous Graft

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency