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Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

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ClinicalTrials.gov Identifier: NCT00836563
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Troy Plumb, MD, University of Nebraska

Brief Summary:
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 or disease
Chronic Kidney Disease

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous
Actual Study Start Date : January 10, 2009
Actual Primary Completion Date : December 13, 2011
Actual Study Completion Date : December 13, 2011

Group/Cohort
Forearm Arteriovenous Loop Graft



Primary Outcome Measures :
  1. 50% increase in upper arm vein diameter [ Time Frame: Six months ]


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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

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


Locations
United States, Nebraska
University of Nebraska Medical Center/The Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Troy J Plumb, MD University of Nebraska

Responsible Party: Troy Plumb, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00836563     History of Changes
Other Study ID Numbers: 444-08-FB
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Troy Plumb, MD, University of Nebraska:
Hemodialysis
Arteriovenous Graft

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