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Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00836563
First received: February 3, 2009
Last updated: July 15, 2010
Last verified: July 2010
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 50% increase in upper arm vein diameter [ Time Frame: Six months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 3, 2009
Last Updated: July 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Hemodialysis
Arteriovenous Graft

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

ClinicalTrials.gov processed this record on May 23, 2013