Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

Tracking Information
First Submitted Date	February 3, 2009
First Posted Date	February 4, 2009
Last Update Posted Date	February 5, 2018
Actual Study Start Date	January 10, 2009
Actual Primary Completion Date	December 13, 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 3, 2009)	50% increase in upper arm vein diameter [ Time Frame: Six months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00836563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Vascular Changes Following Forearm Loop Arteriovenous Graft Placement
Official Title	The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous
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
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients undergoing forearm arteriovenous loop graft placement
Condition	Chronic Kidney Disease
Intervention	Not Provided
Study Groups/Cohorts	Forearm Arteriovenous Loop Graft
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: February 1, 2018)	10
Original Estimated Enrollment; (submitted: February 3, 2009)	12
Actual Study Completion Date	December 13, 2011
Actual Primary Completion Date	December 13, 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Age greater than or equal to 19 years; Planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days.; 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: Age less than 19 years; Hemodialysis access other than forearm loop graft surgery placement; Cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla; Prior hemodialysis access surgery in the arm receiving the forearm loop graft
Sex/Gender	Sexes Eligible for Study: All
Ages	19 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00836563
Other Study ID Numbers	444-08-FB
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Troy Plumb, MD, University of Nebraska
Study Sponsor	University of Nebraska
Collaborators	Not Provided
Investigators	Principal Investigator: Troy J Plumb, MD University of Nebraska
PRS Account	University of Nebraska
Verification Date	February 2018