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:

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

Tracking Information

First Received Date ^ICMJE

February 3, 2009

Last Updated Date

July 15, 2010

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

50% increase in upper arm vein diameter [ Time Frame: Six months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00836563 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Chronic Kidney Disease

Intervention ^ICMJE

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 ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00836563

Other Study ID Numbers ^ICMJE

444-08-FB

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Troy J. Plumb, MD, University of Nebraska Medical Center

Study Sponsor ^ICMJE

University of Nebraska

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Troy J Plumb, MD

University of Nebraska

Information Provided By

University of Nebraska

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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