Chronic Kidney DiseaseNCT00836563
Vascular Changes Following Forearm Loop Arteriovenous Graft Placement
An observational study of Chronic Kidney Disease, run by University of Nebraska at 1 site in United States.
Trial summary
This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2009to 13 Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing forearm arteriovenous loop graft placement
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center/The Nebraska Medical Center
Omaha, Nebraska, 68105
About this study
Official title: The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous
This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Hemodialysis, Arteriovenous Graft
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Forearm Arteriovenous Loop Graft | Participants with planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days will have the upper arm vessels assessed following forearm loop arteriovenous graft placement for size changes and timing of changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper arm vein diameter
50% increase in upper arm vein diameter
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study start10 Jan 2009
- Primary completion13 Dec 2011
- Study completion13 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy J Plumb, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836563
- Sponsor's protocol ID
- 0444-08-EP
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2009
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous
- ClinicalTrials.gov ID
- NCT00836563
- Acronym / sponsor ID
- 0444-08-EP
- Conditions
- Chronic Kidney Disease
- Keywords
- Hemodialysis, Arteriovenous Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 10 Jan 2009 (actual)
- Primary completion
- 13 Dec 2011 (actual)
- Study completion
- 13 Dec 2011 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Forearm Arteriovenous Loop Graft | – | –Participants with planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days will have the upper arm vessels assessed following forearm loop arteriovenous graft placement for size changes and timing of changes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing forearm arteriovenous loop graft placement
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper arm vein diameter
Time frame: Six months
50% increase in upper arm vein diameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troy J Plumb, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper arm vein diameter (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.