Chronic Kidney DiseaseEFAVFNCT01604473
Endothelial Function and Arterio-Venous Fistula Maturation
An observational study of Chronic Kidney Disease, run by University of California, San Francisco at 2 sites in United States.
Trial summary
An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to 29 Apr 2014
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vascular surgery clinic
Who may be able to join
- Chronic Kidney Disease classification Stage IV or V
- Adequate quality cephalic or basilic vein based on pre-operative assessment
- Able to provide written informed consent
- Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination
Who cannot join
- Age >90 or < 18 years
- Diagnosed hypercoaguble state
- Recent surgery or other major illness or infection within 6 weeks
- Use of immunosuppresive medication
- History or organ transplantation
- Pregnancy or plans to become pregnant
- Estimated life expectancy is less than 1 year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center
San Francisco, California, 94121
University of California, San Francisco Medical Center
San Francisco, California, 94143
About this study
An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.
Read the detailed description
Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature.
One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, CKD, ESRD, AV Fistula, Arterio-venous fistula, hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Arteriovenous Fistula
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 |
|---|---|---|
| Chronic Kidney Disease | Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maturation of Arteriovenous Fistula
Maturation is defined by either:
- Less than three months have elapsed since AVF creation and cannulation of the fistual with two 17 gauge needles and delivery of a minimum of 400 ml/min for the duration of dialysis
- Greater than three months have elapsed since AVF creation and the individual has not yet initiated hemodialysis and the vein diameter is 4 mm and the volumetric flow rate is 400 ml/min.
Measured: 90 days
Secondary outcomes (5)
Primary Patency
Primary patency of the AV fistula
Measured: 90 days
Secondary Patency
Secondary patency of the AV fistula
Measured: 90 days
Stenosis of AV fistula
Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram
Measured: 90 days
Venous remodeling
Venous remodeling at 3 months
Measured: 90 days
Arterial remodeling
Arterial remodeling at 3 months
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startOct 2010
- Primary completion29 Apr 2014
- Study completion29 Apr 2014
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Warren J Gasper, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604473
- Sponsor's protocol ID
- 10-02538
- Acronym
- EFAVF
- Status last verified
- Sep 2022
- First submitted
- 21 May 2012
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function and Arterio-Venous Fistula Maturation
- ClinicalTrials.gov ID
- NCT01604473
- Acronym / sponsor ID
- EFAVF / 10-02538
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, CKD, ESRD, AV Fistula, Arterio-venous fistula, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- 29 Apr 2014 (actual)
- Study completion
- 29 Apr 2014 (actual)
- First posted
- 23 May 2012 (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.
An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.
Detailed description
Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature.
One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | – | –Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vascular surgery clinic
Key inclusion criteria (4 listed)
- Chronic Kidney Disease classification Stage IV or V
- Adequate quality cephalic or basilic vein based on pre-operative assessment
- Able to provide written informed consent
- Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination
Key exclusion criteria (7 listed)
- Age >90 or < 18 years
- Diagnosed hypercoaguble state
- Recent surgery or other major illness or infection within 6 weeks
- Use of immunosuppresive medication
- History or organ transplantation
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
Maturation of Arteriovenous Fistula
Time frame: 90 days
Maturation is defined by either: * Less than three months have elapsed since AVF creation and cannulation of the fistual with two 17 gauge needles and delivery of a minimum of 400 ml/min for the duration of dialysis * Greater than three months have elapsed since AVF creation and the individual has not yet initiated hemodialysis and the vein diameter is 4 mm and the volumetric flow rate is 400 ml/min.
5 secondary outcomes
Primary Patency
Time frame: 90 days
Secondary Patency
Time frame: 90 days
Stenosis of AV fistula
Time frame: 90 days
Venous remodeling
Time frame: 90 days
Arterial remodeling
Time frame: 90 days
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 23 Sep 2022.
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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.
Warren J Gasper, M.D. principal investigator
University of California, San Francisco
2 sites 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 California, San Francisco at 2 sites 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 4 inclusion and 7 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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Maturation of Arteriovenous Fistula (time frame: 90 days). 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 23 Sep 2022.