Endothelial Function and Arterio-Venous Fistula Maturation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 1/10/2018 |
| Start Date: | October 2010 |
| End Date: | October 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
2
sites
San Francisco, California 94121
Principal Investigator: Warren J Gasper, M.D.
Phone: 415-221-4810
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
Principal Investigator: Warren Gasper, M.D.
Phone: 415-353-4367
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