Endothelial Function and Arterio-Venous Fistula Maturation (EFAVF)
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|ClinicalTrials.gov Identifier: NCT01604473|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2012
Last Update Posted : January 8, 2018
|Condition or disease|
|Chronic Kidney Disease|
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 Type :||Observational|
|Actual Enrollment :||54 participants|
|Official Title:||Endothelial Function and Arterio-Venous Fistula Maturation|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Chronic Kidney Disease
Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.
- 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.
- Primary Patency [ Time Frame: 90 days ]Primary patency of the AV fistula
- Secondary Patency [ Time Frame: 90 days ]Secondary patency of the AV fistula
- Stenosis of AV fistula [ Time Frame: 90 days ]Moderate or severe stenosos of AV fistual as detected by duplex ultrasound or fistulagram
- Venous remodeling [ Time Frame: 90 days ]Venous remodeling at 3 months
- Arterial remodeling [ Time Frame: 90 days ]Arterial remodeling at 3 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604473
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|University of California, San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Warren J Gasper, M.D.||University of California, San Francisco|