Clinical trial NCT02374762: Hemodialysis Vascular Access Imaging Study
Official title: Contact-Free Video Imaging of Arteriovenous Fistulas In Chronic Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Fistula
Hemodialysis Fistula Thrombosis
Keywords: Arteriovenous Fistula
Hemodialysis
Vascular Access
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators would like to study patients with chronic kidney disease, currently undergoing hemodialysis via AVF at Renal Research Institute dialysis clinics.

Brief summary: The goal of this study is to find the best techniques to take non-invasive images of the arteriovenous fistula (AVF) in hemodialysis patients.

Detailed description: The vascular access is at the same time both the 'lifeline' and the 'Achilles' heel' of hemodialysis patients. Despite improved understanding of the pathophysiology of stenosis and thrombosis of the vascular access, unfortunately translating these advances into either improved therapies or a superior process of care has not been very successful. As a result, there continues to be an epidemic of arteriovenous fistula (AVF) maturation failure, a proliferation of relatively ineffective interventions such as angioplasty and stent placement, an extremely high incidence of catheter use (1).

A major problem is the timely diagnosis of AVF access dysfunction, which - undiagnosed and untreated - will eventually result in its loss. Current methods of diagnosing impending AVF deterioration utilize measurement of access flow, access flow recirculation, ultrasound imaging and angiography. None of these methods are applicable on a per-treatment basis and require some sort of intervention.

Recent advances in video-imaging open the opportunity to non-invasively track AVF movements, possibly on a routine basis. These AVF movements are created by the arterial pulse and routinely checked manually prior to each AVF cannulation. In this research the investigators plan to film the actual AVF movements with the goal to explore the technical feasibility of video-imaging based access surveillance.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years; routinely cannulated AVF in place

Exclusion Criteria:

* inability to communicate in English
* skin maladies which render meaningful AVF imaging impossible
* vascular access procedures in the last 8 weeks

Primary outcomes:
measure: Images of Arteriovenous fistula (AVF) Thrill
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riella MC, Roy-Chaudhury P. Vascular access in haemodialysis: strengthening the Achilles' heel. Nat Rev Nephrol. 2013 Jun;9(6):348-57. doi: 10.1038/nrneph.2013.76. Epub 2013 Apr 16.