Hemodialysis Vascular Access Imaging Study

Chronic Kidney Disease Clinical Trial

Official title:

Contact-Free Video Imaging of Arteriovenous Fistulas In Chronic Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374762
• Other study ID #: 15-051
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: February 22, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Chronic Kidney Disease
• Fistula
• Hemodialysis Fistula Thrombosis
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Renal Research Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Images of Arteriovenous fistula (AVF) Thrill	To determine if optimized video images can show the movements of the AVF pulse.	6 months	No