Hemodialysis Vascular Access Imaging Study

February 22, 2016 updated by: Renal Research Institute

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

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Renal Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hemodialysis Patients with AVF
Hemodialysis patients that use an arteriovenous fistula (AVF) to receive their dialysis treatments will be invited to have their AVF recorded by a digital camera for one minute prior to cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Images of Arteriovenous fistula (AVF) Thrill
Time Frame: 6 months
To determine if optimized video images can show the movements of the AVF pulse.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renal Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-051 (Wichita Medical Research and Education Foundation IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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