Hemodialysis Access Surveillance Evaluation Study

Not Applicable

Completed

Brief Summary: The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).

Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.

Recruitment & Eligibility

Inclusion Criteria

Chronic hemodialysis patients undergoing dialysis therapy via an upper extremity arteriovenous access (arteriovenous fistula or an arteriovenous graft) will be enrolled to have monthly surveillance flow measurement using Transonic system or physical examination of the arteriovenous access by qualified person at least once a month for a period of 2 years.

Exclusion Criteria

Patients requiring surgical intervention on the arteriovenous access.
History of access thrombosis (one or more access thrombosis of the current arteriovenous access).
Patients with signs of access infection.
Patients with a malignancy.
Patients with life expectancy of less than six months.
Unable to understand the study.
Unable to sign the consent form.
Patients with psychiatric disorder.
Age less than 18 or greater than 80 years.
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners

Arm && Interventions

Group	Intervention	Description
Surveillance Group	Transonic	Monthly blood flow surveillance by ultrasound dilution technique and standard of care.

Primary Outcome Measures

Name	Time	Method
Hemodialysis Access Thrombosis Rate	Up to 24 months	Evaluate the reduction of hemodialysis access thrombosis rate

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Tunneled Hemodialysis Catheter	Up to 24 months
Tunneled Hemodialysis Catheter Rate	Up to 24 months	Evaluate the reduction of tunneled hemodialysis catheter rate
Number of Hemodialysis Access Angiogram and Angioplasty Procedures	Up to 24 months	Evaluate the reduction of hemodialysis access angiogram and angioplasty procedures
Number of Hemodialysis Access Thrombectomy Procedures	Up to 24 months	Evaluate the reduction of hemodialysis access thrombectomy procedures

Locations (3): Albany Medical College
🇺🇸
Albany, New York, United States
North America Research Institute
🇺🇸
Azusa, California, United States
University of Miami Miller School of Medicine
🇺🇸
Miami, Florida, United States