ACTIVE_NOT_RECRUITING

The Arteriovenous Vascular (AV) ACCESS Trial

Conditions

End-Stage Kidney Disease Hemodialysis Complication Hemodialysis central venous catheters arteriovenous fistula [AVF]arteriovenous graft [AVG]Arteriovenous Vascular Access

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Official Title

A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

Quick Facts

Study Start:2022-08-18

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04646226

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.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 60 years or older * End-stage kidney disease on hemodialysis via a central venous catheter * Hemodialysis is the long-term modality of treatment for end-stage kidney disease * Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation * Referred by patient's nephrologist for placement of arteriovenous access * At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus * Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers * Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon * Patient agreed to study participation and signed the informed consent	* Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device * Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization * Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices) * Anticipated kidney transplant within 12 months * Anticipated conversion to peritoneal dialysis within 12 months * Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months * Anticipated non-compliance with medical care based on physician judgment * A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Inclusion Criteria

Exclusion Criteria

* Age 60 years or older
* End-stage kidney disease on hemodialysis via a central venous catheter
* Hemodialysis is the long-term modality of treatment for end-stage kidney disease
* Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
* Referred by patient's nephrologist for placement of arteriovenous access
* At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
* Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
* Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
* Patient agreed to study participation and signed the informed consent

* Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
* Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
* Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
* Anticipated kidney transplant within 12 months
* Anticipated conversion to peritoneal dialysis within 12 months
* Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
* Anticipated non-compliance with medical care based on physician judgment
* A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Contacts and Locations

Principal Investigator

Mariana Murea, MD

PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Matthew P Goldman, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Michael Allon, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 35487

United States

UCLA

Los Angeles, California, 90095

United States

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205

United States

Atrium Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157

United States

Prisma Health Upstate

Greenville, South Carolina, 29601

United States

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, 37920

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53726

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Mariana Murea, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences
Matthew P Goldman, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences
Michael Allon, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Registration Dates

Study Start Date2022-08-18

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-08-18

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

Hemodialysis
End-Stage Kidney Disease
central venous catheters
arteriovenous fistula [AVF]
arteriovenous graft [AVG]
Arteriovenous Vascular Access

Additional Relevant MeSH Terms

End-Stage Kidney Disease
Hemodialysis Complication