Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Details

This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

Keywords

End-Stage Kidney Disease Hemodialysis Complication Hemodialysis central venous catheters arteriovenous fistula [AVF] arteriovenous graft [AVG] Arteriovenous Vascular Access Kidney Diseases Kidney Failure, Chronic AV graft surgical intervention for creation of a fistula fistula surgically placed graft surgically placed

Eligibility

You can join if…

Open to people ages 65 years and up

  • Age 65 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: coronary artery disease, peripheral arterial 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

You CAN'T join if...

  • 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.

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of Wisconsin School of Medicine and Public Health accepting new patients
    Madison Wisconsin 53726 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Wake Forest University Health Sciences
ID
NCT04646226
Study Type
Interventional
Participants
Expecting 262 study participants
Last Updated