Hemodialysis in the Elderly (70yrs & Older)

Launched by E. PEDEN, MD · Feb 22, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of creating access points for hemodialysis in elderly patients aged 70 and older who have severe kidney disease. Specifically, it compares the use of an autologous arteriovenous fistula, which is a connection made using the patient’s own blood vessels, to a hemodialysis access graft, which involves using a synthetic tube. The trial aims to enroll 270 patients over five years to see which method is more effective for patients needing dialysis.

To qualify for the trial, participants must be at least 70 years old and have specific vascular conditions that allow for the creation of a fistula. They should also be diagnosed with end-stage renal disease, meaning their kidneys are functioning very poorly. Those who are already on hemodialysis but have had trouble with their previous access points, or who are expected to start dialysis soon, may also be eligible. Participants can expect close monitoring and follow-up during the study, helping researchers to understand which method works best for elderly patients. It's important to note that certain health conditions, such as bleeding disorders or active infections, may prevent someone from joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥70 years of all ethnicities, and;
• • Have vascular anatomy amenable to arteriovenous fistula creation, and;
• • Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR \<15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
• • Currently undergoing hemodialysis with a failure of previous access; or,
• • Expected to undergo hemodialysis within 6 months of presentation.
• Exclusion Criteria:
• • Unable or refuse to abide with follow-up; or,
• • Known hypercoagulability syndrome or a bleeding disorder; or,
• • Intraoperative decision was made in favor of fistula instead of graft; or,
• • Active infections; or,
• • Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 months.