Comparing two types of vascular access for hemodialysis in elderly patients
A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients
NA · The Methodist Hospital Research Institute · NCT03065972
This study is testing whether a natural blood vessel connection or a graft works better for hemodialysis in patients aged 70 and older.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03065972 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, single institution, randomized-controlled trial that aims to compare the effectiveness of autologous arteriovenous fistula versus hemodialysis access grafts in patients aged 70 years and older. A total of 270 patients will be enrolled over a period of 5 years, with follow-up conducted for 2 years after access creation. Patients will be randomly assigned to one of the two intervention groups using a concealed block randomization method, and both patients and research staff will be blinded to group assignments to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 70 years and older with end-stage renal disease requiring vascular access for hemodialysis.
Not a fit: Patients with known bleeding disorders, active infections, or those who cannot comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the most effective vascular access method for elderly patients undergoing hemodialysis, potentially improving their treatment outcomes.
How similar studies have performed: Other studies have explored vascular access methods in hemodialysis, but this specific comparison in the elderly population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Eric K Peden, MD — The Methodist Hospital Research Institute
- Study coordinator: Bright Benfor, MD
- Email: bbenfor@houstonmethodist.org
- Phone: 713-441-0147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Disease, Kidney Failure, Chronic Kidney Disease, kidney disease, vascular access, graft, fistula, hemodialysis