Chronic Kidney Disease, Kidney Disease, Kidney Failure
Conditions
Keywords
kidney disease, vascular access, graft, fistula, hemodialysis, dialysis
Brief summary
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Detailed description
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study. Following the access creation the patients will be followed-up as per the standard and study protocol for a period of 2 years from the time of access creation. The investigators will use block randomization to achieve a patient allocation ratio of 1:1, using varying blocks of sizes 4 and 6 in a random order as per a web-based/computer generated system maintained as a block randomization sequence/list concealed from the blinded clinical and trial research team until the end of trial. Patients will be randomly allocated based on this permuted sequence to either of the two intervention groups. Masking will be performed and shall involve blinding of the patients participating in the trial. The research assistants involved with consenting, enrolling, data collection and follow-up, and the statistician analyzing the outcome measures will be blinded to the group assignment. The operating surgeon shall be blinded to the allocation process until the time of access creation following which the knowledge regarding the type of access creation by the surgeon is inevitable. All patients will be consented and their study related details including history, physical evaluations, diagnostic tests, etc., will be entered on a case report form and maintained on a web-based database. The patients will be followed-up for a period of 2 years from the time of initial access creation until the access is abandoned or rendered nonfunctional until the end of the study period.
Interventions
PROCEDURESurgical fistula creation from patient's anatomy
Patient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient's anatomy.
DEVICESurgical Graft implant
Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.
Sponsors
The Methodist Hospital Research Institute
E. Peden, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients. | 12 months | Assess frequency of HD access use, abandonment, and patency at 12 months post-procedure. We will communicate with the patient every month from date of surgery until 12 months to complete questionnaires to determine access use and patency for their study related access creation |
| Functional cumulative patency rate at 12 months | 12 months | Functional refers to the availability of the access for hemofiltration. Primary patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure | 2 years | Using Disease Outcomes Quality Initiative quality of life tool |
| To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes. | 2 years | Analysis of hospital bills to compare the costs with both types of hemodialysis interventions |
| Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure | 2 years | Using Disease Outcomes Quality Initiative quality of life tool |
| Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to patient's quality of life in the 2 years post fistula/graft procedure | 2 years | Using Disease Outcomes Quality Initiative quality of life tool |
Countries
United States
Contacts
Primary ContactBright Benfor, MD
Backup ContactBevin A Lopez, MS,CEP,CCRP
Outcome results
None listed