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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
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.
Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGAnalyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.
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
Time frame: 12 months
Functional cumulative patency rate at 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
Time frame: 12 months
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
Using Disease Outcomes Quality Initiative quality of life tool
Time frame: 2 years
To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.
Analysis of hospital bills to compare the costs with both types of hemodialysis interventions
Time frame: 2 years
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
Using Disease Outcomes Quality Initiative quality of life tool
Time frame: 2 years
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
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Using Disease Outcomes Quality Initiative quality of life tool
Time frame: 2 years