Clinical trial NCT03065972: Hemodialysis in the Elderly (70yrs & Older)
Official title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Disease
Kidney Failure
Chronic Kidney Disease
Keywords: kidney disease
vascular access
graft
fistula
hemodialysis
dialysis
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2017-02-28
Enrollment: 270
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.
timeFrame: 12 months
measure: Functional cumulative patency rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Eric K Peden, MD
role: PRINCIPAL_INVESTIGATOR
References: