Hemodialysis in the Elderly (70yrs & Older) (ELDERLY)

E. Peden, MD

Status: Enrolling

Conditions: Chronic Kidney Disease; Kidney Failure; Kidney Disease

Treatments: Procedure: Surgical fistula creation from patient's anatomy; Device: Surgical Graft implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03065972

Pro00013220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Surgical fistula creation from patient's anatomy

Active Comparator group

Description:

Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.

Treatment:

Procedure: Surgical fistula creation from patient's anatomy

Surgical graft implant

Active Comparator group

Description:

Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.

Treatment:

Device: Surgical Graft implant

Procedure: Surgical fistula creation from patient's anatomy