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

Sponsor

E. Peden, MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03065972

Collaborator

The Methodist Hospital Research Institute (Other)

270

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Disease Kidney Failure Chronic Kidney Disease	Procedure: Surgical fistula creation from patient's anatomy Device: Surgical Graft implant	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgical fistula creation from patient's anatomy Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.	Procedure: Surgical 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. Other Names: Fistula
Active Comparator: Surgical graft implant Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.	Procedure: Surgical 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. Other Names: Fistula Device: Surgical 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. Other Names: FDA approved graft (various manufacturers)

Arm

Intervention/Treatment

Active Comparator: Surgical fistula creation from patient's anatomy

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

Procedure: Surgical 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.

Other Names:

Fistula

Active Comparator: Surgical graft implant

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

Procedure: Surgical 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.

Other Names:

Fistula

Device: Surgical 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.

Other Names:

FDA approved graft (various manufacturers)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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.