Hemodialysis in the Elderly (70yrs & Older)

NCT ID: NCT03065972

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-28
• Study Completion Date: 2025-02-28

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.

Conditions

Kidney Disease; Kidney Failure; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Surgical fistula creation from patient's anatomy

Intervention Type: PROCEDURE

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.

Surgical graft implant

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

Group Type: ACTIVE_COMPARATOR

Surgical fistula creation from patient's anatomy

Intervention Type: PROCEDURE

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.

Surgical Graft implant

Intervention Type: DEVICE

Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Other Intervention Names

Fistula; FDA approved graft (various manufacturers)

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: collaborator

E. Peden, MD

OTHER

Sponsor Role: lead

Responsible Party

E. Peden, MD

Sponsor-Investigator/Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eric K Peden, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bright Benfor, MD

Role: CONTACT

bbenfor@houstonmethodist.org

713-441-0147

Bevin A Lopez, MS,CEP,CCRP

Role: CONTACT

balopez@houstonmethodist.org

346-320-7421

Facility Contacts

Bright Benfor, MD

Role: primary

bbenfor@houstonmethodist.org

713-441-0147

Bevin A Lopez, MS,CEP,CCRP

Role: backup

balopez@houstonmethodist.org

346-320-7421

Other Identifiers

Pro00013220

Identifier Type: -

Identifier Source: org_study_id