Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hospital |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/9/2019 |
| Start Date: | September 4, 2018 |
| End Date: | November 30, 2020 |
| Contact: | Mariana Murea, MD |
| Email: | mmurea@wakehealth.edu |
| Phone: | 3367162074 |
A Randomized Pilot Study Comparing Graft-first to Fistula-first Strategies in Older Patients With Incident End-stage Kidney Disease
Many older adults require hemodialysis for advanced chronic kidney disease, but it is not
clear which permanent vascular access method (fistula or graft) is best with respect to
access effectiveness and patient satisfaction. In this pilot study, the study team will test
the hypothesis that older adults undergoing graft access placement will more effectively
transition from catheter-based to arteriovenous access-based hemodialysis; have fewer
following vascular access procedures; have better upper extremity function; have better
self-sufficiency with daily activities; and better health-related quality of life compared to
those who undergo arteriovenous fistula access placement. The study will establish
feasibility of randomizing older adults to the two types of arteriovenous access surgeries;
evaluate relationships between measurements of pre-operative physical function and vascular
access development; compare vascular access outcomes between the two groups; and gather
longitudinal assessments of upper extremity muscle strength, performance of activities of
daily living, and patients' reports of satisfaction with their vascular access and quality of
life.
clear which permanent vascular access method (fistula or graft) is best with respect to
access effectiveness and patient satisfaction. In this pilot study, the study team will test
the hypothesis that older adults undergoing graft access placement will more effectively
transition from catheter-based to arteriovenous access-based hemodialysis; have fewer
following vascular access procedures; have better upper extremity function; have better
self-sufficiency with daily activities; and better health-related quality of life compared to
those who undergo arteriovenous fistula access placement. The study will establish
feasibility of randomizing older adults to the two types of arteriovenous access surgeries;
evaluate relationships between measurements of pre-operative physical function and vascular
access development; compare vascular access outcomes between the two groups; and gather
longitudinal assessments of upper extremity muscle strength, performance of activities of
daily living, and patients' reports of satisfaction with their vascular access and quality of
life.
Each year, more than 600,000 people in the United States receive life-saving hemodialysis
(HD) treatments for end-stage kidney disease (ESKD), a third of whom are older adults.Timely
placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV
graft [AVG]) is necessary to avoid (or limit) the use of tunneled central venous catheters
(TCVC) for HD. 'Fistula First Catheter Last' national guidelines require placement of AVF as
the AV access of first choice in all patients to achieve better patient survival. However,
the benefits of AVF over AVG are least certain in older adults, as age-related biological
changes independently modulate patient outcomes. Nationally representative cohort studies of
older adults with incident ESKD have shown similar patient survival between those whose first
AV access placed or used was a fistula or a graft.Compared with grafts, fistulas fail more
often and necessitate longer times and more subsequent procedures to aid development,
exposing older patients to time-consuming procedures that may negatively affect upper
extremity strength and erode their quality of life. The contribution of pre-operative
physical function to AV access outcomes and the impact of AV access placement on upper
extremity strength and self-sufficiency have not been evaluated. This pilot trial will
involve older adults with pre-dialysis advanced chronic kidney disease (CKD) or incident ESKD
using a TCVC for HD who had no prior AV access surgery and have upper extremity vasculature
suitable for either fistula or graft placement. Participants will be randomized to receive an
upper extremity AVF-first or AVG-first access for HD. The primary objective of this pilot
trial is to prospectively evaluate patient and vascular access outcomes in a randomized
intervention and in a patient population in whom fistula-first guidelines have been applied
despite the lack of proven benefit and at the detriment of more access failures and
procedures.
(HD) treatments for end-stage kidney disease (ESKD), a third of whom are older adults.Timely
placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV
graft [AVG]) is necessary to avoid (or limit) the use of tunneled central venous catheters
(TCVC) for HD. 'Fistula First Catheter Last' national guidelines require placement of AVF as
the AV access of first choice in all patients to achieve better patient survival. However,
the benefits of AVF over AVG are least certain in older adults, as age-related biological
changes independently modulate patient outcomes. Nationally representative cohort studies of
older adults with incident ESKD have shown similar patient survival between those whose first
AV access placed or used was a fistula or a graft.Compared with grafts, fistulas fail more
often and necessitate longer times and more subsequent procedures to aid development,
exposing older patients to time-consuming procedures that may negatively affect upper
extremity strength and erode their quality of life. The contribution of pre-operative
physical function to AV access outcomes and the impact of AV access placement on upper
extremity strength and self-sufficiency have not been evaluated. This pilot trial will
involve older adults with pre-dialysis advanced chronic kidney disease (CKD) or incident ESKD
using a TCVC for HD who had no prior AV access surgery and have upper extremity vasculature
suitable for either fistula or graft placement. Participants will be randomized to receive an
upper extremity AVF-first or AVG-first access for HD. The primary objective of this pilot
trial is to prospectively evaluate patient and vascular access outcomes in a randomized
intervention and in a patient population in whom fistula-first guidelines have been applied
despite the lack of proven benefit and at the detriment of more access failures and
procedures.
Inclusion Criteria:
- Age ≥ 65 years
- Incident end-stage kidney disease (ESKD) started on chronic hemodialysis (HD) within
90 days prior to screening and recovery of kidney function is unlikely
- Tunneled central venous catheter (TCVC) is the sole vascular access used for HD
- Advanced chronic kidney disease (CKD) expected to require HD initiation within 90 days
of screening and deemed medically necessary by the treating nephrologist to proceed
with arteriovenous (AV) access placement in preparation for HD initiation
- Did not undergo AV access placement in the past
- Medically eligible to receive AV fistula (AVF) or AV graft (AVG) placement as deemed
by the treating nephrologist
- Surgically eligible to receive either an AVF or an AVG
- HD is the intended long-term modality of treatment for ESKD
- Planning to remain within Wake Forest provided health care for at least 12 months
Exclusion Criteria:
- Presence of an AVF or AVG
- Previous attempt(s) for AV vascular access placement
- Native vasculature not suitable for placement of AV access
- Imminent transplant planned (within 6 months)
- Anticipated life expectancy <9 months
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