N/A
Completed N=44
Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease
Source: ClinicalTrials.gov NCT03545113 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Feasibility- Eligibility for Randomization — 54 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility- Eligibility for Randomization |
54 | — |
| PRIMARY Feasibility- Consent to Randomization |
44 | — |
| PRIMARY Feasibility- AV Graft or Fistula Placement |
18; 21 | — |
| SECONDARY Upper Extremity Strength |
21.3; 22.6; 19.1; 20.4; 19.6; 17.4 | — |
| SECONDARY Patient Satisfaction With Vascular Access |
9.75; 8.82; 7.55; 8.75; 10.1; 9.21 | — |
| SECONDARY Performance on Activities of Daily Living (ADLs) |
4.5; 4.75; 4.2; 5.11 | — |
| SECONDARY Performance on Activities of Instrumental Daily Living ADLs (IADLs) |
5.28; 4.5; 4.4; 6.42 | — |
| SECONDARY Depression |
— | — |
| SECONDARY Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores |
54.38; 46.27; 53.79; 58.2; 53.38; 51.46 | — |
| SECONDARY Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores |
39.02; 39.44; 40.77; 36.12; 29.89; 36.75 | — |
| SECONDARY Physical Activity Level |
— | — |
| SECONDARY Physical Activity Level 4-meter Gait |
7.5; 5.1; 6.88; 6.04; 5.74; 6.34 | — |
| SECONDARY Number of Subjects With No Pain at the AV Access Site |
6; 13; 4; 10; 7; 7 | — |
| SECONDARY Number of Subjects With Mild Pain at the AV Access Site |
6; 1; 2; 1; 0; 0 | — |
| SECONDARY Number of Subject With Moderate Pain at the AV Access Site |
3; 5; 2; 0; 2; 1 | — |
| SECONDARY Number of Subjects With Severe Pain at the AV Access Site |
2; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 65 years
- End-stage kidney disease (ESKD) on chronic hemodialysis (HD)
- 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 as deemed by the vascular surgeon
- 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
Data sourced from ClinicalTrials.gov (NCT03545113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.