A Randomized Pilot Study Comparing Graft-first to Fistula-first Strategies in Older Patients With Incident End-stage Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Feasibility- Consent to Randomization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility- Consent to Randomization
时间窗: 12 months
Proportion of eligible participants who consent to randomization.
Feasibility- AV Graft or Fistula Placement
时间窗: Day 90
Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.
Feasibility- Eligibility for Randomization
时间窗: 12 months
Proportion of screened participants deemed eligible for randomization.
次要结局
- Physical Activity Level(3 and 6 months)
- Upper Extremity Strength(3 and 6 months)
- Depression(3 and 6 months)
- Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores(Baseline, Month 3, and Month 6)
- Number of Subjects With No Pain at the AV Access Site(Baseline, 3 and 6 months)
- Number of Subjects With Mild Pain at the AV Access Site(Baseline, Month 3 and Month 6)
- Physical Activity Level 4-meter Gait(Baseline, month 3 and 6)
- Number of Subject With Moderate Pain at the AV Access Site(Baseline, Month 3 and Month 6)
- Number of Subjects With Severe Pain at the AV Access Site(Baseline, Month 3 and Month 6)
- Patient Satisfaction With Vascular Access(3 and 6 months)
- Performance on Activities of Daily Living (ADLs)(Baseline and 6 months)
- Performance on Activities of Instrumental Daily Living ADLs (IADLs)(Baseline, 3 and 6 months)
- Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores(3 and 6 months)