Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease

Not Applicable

Completed

Conditions: Kidney Diseases

Interventions: Procedure: Upper arm arteriovenous graft surgery
Procedure: Upper arm arteriovenous fistula surgery

Registration Number: NCT03545113

Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper extremity arteriovenous graft (AVG) - first	Upper arm arteriovenous graft surgery	Participants randomized to receive an AVG will undergo surgery to have an AVG placed.
Upper extremity arteriovenous fistula (AVF) - first	Upper arm arteriovenous fistula surgery	Participants randomized to receive an AVF will undergo surgery to have an AVF created.

Primary Outcome Measures

Name	Time	Method
Feasibility- Consent to Randomization	12 months	Proportion of eligible participants who consent to randomization.
Feasibility- AV Graft or Fistula Placement	Day 90	Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.
Feasibility- Eligibility for Randomization	12 months	Proportion of screened participants deemed eligible for randomization.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level	3 and 6 months	The Rapid Assessment of Physical Activity (RAPA) instrument will be used to assess habitual physical activity. RAPA test score ≤ 3 corresponded to a sedentary lifestyle or a very light activity level; values ≥4 indicated a moderate to vigorous active lifestyle.
Upper Extremity Strength	3 and 6 months	The grip-strength test will be performed twice on each hand for each assessment and the mean of the two results will be used for statistical analyses; a cut-off point \<16 kg in women and \<26 kg in men will define muscle weakness. Changes in grip strength will be compared between the two access interventions. Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer.
Depression	3 and 6 months	Depression scores assessed with the patient health questionnaire (PHQ-9) will be compared between the two vascular access arms. PHQ-9 score range 0-27. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores	Baseline, Month 3, and Month 6	The impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.
Number of Subjects With No Pain at the AV Access Site	Baseline, 3 and 6 months	This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Number of Subjects With Mild Pain at the AV Access Site	Baseline, Month 3 and Month 6	This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Physical Activity Level 4-meter Gait	Baseline, month 3 and 6	The 4MGS test is a simple screening test and a useful predictor of worsening daily activity in patients with chronic respiratory diseases.
Number of Subject With Moderate Pain at the AV Access Site	Baseline, Month 3 and Month 6	This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Number of Subjects With Severe Pain at the AV Access Site	Baseline, Month 3 and Month 6	This will be determined by using the Verbal Descriptor Scale (VDS). The Verbal Descriptor Scale (VDS) is comprised of a series of descriptive phrases that refer to different levels of pain severity or intensity. Patients select the phrase that best describes their current pain - The verbal descriptor scale asks the patient to describe her or his pain using the following descriptors: "no pain," "mild pain," "moderate pain," "severe pain," or "pain as bad as it could be."
Patient Satisfaction With Vascular Access	3 and 6 months	Vascular access questionnaire will be used to assess differences in patient satisfaction with vascular access between the two access interventions using the short-form vascular access questionnaire (SF-VAQ). Mean scores obtained on SF-VAQ will be compared. SF-VAQ score range 4 -20 with higher scores indicating more satisfaction with the vascular access.
Performance on Activities of Daily Living (ADLs)	Baseline and 6 months	The level of independence will be evaluated using ADLs. ADL score range 0-30, with higher scores denoting more dependence on other people to perform the usual daily activities.
Performance on Activities of Instrumental Daily Living ADLs (IADLs)	Baseline, 3 and 6 months	The level of independence will be evaluated using IADLs instruments. ADL score range 0-31, with higher scores denoting more dependence on other people.
Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores	3 and 6 months	The impact of the two types of vascular access on HRQoL will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3. which consists of a generic core (Short Form-36 \[SF-36\]) and an 11-item kidney disease-specific scale. Score range 0 to 100, with higher scores reflecting better quality of life.