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The Arteriovenous Vascular (AV) ACCESS Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646226
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Hemodialysis Complication Device: AV graft Procedure: surgical intervention for creation of a fistula Not Applicable

Detailed Description:
This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study will determine if placement of a graft access will be more effective at having access switched from catheter to using the graft; have fewer interventions on the graft access; have better arm function; have better self-sufficiency with daily activities; and better quality of life compared to those who receive a fistula - identify strategies that decrease dialysis access failure and improve quality of life
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fistula surgically placed
Randomized group to have surgically placed fistula for permanent hemodialysis access
Procedure: surgical intervention for creation of a fistula
The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

Active Comparator: graft surgically placed
Randomized group to have surgically placed graft for permanent hemodialysis access
Device: AV graft
The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)




Primary Outcome Measures :
  1. Number of Catheter-free dialysis days [ Time Frame: Until death, collected up to 4 years ]
    Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

  2. Number of Infections [ Time Frame: Until death, collected up to 4 years ]
    Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment


Secondary Outcome Measures :
  1. Vascular access-related cost per patient-year [ Time Frame: Year 2 ]
    The total cost will represent the sum of costs for adjuvant procedures (endovascular and surgical) related to fistula or graft access; central venous catheter (CVC) - related interventions; infectious complications related to fistula or graft access; infectious complications related to CVC; and hospitalizations related to fistula or graft access and/or CVC. All access-related costs will be expressed as mean cost (in U.S. dollars) per patient per year

  2. Incidence rate of study fistula/graft primary maturation failure [ Time Frame: hour 72, Month 3, Month 6, and Year 4 ]
    Study fistula or graft primary maturation failure is defined as permanent failure of the fistula or graft before hemodialysis suitability, and the study fistula or graft access was abandoned. Causes of fistula or graft primary maturation failure include inadequate vasculature, thrombosis, inability to achieve successful cannulation, and other complications leading to nonfunctional fistula or graft - Abandonment of the study fistula or graft access is defined as the point at which the fistula or graft access cannot be cannulated and no further attempts will be made to rescue or revise the access

  3. Time to successful fistula/graft access cannulation [ Time Frame: Until death, collected up to 4 years ]
    This is the time from the date of surgical creation of study AV access (fistula or graft) to the date of successful access cannulation. The date of successful access cannulation is defined as the date when the study fistula or graft access became the primary vascular access for hemodialysis (i.e., the fistula or graft access became the sole vascular access for hemodialysis and the CVC was removed)

  4. Incidence rate of fistula/graft access hemodialysis suitability [ Time Frame: Month 6 ]
    Study AV access use (fistula or graft) with two needles for at least 8 out of 12 hemodialysis sessions occurring during the 30-day suitability ascertainment period

  5. Functional patency of study fistula or graft access [ Time Frame: Until death, collected up to 4 years ]
    Total duration of successful use of the study fistula or graft access (i.e., the study fistula or graft access was the sole means of hemodialysis vascular access)

  6. Rate of adjuvant endovascular and surgical procedures [ Time Frame: Until death, collected up to 4 years ]
    All endovascular and surgical procedures performed to evaluate the study fistula or graft access, or to aid or maintain study fistula or graft access functional patency will be included in this outcome. Adjuvant endovascular interventions include: percutaneous thrombectomy; percutaneous revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; and dilation of central venous stenosis. Adjuvant surgical interventions include: surgical thrombectomy; dilation of central venous stenosis; surgical revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; ligation of tributaries; superficialization of study fistula; second-stage planned procedure for brachio-basilic fistula creation; ligation of fistula or salvage by distal reconstruction and interval ligation due to distal ischemia.


Other Outcome Measures:
  1. Vascular Access Score [ Time Frame: baseline and Months 6 and 12 ]
    Satisfaction with different processes of vascular access care (catheter, fistula, or graft) - vascular access questionnaire (VAQ) - satisfaction with the vascular access using the vascular access questionnaire - patient-reported questionnaire composed of 17 vascular access related questions with responses on a five-point Likert scale which are summed, to give a Vascular Access Score- Score range is 4 to 20, with lower scores indicating more satisfaction with the vascular access

  2. SUPPORT Trial questionnaire [ Time Frame: baseline and Months 6, and 12 ]
    Will be based on the SUPPORT Trial questionnaire which has two items. The first question asks patients to choose their top priority, extension of life or relieving discomfort as much as possible. The second question asks patients to use the same categories to describe the focus of AV access care they received - This questionnaire will be analyzed using qualitative methods

  3. Decision Regret Scale [ Time Frame: Months 6, and 12 ]
    Measuring the regret of AV access placement will be assessed using the Decision Regret Scale - The Decision Regret Scale is a 5-item Likert-type measure written to assess regret or remorse following a medical decision. Patients respond to the items after reading the prompt: "Please think about the decision you made about [chosen health care decision] after talking to your [doctor, surgeon, nurse, health professional, etc.]." High scores suggest high regret over a health care decision. Scores may be transformed to a scale of 0 (no regret) to 100 (high regret)

  4. Attitude Scale [ Time Frame: Months 6, and 12 ]
    Participant's preferences between quantity and quality of life and future/present health using the Attitude Scale - An attitude scale is designed to provide a valid, or accurate, measure of an individual's social attitude - The Attitude Scale is composed of 9 items in which participants are asked to rate the strength of the statements, each representing a tradeoff between quality and quantity of life; total score range 9 to 45, with higher scores denoting that quality of life/current health is more important than quantity of life/future health

  5. Grip strength [ Time Frame: Months 1, 6, and 12 ]
    Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer - A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg - A cut-off point <16 kg in women and <26 kg in men will define muscle weakness

  6. Chair stand test [ Time Frame: Months 1, 6, and 12 ]
    The chair stand testing will be a timed repetition of rising from a chair and sitting down five times. The test will be scored based on the time (seconds) it takes to complete the five consecutive stand-up-sit-down workouts - longer times denotes worse outcomes. The score ranges from 0 to 4 based on pre-established time cut-offs: 4 points if ≤11.19 sec, 3 points if 11.20-13.69 sec, 2 points if 13.70-16.69 sec, 1 point if ≥16.70 sec, and 0 points if >60 sec or unable.

  7. Clinical Frailty Scale [ Time Frame: Months 1, 6, and 12 ]
    Participant's level of frailty using the Clinical Frailty Scale - The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill) -The scale will be graded from 1 to 7 (1, severely frail; 2, moderately frail; 3, mildly frail; 4, apparently vulnerable; 5, well with treated comorbid disease; 6, well without active disease; 7, very fit

  8. Pepper Assessment Tool for Disability (PAT-D) [ Time Frame: Months 1, 6, and 12 ]
    Self-report disability questionnaire using the Pepper Assessment Tool for Disability - The PAT-D self-administered questionnaire consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). For each item, respondents answer whether they experience (1) unable to do, (2) a lot of difficulty, (3) some difficulty, (4) a little difficulty, (5) no difficulty. The summary score, a mean of the three domain scores that ranges from 1 to 5, is an indication of a person's overall perceived disability.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 years or older
  • End-stage kidney disease on hemodialysis via a central venous catheter
  • Hemodialysis is the long-term modality of treatment for end-stage kidney disease
  • Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
  • Referred by patient's nephrologist for placement of arteriovenous access
  • At least one of the following comorbid conditions: coronary artery disease, peripheral arterial disease, and/or diabetes mellitus
  • Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
  • Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
  • Patient agreed to study participation and signed the informed consent

Exclusion Criteria:

  • Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
  • Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
  • Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
  • Anticipated kidney transplant within 12 months
  • Anticipated conversion to peritoneal dialysis within 12 months
  • Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
  • Anticipated non-compliance with medical care based on physician judgment
  • A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646226


Contacts
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Contact: Brindusa Burciu 336-716-8671 bburciu@wakehealth.edu
Contact: Ben Bagwell 336-716-5777 bbagwell@wakehealth.edu

Locations
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United States, Alabama
University of Alabama at Birmingham School of Medicine Recruiting
Birmingham, Alabama, United States, 35487
Contact: Timmy Lee       tclee@uabmc.edu   
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Karen Woo       kwoo@mednet.ucla.edu   
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Geetha Duvuru       gduvura@jhmi.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: John P Middleton       j.p.middleton@duke.edu   
United States, Ohio
Cleveland Clinic Glickman Urological and Kidney Institute Recruiting
Cleveland, Ohio, United States, 44125
Contact: Tushar Vachharajani       VACHHAT@ccf.org   
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53726
Contact: Ali I Gardezi       AGardezi@uwhealth.org   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Marianna Murea, MD Wake Forest Health Sciences
Principal Investigator: Michael Allon University of Alabama at Birmingham
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04646226    
Other Study ID Numbers: IRB00069593
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available upon investigator request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
Hemodialysis
End-Stage Kidney Disease
central venous catheters
arteriovenous fistula [AVF]
arteriovenous graft [AVG]
Arteriovenous Vascular Access
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency