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The Arteriovenous Vascular (AV) ACCESS Trial

Primary Purpose

End-Stage Kidney Disease, Hemodialysis Complication

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AV graft

surgical intervention for creation of a fistula

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring Hemodialysis, End-Stage Kidney Disease, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 60 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.

Sites / Locations

University of Alabama at Birmingham School of MedicineRecruiting
UCLARecruiting
Johns Hopkins School of MedicineRecruiting
Atrium Wake Forest Baptist Medical CenterRecruiting
Prisma Health UpstateRecruiting
University of Tennessee Medical Center at KnoxvilleRecruiting
University of Wisconsin School of Medicine and Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fistula surgically placed

graft surgically placed

Arm Description

Randomized group to have surgically placed fistula for permanent hemodialysis access

Randomized group to have surgically placed graft for permanent hemodialysis access

Outcomes

Primary Outcome Measures

Number of Catheter-free dialysis days

Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

Number of Infections

Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

Secondary Outcome Measures

Vascular access-related cost per patient-year

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

Incidence rate of study fistula/graft primary maturation failure

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

Time to successful fistula/graft access cannulation

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)

Incidence rate of fistula/graft access hemodialysis suitability

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

Functional patency of study fistula or graft access

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)

Rate of adjuvant endovascular and surgical procedures

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.

Full Information

NCT ID

NCT04646226

First Posted

November 20, 2020

Last Updated

September 11, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04646226

Brief Title

The Arteriovenous Vascular (AV) ACCESS Trial

Official Title

A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

June 30, 2027 (Anticipated)

Study Completion Date

August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Kidney Disease, Hemodialysis Complication

Keywords

Hemodialysis, End-Stage Kidney Disease, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fistula surgically placed

Arm Type

Experimental

Arm Description

Randomized group to have surgically placed fistula for permanent hemodialysis access

Arm Title

graft surgically placed

Arm Type

Active Comparator

Arm Description

Randomized group to have surgically placed graft for permanent hemodialysis access

Intervention Type

Device

Intervention Name(s)

AV graft

Intervention Description

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)

Intervention Type

Procedure

Intervention Name(s)

surgical intervention for creation of a fistula

Intervention Description

The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

Primary Outcome Measure Information:

Title

Number of Catheter-free dialysis days

Description

Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

Time Frame

Until death, collected up to 4 years

Title

Number of Infections

Description

Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

Time Frame

Until death, collected up to 4 years

Secondary Outcome Measure Information:

Title

Vascular access-related cost per patient-year

Description

Time Frame

Year 2

Title

Incidence rate of study fistula/graft primary maturation failure

Description

Time Frame

hour 72, Month 3, Month 6, and Year 4

Title

Time to successful fistula/graft access cannulation

Description

Time Frame

Until death, collected up to 4 years

Title

Incidence rate of fistula/graft access hemodialysis suitability

Description

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

Time Frame

Month 6

Title

Functional patency of study fistula or graft access

Description

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)

Time Frame

Until death, collected up to 4 years

Title

Rate of adjuvant endovascular and surgical procedures

Description

Time Frame

Until death, collected up to 4 years

Other Pre-specified Outcome Measures:

Title

Vascular Access Score

Description

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

Time Frame

baseline and Months 6 and 12

Title

SUPPORT Trial questionnaire

Description

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

Time Frame

baseline and Months 6, and 12

Title

Decision Regret Scale

Description

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)

Time Frame

Months 6, and 12

Title

Attitude Scale

Description

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

Time Frame

Months 6, and 12

Title

Grip strength

Description

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

Time Frame

Months 1, 6, and 12

Title

Chair stand test

Description

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.

Time Frame

Months 1, 6, and 12

Title

Clinical Frailty Scale

Description

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

Time Frame

Months 1, 6, and 12

Title

Pepper Assessment Tool for Disability (PAT-D)

Description

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.

Time Frame

Months 1, 6, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 60 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: cardiovascular disease, peripheral vascular 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brindusa Burciu

Phone

336-716-8671

bburciu@wakehealth.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ben Bagwell

Phone

336-716-5777

bbagwell@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianna Murea, MD

Organizational Affiliation

Wake Forest Health Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Allon

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham School of Medicine

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35487

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timmy Lee

tclee@uabmc.edu

Facility Name

UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Woo

kwoo@mednet.ucla.edu

Facility Name

Johns Hopkins School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caitlyn Hicks

chicks11@jhmi.edu

Facility Name

Atrium Wake Forest Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Goldman

mgoldman@wakehealth.edu

Facility Name

Prisma Health Upstate

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Carsten, MD

Chris.Carsten@prismahealth.org

Facility Name

University of Tennessee Medical Center at Knoxville

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oscar Grandas, MD

OGrandas@utmck.edu

Facility Name

University of Wisconsin School of Medicine and Public Health

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53726

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ali I Gardezi

AGardezi@uwhealth.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Available upon investigator request

Learn more about this trial

The Arteriovenous Vascular (AV) ACCESS Trial

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