Trial Summary
What is the purpose of this trial?This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Hemodialysis Access Techniques for Chronic Kidney Disease in the Elderly is an effective treatment?
The available research shows that creating arteriovenous fistulas (AVF) and grafts (AVG) is a common and effective way to provide access for hemodialysis in elderly patients with chronic kidney disease. One study found that in older patients, using AVG can be more effective than AVF, especially when considering the long-term use of the access. Another study highlights that while AVF is often preferred, AVG can be a valid alternative when AVF is not suitable due to health conditions or other factors. Overall, these techniques are important for ensuring that elderly patients can receive the dialysis they need.
12345What safety data exists for hemodialysis access techniques in the elderly?
The safety data for hemodialysis access techniques, including autologous arteriovenous fistula (AVF) and arteriovenous graft (AVG), indicate several considerations. AVF creation is a critical procedure with risks such as non-maturation, early failure, high blood flow leading to heart failure, or hand ischemia. Studies suggest that while AVF is generally recommended, the benefits over AVG in older adults are less certain due to age-related changes. Pilot trials and reviews highlight the need for patient-centered approaches and the importance of evaluating outcomes like muscle strength, gait speed, and quality of life. The historical context shows AVF as a gold standard, but ongoing research aims to optimize techniques and outcomes for elderly patients.
15678Is surgical fistula creation a promising treatment for elderly patients with chronic kidney disease?
Yes, surgical fistula creation is a promising treatment for elderly patients with chronic kidney disease. It is considered the gold standard for hemodialysis access, providing a reliable and effective way to connect patients to dialysis machines. This method uses the patient's own blood vessels, which can lead to better outcomes and fewer complications compared to synthetic options. It is especially beneficial for those who can have this type of access created, as it can improve their quality of life by reducing the need for dialysis catheters.
1591011Eligibility Criteria
This trial is for people aged 70 or older with advanced kidney disease who need hemodialysis and can have surgery to create a dialysis access. They must be currently on hemodialysis due to previous access failure, and not have bleeding disorders, active infections, certain vein issues unless recently imaged, or an inability to follow the study plan.Inclusion Criteria
I am expected to start hemodialysis within the next 6 months.
I am 70 years old or older.
My blood vessels are suitable for creating a connection for dialysis.
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Exclusion Criteria
My surgery involved creating a fistula instead of using a graft.
You have a narrow central vein, but you can still participate if you have a catheter or pacemaker and had a vein check within the last 6 months.
I cannot or will not follow the study's follow-up requirements.
+2 more
Participant Groups
The study compares two surgical methods for creating dialysis access in elderly patients: making a fistula from their own blood vessels or implanting a synthetic graft. It's randomized-controlled, meaning participants are randomly assigned to one of these two groups without knowing which one.
2Treatment groups
Active Control
Group I: Surgical graft implantActive Control2 Interventions
Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.
Group II: Surgical fistula creation from patient's anatomyActive Control1 Intervention
Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.
Surgical fistula creation from patient's anatomy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Autologous Arteriovenous Fistula for:
- End-stage renal disease requiring hemodialysis
🇪🇺 Approved in European Union as Autologous Arteriovenous Fistula for:
- Chronic kidney disease stage 5 requiring hemodialysis
🇨🇦 Approved in Canada as Autologous Arteriovenous Fistula for:
- End-stage renal disease requiring hemodialysis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Houston Methodist HospitalHouston, TX
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Who Is Running the Clinical Trial?
E. Peden, MDLead Sponsor
The Methodist Hospital Research InstituteCollaborator
References
Surgical creation of upper extremity arteriovenous fistula and grafts: a narrative review. [2023]Surgical creation of arteriovenous fistulas (AVF) and grafts (AVG) continues to be the mainstay access for hemodialysis (HD). Avoidance of dependence on dialysis catheters continues to be a worldwide mission in dialysis access. Importantly, there is no one-size-fits-all approach to hemodialysis access and each patient should undergo access creation that is patient-centered. The aim of this paper is to review the literature, current guidelines, and discuss the common types of upper extremity hemodialysis access and their reported outcomes. We will also share our institutional experience regarding the surgical creation of upper extremity hemodialysis access.
Remarks on surgical strategy in creating vascular access for hemodialysis: 18 years of one center's experience. [2017]The aim of the study is to evaluate surgical methods for creating vascular access for hemodialysis (HD) in patients with chronic renal failure. Over the last 18 years, 1,827 surgical procedures were performed in 722 patients (399 men and 323 women, mean age 43.7 +/- 17 years) in order to provide and maintain permanent vascular access for HD. Among all the surgical procedures, 992 were based on the construction of arteriovenous fistulas (AVF) and 835 were undertaken as secondary reparative surgical procedures. A total of 992 vascular accesses have been performed, including 904 AVF on upper and 14 on lower extremities as well as insertion of 74 permanent catheters. Radiocephalic AVF (RCAVF) was the principal type of AVF (58.8%). While constructing secondary angio-access after using RCAVF on the other extremity, fistulas with usage of brachial vessels were preferred. A total of 228 AVF of this type were created, including 143 brachiocephalic (BCAVF) and 85 brachiobasilic (BBAVF) AVF. Lately, synthetic grafts (arteriovenous graft, AVG) have been used more frequently, in 90 AVF. A brachial straight graft was the main type procedure performed, with polytetrafluoroethylene (95.6%). The patency of the fistulas has been evaluated. Kaplan-Meier survival curves were calculated to determine primary, primary-assisted, and secondary patency. Log-rank analysis was used to determine differences between curves. Primary, primary-assisted, and secondary patency at 12 months and 24 months were calculated. Comparing AVF patency in two patients' age periods (18-65 years, >65 years), it may be concluded that in the elderly group AVG provides better treatment for AVF. Finally, we conclude that a multidisciplinary approach to vascular access strategy offers the best option to achieve good functional AVF. Autogenous arteriovenous access should be regarded as the most suitable type in creating VA. However, individual conditions should be taken into consideration.
A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study. [2022]Although older adults encompass almost half of patients with advanced chronic kidney disease, it remains unclear which long-term hemodialysis vascular access type, arteriovenous fistula or arteriovenous graft, is optimal with respect to effectiveness and patient satisfaction. Clinical outcomes based on the initial AV access type have not been evaluated in randomized controlled trials. This pilot study tested the feasibility of randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access surgery.
The vascular access in the elderly: a position statement of the Vascular Access Working Group of the Italian Society of Nephrology. [2018]The incident hemodialysis (HD) population is aging, and the elderly group is the one with the most rapid increase. In this context it is important to define the factors associated with outcomes in elderly patients. The high prevalence of comorbidities, particularly diabetes mellitus, peripheral vascular disease and congestive heart failure, usually make vascular access (VA) creation more difficult. Furthermore, many of these patients may have an insufficient vasculature for fistula maturation. Finally, many fistulas may never be used due to the competing risk of death before dialysis initiation. In these cases, an arteriovenous graft and in some cases a central venous catheter become a valid alternative form of VA. Nephrologists need to know what is the most appropriate VA option in these patients. Age should not be a limiting factor when determining candidacy for arteriovenous fistula creation. The aim of this position statement, prepared by experts of the Vascular Access Working Group of the Italian Society of Nephrology, is to critically review the current evidence on VA in elderly HD patients. To this end, relevant clinical studies and recent guidelines on VA are reviewed and commented. The main advantages and potential drawbacks of the different VA modalities in the elderly patients are discussed.
Autologous arteriovenous fistula creation by nephrologists. [2009]In 1966, physicians from the Bronx Veterans Administration Hospital, New York City described the surgical creation of a distal radial artery to cephalic vein AV fistula. This novel configuration, for the first time, allowed effective and reproducible cannulation for hemodialysis access and has remained the gold standard for hemodialysis access since. More than 40 years later, vascular access remains the Achilles' heel of hemodialysis therapy. In this article, we will review the outcomes and techniques of the pre-eminent nephrologist-surgeons from around the world in an attempt to define those elements that are necessary for successful autologous fistula creation. The hope is that these elements may be employed by others in an effort to increase the numbers and durability of autologous fistulae in incident and prevalent hemodialysis patients, particularly in the United States.
Computational model for prediction of fistula outcome. [2017]The creation and management of an autologous arteriovenous fistula (AVF) as vascular access (VA) for hemodialysis patients is still a critical procedure. The placement of a functional and long-lasting VA derives from adequate planning of the surgical procedure based on physical examination, vascular mapping and selection of the best modality for arteriovenous anastomosis. The risk of AVF non-maturation and early failure is high, even when all precautions are taken to minimize these events. In addition, AVF surgery may develop very high blood flow exposing the patient to the risk of heart failure or hand ischemia.
Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. [2022]It is unclear whether surgical placement of an arteriovenous (AV) fistula (AVF) confers substantial clinical benefits over an AV graft (AVG) in older adults with end-stage kidney disease (ESKD). We report vascular access outcomes of a pilot clinical trial.
A randomized pilot study comparing graft-first to fistula-first strategies in older patients with incident end-stage kidney disease: Clinical rationale and study design. [2023]Timely placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV graft [AVG]) is necessary to limit the use of tunneled central venous catheters (TCVC) in patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD). National guidelines recommend placement of AVF as the AV access of first choice in all patients to improve patient survival. The benefits of AVF over AVG are less certain in the older adults, as age-related biological changes independently modulate patient outcomes. This manuscript describes the rationale, study design and protocol for a randomized controlled pilot study of the feasibility and effects of AVG-first access placement in older adults with no prior AV access surgery. Fifty patients age ≥65 years, with incident ESKD on HD via TCVC or advanced kidney disease facing imminent HD initiation, and suitable upper extremity vasculature for initial placement of an AVF or AVG, will be randomly assigned to receive either an upper extremity AVG-first (intervention) or AVF-first (comparator) access. The study will establish feasibility of randomizing older adults to the two types of AV access surgery, evaluate relationships between measurements of preoperative physical function and vascular access development, compare vascular access outcomes between groups, and gather longitudinal assessments of upper extremity muscle strength, gait speed, performance of activities of daily living, and patient satisfaction with their vascular access and quality of life. Results will assist with the planning of a larger, multicenter trial assessing patient-centered outcomes.
Vascular access for hemodialysis: thrills and thrombosis. [2010]Hemodialysis is a life saving treatment for Americans with end stage renal disease. In the last decade, liberal selection of patients treated by hemodialysis has resulted in patients who are substantially older, diabetics, who have higher co-morbidities including extensive atherosclerotic vascular disease. Many of these patients start hemodialysis treatments with a synthetic graft access rather than with their own native vessels. Grafts are appropriate for patients with inadequate vessels for construction of an arterio-venous (A-V) fistulas. The National Kidney Foundation published the Dialysis Outcome Quality Initiative (DOQI) guidelines in 1997, a set of evidenced based guidelines regarding the optimal management of vascular access. One important guideline had been to increase the number of patient dialyzing with Arterio-Venous (A-V) fistulas rather than A-V grafts which are prone to frequent stenosis, thrombosis, and thus are more costly and labor intensive. The prevalence of patient dialyzing with fistulas depends on several factors; timing of the referral, anatomy and adequacy of the patients vessels, type of fistula placed, fistula maturation, minimal accepted dialysis blood flow and patency of the fistula. The management of a vascular access for hemodialysis is a challenging area of practice for those who care for the hemodialysis patient population. The multidisciplinary approach to management of patients with hemodialysis access includes support, education, collaboration and ongoing communication with the multidisciplinary team, patients, and their family members.
Advancements in Access for End-Stage Renal Disease and the Creation of Endovascular Fistulas. [2023]The prevalence of end-stage renal disease has increased significantly since the 1980s, and the demand for successful, safe, and durable hemodialysis access is rising. Autogenous arteriovenous fistulas continue to be the gold standard modality for hemodialysis access. Biologic and synthetic grafts are used with comparable outcomes but are not without their own complications. Newer developments in hemodialysis access utilize endovascular technology, including dual catheter-based systems and thermal resistance devices, which are pushing the boundaries of fistula creation optimistically forward.
Age-related outcomes of arteriovenous grafts for hemodialysis access. [2020]The prevalence of end-stage renal disease spans the spectrum of age. Arteriovenous grafts are viable alternatives for hemodialysis access in patients whose anatomy precludes placement of an arteriovenous fistula. This report describes the age-related outcomes after arteriovenous graft placement in a population-based cohort.