Hemodialysis Access Techniques for Chronic Kidney Disease in the Elderly

(ELDERLY Trial)

Overseen By Linda Le, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: E. Peden, MD

Disqualifiers: Hypercoagulability, Bleeding disorder, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two surgical methods to create access points for dialysis in elderly patients with severe kidney disease. One method uses the patient's own blood vessels to create a connection (surgical fistula creation), while the other uses a synthetic tube (surgical graft implant) for the same purpose. Researchers aim to determine which option is more effective for those needing dialysis. People aged 70 or older with severe kidney disease who need dialysis access may be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to important research that could enhance dialysis access options for the elderly.

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 prior data suggests that these hemodialysis access techniques are safe for the elderly?

Research has shown that creating an arteriovenous fistula (AVF) through surgery is common but carries some risks. One study found that about 13% of these procedures did not work as intended. Another report noted that while AVFs can be effective, success rates vary, with some functioning properly in only 50% of cases after six months. However, these surgeries are generally safe, with most complications being minor.

For the surgical graft implant option, studies suggest it is similarly safe. One study found no major safety differences between different types of grafts used for hemodialysis. Another study examined a specific type of graft and found it safe and effective for hemodialysis.

Both treatments are used in medical settings and, while they have risks, they are generally well-tolerated. It is important to discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these techniques for improving hemodialysis access in elderly patients with chronic kidney disease because they offer potentially better outcomes compared to standard methods. The surgical fistula creation uses the patient's own blood vessels to form a direct connection, which can lead to longer-lasting and more reliable access for dialysis. On the other hand, the surgical graft implant involves placing a synthetic tube, which may be quicker to mature and ready for use. These approaches aim to enhance the quality and efficiency of dialysis treatment, offering options tailored to the individual needs and conditions of elderly patients.

What evidence suggests that these hemodialysis access techniques are effective for chronic kidney disease?

This trial will compare two hemodialysis access techniques: surgical fistula creation from the patient's anatomy and surgical graft implant. Studies have shown that arteriovenous fistulas (AVFs), which participants in one arm of this trial may receive, usually remain open and function well longer than grafts. AVFs also carry a lower risk of infection and are associated with lower mortality rates. However, only about 50% of AVFs succeed after six months. Arteriovenous grafts (AVGs), which participants in another arm of this trial may receive, are often used when fistulas aren't feasible and can serve as a reliable alternative. While AVGs might not last as long as fistulas, they can quickly and effectively provide access to the bloodstream for hemodialysis. Both options have their advantages and disadvantages, depending on individual health conditions. ^{6 7 8 9 10}

Who Is on the Research Team?

Eric Peden, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft

12 months

Monthly visits for questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Surgical fistula creation from patient's anatomy
• Surgical Graft implant

Trial Overview 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.

How Is the Trial Designed?

Group I: Surgical graft implant Active Control 2 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 anatomy Active Control 1 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

Who Is Running the Clinical Trial?

E. Peden, MD

Lead Sponsor

Trials

2

Recruited

290+

The Methodist Hospital Research Institute

Collaborator

Trials

299

Recruited

82,500+

Published Research Related to This Trial

In a pilot study involving 36 older adults with end-stage kidney disease, both arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) showed a primary access failure rate of 31%, indicating similar initial outcomes for both types of vascular access.

Successful cannulation rates were slightly higher for AVG (62%) compared to AVF (50%), but the differences were not substantial enough to favor one method over the other, suggesting that further research with larger sample sizes is needed to determine the best option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. Robinson, T., Geary, RL., Davis, RP., et al.[2022]

This study will evaluate the feasibility and effects of placing an arteriovenous graft (AVG) first versus an arteriovenous fistula (AVF) in older adults (aged 65 and above) with end-stage kidney disease, aiming to improve vascular access outcomes and patient satisfaction.

Fifty patients will be randomly assigned to receive either AVG or AVF access, and the study will assess preoperative physical function, muscle strength, and quality of life, providing valuable insights for future larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Murea, M., Geary, RL., Edwards, MS., et al.[2023]

The distal radial artery to cephalic vein AV fistula, first described in 1966, has become the gold standard for hemodialysis access due to its effectiveness and reproducibility.

Despite its long-standing use, vascular access remains a significant challenge in hemodialysis, prompting a review of techniques and outcomes to improve the creation and durability of autologous fistulas for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous arteriovenous fistula creation by nephrologists. Mishler, R.[2009]

Hemodialysis is crucial for patients with end-stage renal disease, but the increasing age and comorbidities of these patients have led to a higher reliance on synthetic grafts instead of preferred arterio-venous (A-V) fistulas, which are associated with fewer complications.

The National Kidney Foundation's guidelines emphasize the importance of increasing the use of A-V fistulas due to their lower rates of complications like stenosis and thrombosis, highlighting the need for a multidisciplinary approach to optimize vascular access management in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access for hemodialysis: thrills and thrombosis. Gilpin, V., Nichols, WK.[2010]

In a study of 78,341 hemodialysis patients, age did not significantly affect the maturation time or patency rates of arteriovenous grafts, indicating that older patients can expect similar outcomes as younger patients in terms of graft function.

Interestingly, while older age did not impact graft maturation, it was associated with a lower risk of severe graft infections but an increased risk of mortality, highlighting the complex health dynamics in older patients undergoing hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age-related outcomes of arteriovenous grafts for hemodialysis access. Arhuidese, IJ., Beaulieu, RJ., Aridi, HD., et al.[2020]

Autogenous arteriovenous fistulas remain the gold standard for hemodialysis access due to their safety and effectiveness, despite the rising demand for hemodialysis as end-stage renal disease prevalence increases.

Recent advancements in endovascular technology, such as dual catheter systems and thermal resistance devices, are promising innovations that may enhance the creation and functionality of hemodialysis access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancements in Access for End-Stage Renal Disease and the Creation of Endovascular Fistulas. Katsiroubas, J., Basharkhah, S., Leong, K., et al.[2023]

Elderly patients undergoing hemodialysis often face challenges with vascular access due to high rates of comorbidities like diabetes and heart disease, which can complicate the creation of arteriovenous fistulas.

Despite these challenges, age should not be a barrier to considering arteriovenous fistula creation, and nephrologists should evaluate the most suitable vascular access options, including arteriovenous grafts and central venous catheters, based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The vascular access in the elderly: a position statement of the Vascular Access Working Group of the Italian Society of Nephrology. Lomonte, C., Forneris, G., Gallieni, M., et al.[2018]

In a study involving 722 patients over 18 years, the construction of arteriovenous fistulas (AVF) was the most common method for creating vascular access for hemodialysis, with a focus on radiocephalic AVF, which accounted for 58.8% of cases.

The study found that while autogenous AVF is generally preferred, synthetic grafts (AVG) may offer better outcomes for older patients, highlighting the importance of a personalized approach to vascular access strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remarks on surgical strategy in creating vascular access for hemodialysis: 18 years of one center's experience. Kawecka, A., Debska-Slizień, A., Prajs, J., et al.[2017]

A new web-based application has been developed to predict blood flow outcomes for arteriovenous fistula (AVF) surgeries based on preoperative ultrasound evaluations, which could enhance surgical planning.

By using this numerical tool, surgeons may reduce the risk of AVF non-maturation and complications, leading to better vascular access for hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational model for prediction of fistula outcome. Remuzzi, A., Manini, S.[2017]

The pilot study successfully enrolled 81% of eligible older adults with advanced kidney disease, demonstrating the feasibility of randomizing them to receive either an arteriovenous fistula or graft for vascular access, which is crucial for future larger trials.

Participants assigned to arteriovenous fistula surgery had a quicker placement time (median of 5 days) compared to those assigned to graft surgery (median of 13 days), suggesting that fistulas may offer a more efficient option for vascular access in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study. Murea, M., Geary, RL., Houston, DK., et al.[2022]

Arteriovenous fistulas (AVF) are preferred for hemodialysis access due to their better outcomes compared to grafts, and the choice between them depends on the patient's anatomy and needs, as highlighted by a review of 27 studies and clinical guidelines.

Successful hemodialysis access creation relies on thorough preoperative evaluations, including ultrasound imaging and patient education, as well as meticulous surgical techniques and diligent postoperative care to minimize reliance on dialysis catheters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical creation of upper extremity arteriovenous fistula and grafts: a narrative review. Montelongo, S., Brooks, DE., Klopfenstein, J., et al.[2023]

Citations

1. academic.oup.com academic.oup.com/ckj/article/18/4/sfaf063/8043268

Comparative outcomes of surgical versus percutaneous ... In the creation of AVFs, surgical and endovascular procedures achieved a 100% technical success rate, with no occurrence of serious adverse ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949912725000303

Optimization of the surgical arteriovenous fistula for end- ... The aim of this article is to summarize the data on technical and procedural steps proposed to improve AVF outcomes and understand the conflicts in the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05654103

Study Details | NCT05654103 | Comparing Surgical and ... The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both.

4. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01729-9/fulltext

VasQ U.S. pivotal study demonstrates the safety and ... Arteriovenous fistula (AVF) creation is a commonly performed vascular operation that reports 6-month functional success rates as low as 50%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971302/

The challenging surgical vascular access creation - PMC AVFs have higher primary patency (7), lower risk of infection and lower mortality (8-10) when compared with prosthetic AV grafts (AVGs) or venous catheters (7).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7298797/

A randomized pilot study to evaluate graft versus fistula ... This pilot study tested the feasibility of randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03645681

Evaluating the Safety and Effectiveness of the InnAVasc ... The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772687825000285

Comparing the outcomes of femoral vein transposition ... This study compares the outcomes of Femoral vein transposition (FVT) and Arterovenous Grafts (AVG) in patients without viable upper limb access.

9. ajkd.org ajkd.org/article/S0272-6386(19)31137-0/fulltext

KDOQI Clinical Practice Guideline for Vascular Access A comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access.

10. jchestsurg.org jchestsurg.org/journal/view.html?uid=6176&vmd=Full

Clinical Outcomes of Arteriovenous Graft in End-Stage ... AVG using the axillary vein showed no major differences in safety or functionality compared to AVG using other veins.