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

270 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

What 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. ^{1 2 6 7 8}

Is 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. ^{1 2 9 10 11}

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.

Research Team

Eric Peden, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Surgical creation of upper extremity arteriovenous fistula and grafts: a narrative review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Autologous arteriovenous fistula creation by nephrologists. [2009]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Remarks on surgical strategy in creating vascular access for hemodialysis: 18 years of one center's experience. [2017]

4. Italy 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. [2018]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Computational model for prediction of fistula outcome. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. [2022]

8. Netherlands 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Vascular access for hemodialysis: thrills and thrombosis. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Advancements in Access for End-Stage Renal Disease and the Creation of Endovascular Fistulas. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Age-related outcomes of arteriovenous grafts for hemodialysis access. [2020]