Catheter vs Fistula for Hemodialysis in Kidney Failure

(ACCESS HD Trial)

Not currently recruiting at 7 trial locations

Overseen By Sorcha Mulligan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Fistula, Graft, Transplant, Malignancy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to access blood vessels for hemodialysis in people with end-stage kidney failure. It compares two methods: using a catheter (a thin tube inserted into a vein) and creating a fistula (a surgical connection between an artery and vein). The goal is to determine which method is safer and more effective for patients. Those who have started hemodialysis with a catheter and have not had more than one unsuccessful fistula attempt might be suitable candidates for this trial. As an unphased trial, this study allows participants to contribute to important research that could improve future hemodialysis procedures.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these vascular access strategies are safe for hemodialysis in elderly patients?

Research has shown that using a fistula for hemodialysis can lead to better long-term outcomes. One study found that patients with a fistula had a lower risk of death over seven years compared to those without one. However, creating a fistula can sometimes be challenging. Factors like body weight and certain blood levels can cause complications, and some people might need additional surgeries to maintain fistula function.

In contrast, using a catheter is common but usually considered a temporary solution. Catheters are easier to insert but carry higher risks of infections and other issues over time.

Both methods have their pros and cons. Fistulas might offer a longer-lasting solution with fewer complications in the long run, but they don't always work for everyone immediately. Catheters are simpler to start with but could lead to more problems later. These factors are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing catheter and fistula methods for hemodialysis in kidney failure because it aims to better understand the benefits and drawbacks of each vascular access option. Catheters are unique as they offer a quicker, less invasive setup, which can be advantageous for patients who need immediate dialysis. On the other hand, fistulas, which involve creating a connection between an artery and a vein, are known for their durability and potential to provide long-term access with good blood flow. This trial could help pinpoint which method offers the best balance of convenience and effectiveness, potentially improving patient outcomes in hemodialysis.

What evidence suggests that this trial's treatments could be effective for hemodialysis in kidney failure?

Research has shown that using a fistula for hemodialysis can help patients with kidney failure live longer. Specifically, a fistula lowers the risk of death for those requiring long-term dialysis. Fistulas also tend to remain open and function well over time compared to catheters. Although fistulas might not work perfectly at first, they usually provide better blood flow and can last for years. This trial will compare the effectiveness of fistulas with catheters, another method of vascular access for hemodialysis. Findings suggest that fistulas could be a more effective choice for many patients needing ongoing dialysis. ^{1 2 6 7 8}

Who Is on the Research Team?

Rob Quinn

Principal Investigator

University of Calgary

Pietro Ravani

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for elderly patients aged 55 or older (65 in Australia) who have started hemodialysis with a catheter due to end-stage kidney failure and are either new to dialysis or switching from peritoneal dialysis without a working fistula. They should be stable, able to consent, planning to stay at the current center for 6+ months, and eligible for a fistula attempt.

Inclusion Criteria

I am mentally stable and able to make my own medical decisions since starting hemodialysis.

I started hemodialysis with a catheter and had at most one failed fistula attempt, or I switched from peritoneal dialysis without a working fistula.

My medical team has approved me for a fistula procedure.

Exclusion Criteria

I am on hemodialysis with a fistula, or have tried and failed to get one.

My doctor thinks I have less than 6 months to live due to my condition.

I have had surgery to create a connection between an artery and vein.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 months

1 visit (in-person)

Site Preparation

Preparation of sites for participant recruitment and protocol adherence

6 months

Participant Accrual

Participants are enrolled and randomized to either catheter or fistula groups

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Data Analysis and Reporting

Assessment of preliminary data and preparation of reports for the vanguard phase

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Catheter
• Fistula

Trial Overview

The ACCESS HD trial is comparing two methods of vascular access in elderly patients starting hemodialysis: creating an arteriovenous fistula versus continuing with a catheter. It's designed as an open-label randomized controlled trial across multiple centers involving 100 participants initially.

How Is the Trial Designed?

Group I: Fistula Experimental Treatment 1 Intervention

Fistula is a type of vascular access strategy for hemodialysis in which a direct connection of an artery to a vein is created. It is intended to provide an access with good blood flow that can last for decades.

Group II: Catheter Active Control 1 Intervention

Catheter is a method of vascular access for hemodialysis. It consists of a long, thin plastic tube and may be either tunnelled or non-tunnelled.

Catheter is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Central Venous Catheter for:

• Hemodialysis access

Approved in United States as Central Venous Catheter for:

• Hemodialysis access
• Temporary vascular access

Approved in Canada as Central Venous Catheter for:

• Hemodialysis access

Approved in Japan as Central Venous Catheter for:

• Hemodialysis access

Approved in China as Central Venous Catheter for:

• Hemodialysis access

Approved in Switzerland as Central Venous Catheter for:

• Hemodialysis access

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Applied Health Research Centre

Collaborator

Trials

23

Recruited

70,900+

The George Institute

Collaborator

Trials

84

Recruited

275,000+

Published Research Related to This Trial

In a study of 72 chronic hemodialysis patients using non-tunneled catheters, catheter-related complications, particularly infections, were significant, leading to a third of catheter removals and a high mortality rate (64.7%) among those with infections.

The study found that unemployment and longer catheter duration were associated with higher rates of complications, highlighting the need for improved patient management and timely referrals to nephrologists for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of non-tunneled non-cuffed hemodialysis catheters in patients on chronic hemodialysis in a resource limited sub-Saharan Africa setting. Kaze, FF., Ashuntantang, G., Halle, MP., et al.[2014]

The endoluminal dilation technique was successfully used to remove a stuck tunneled catheter in a 63-year-old female patient, demonstrating its effectiveness and safety in such cases.

This case represents the first reported instance of a stuck hemodialysis catheter treated with endoluminal dilation in Indonesia, highlighting the technique's potential as a standard approach for similar complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoluminal dilatation technique to remove stuck hemodialysis tunneled catheter: A case report from Indonesia. Darwis, P., Limengka, Y., Muradi, A., et al.[2021]

In a study of 222 chronic hemodialysis patients, there was no significant difference in overall symptom scores between those using central venous catheters and those using arteriovenous fistulas, indicating similar levels of reported discomfort.

However, patients with fistulas reported being more bothered by issues like pain and appearance, especially among elderly patients, suggesting that patient education on the risks of catheters and improving fistula-related complications could enhance satisfaction and potentially increase fistula use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Vascular Access Questionnaire: assessing patient-reported views of vascular access. Quinn, RR., Lamping, DL., Lok, CE., et al.[2022]

In a study involving 22 urgent start dialysis patients, tunneled femoral vein catheters were inserted without any complications or catheter-related infections, demonstrating their safety and effectiveness as a temporary access method.

Patients reported high satisfaction with the femoral vein catheters, experiencing minimal issues such as bruising or swelling, and the primary complaint was mild pain at the exit site, which did not affect their daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using tunneled femoral vein catheters for "urgent start" dialysis patients: a preliminary report. Hingwala, J., Bhola, C., Lok, CE.[2017]

In a study of 138 hemodialysis patients, tunneled central venous catheters (TCVC) were primarily used as a temporary solution while waiting for arteriovenous fistulas (AVF) to mature, with an average lifespan of about 141 days.

While complications occurred in 46% of procedures, most were benign; however, significant risks included infections and thrombosis, particularly in patients with a history of heart disease or low hemoglobin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunneled catheters in hemodialysis: Indications and complications. Chouhani, BA., Kabbali, N., Chiba Bennani, S., et al.[2022]

High-flow tunneled central venous catheters (DualCath) can achieve effective blood flow rates comparable to arteriovenous accesses (AVAs) in dialysis patients, with a baseline effective blood flow close to 400 mL/min.

Despite slightly lower dialysis doses and higher recirculation rates compared to AVAs, DualCath catheters maintained stable clinical performance indicators over 30 months, demonstrating their reliability for high volume hemodiafiltration without compromising patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Clinical Performances of Tunneled Central Venous Catheters versus Arterio-Venous Accesses in Patients Receiving High-Volume Hemodiafiltration: The Case for High-Flow DualCath, a Tunneled Two-Single-Lumen Silicone Catheter. Canaud, B., Leray-Moragues, H., Chenine, L., et al.[2023]

Over 80% of patients in the U.S. start hemodialysis with central venous catheters, despite guidelines recommending alternatives to reduce catheter use.

Tunneled dialysis catheters, while having some benefits, are associated with numerous complications that often outweigh their advantages, highlighting the need for better vascular access strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of catheters: tunneled and nontunneled. Vats, HS.[2022]

In a case study of a 54-year-old male with end-stage renal disease, a dysfunctional right jugular hemodialysis catheter was identified, highlighting the importance of monitoring catheter function in dialysis patients.

The study suggests that using contrast studies for early evaluation of dysfunctional catheters can provide accurate information, potentially improving patient outcomes in dialysis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially fatal atrium perforation due to right jugular vein catheterization recognized by venography: A case report. Jahanshahi, F., Parsaei, A., Naderi, D., et al.[2023]

In cases of acute kidney injury requiring immediate hemodialysis, tunneled, cuffed catheters are often necessary when arteriovenous access is not viable due to complications or immaturity.

Proper care of dialysis central venous catheters is crucial to prevent central line-associated bloodstream infections in acutely ill patients, emphasizing the importance of quality improvement in catheter management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of hemodialysis central line-associated bloodstream infections in acutely ill individuals. Smith, NC.[2010]

Patients who had fistula creation attempts before starting dialysis (predialysis) were significantly more likely to achieve catheter-free use within one year (80%) compared to those who had attempts after starting dialysis (postinitiation) at 45%.

Predialysis attempts not only increased the likelihood of remaining catheter-free over time but also resulted in fewer access-related procedures after starting dialysis, indicating a potential benefit in timing for fistula creation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Fistula Creation and the Probability of Catheter-Free Use: A Cohort Study. Clarke, A., Ravani, P., Oliver, MJ., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12028852/

Vascular Access Type and Survival Outcomes in ...

The analysis revealed that having an AVF significantly reduced mortality in hemodialysis patients after 7 years of follow-up. The statistical ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3156429/

Outcomes of Arteriovenous Fistula Creation after the Fistula ...

The primary failure rate was 37.1% after excluding patients not initiated on hemodialysis during follow-up (n = 38) or those with indeterminate outcome (37 lost ...

3.

academic.oup.com

academic.oup.com/ckj/article/17/12/sfae345/7900669

Impact of arteriovenous fistula formation on trajectory of kidney ...

The 5-year absolute risk of dialysis was 87% (95% CI 84, 91) in the AVF group and 75% (95% CI 73, 77) in the no AVF group, and the 5-year ...

4.

jvascsurg.org

jvascsurg.org/article/S0741-5214(16)00216-0/fulltext

Outcomes of vascular access for hemodialysis

The overall primary patency at 2 years was higher for fistulas than for grafts and catheters (55%, 40%, and 50%, respectively). Patency was lower in individuals ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0741521425017744

Outcomes of Snuffbox Arteriovenous Fistula as a First Line ...

Key Findings: Snuffbox AVF procedures were performed on 258 patients. Primary patency rates were 94% at 1 month, 87% at 6 months, and 79% at 1 ...

6.

nature.com

nature.com/articles/s41598-023-48691-4

Risk factors for arteriovenous fistula dysfunction in ...

AVF dysfunction is highly associated with several risk factors including weight, phosphorus level, and sex.

7.

jvascsurg.org

jvascsurg.org/article/S0741-5214(23)01146-1/fulltext

Health care disparities involved in establishing functional ...

Black patients were at significantly higher risk of undergoing additional surgical procedures, including both maintenance and new fistula creations.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949912725000224

Extravascular supported arteriovenous fistulas reduced the ...

The outcomes of patients who stopped hemodialysis before the 3-month timepoint were adjudicated based on investigator assessment of fistula functionality.