Catheter vs Fistula for Hemodialysis in Kidney Failure

(ACCESS HD Trial)

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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized controlled trial (RCT) is multi-center, parallel-arm, and open label. It will test the feasibility and safety of randomizing elderly patients with end-stage kidney failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the following vascular access strategies: (a) attempt at fistula creation (intervention), or (b) continued use of a catheter (comparator). A total number of 100 participants will be enrolled in vanguard phase of the RCT. The rationale for this trial includes: (1) the importance of the intervention question related to the choice of vascular access for patients treated with hemodialysis; (2) lack of evidence from clinical trials for decision-making in this area (only observational studies are available); (3) existing studies which suggest that fistula use is associated with better patient outcomes are very prone to selection bias; (4) need for a clinical trial comparing the impact of the two most frequently chosen strategies for vascular access (catheter and fistula) in the hemodialysis population; and (5) a feasible and safe trial design. The results obtained from this vanguard phase of the RCT will determine the feasibility and safety of conducting a large RCT, which will be powered for the primary outcome of days spent in hospital.

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 safety data exists for catheters and fistulas in hemodialysis for kidney failure?

Safety data indicates that non-tunneled catheters are associated with high rates of complications, particularly infections and bleeding, with infections often leading to severe outcomes like sepsis and even death. Tunneled catheters, while used as an alternative when arteriovenous fistulas (AVF) are not viable, also carry risks such as poor performance and complications like 'embedded' catheters, which can lead to serious health issues. In contrast, AVFs are generally associated with fewer complications, although patient satisfaction and other factors may influence the choice of vascular access. ^{1 2 3 4 5}

Is the treatment Catheter a promising treatment for hemodialysis in kidney failure?

Catheters can be a useful treatment for hemodialysis when other options like fistulas are not available or ready. They are especially helpful for urgent situations where immediate dialysis is needed. Catheters allow patients to start treatment quickly and can be a temporary solution while waiting for a more permanent access like a fistula to be ready. ^{3 4 6 7 8}

What data supports the idea that Catheter vs Fistula for Hemodialysis in Kidney Failure is an effective treatment?

The available research shows that while catheters are often used for hemodialysis, they come with a higher risk of complications compared to fistulas. Catheters are sometimes necessary when a fistula cannot be used, such as when a fistula is not ready or in emergency situations. However, the research indicates that fistulas are generally preferred due to fewer complications. Despite this, catheters are still widely used, possibly due to patient satisfaction or immediate need. Overall, the data suggests that while catheters can be effective in certain situations, fistulas are generally more effective for long-term use. ^{3 4 6 9 10}

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 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 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]

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]

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]

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]

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]

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

The Vascular Access Questionnaire: assessing patient-reported views of vascular access. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Tunneled catheters in hemodialysis: Indications and complications. [2022]

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

Complications of catheters: tunneled and nontunneled. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Potentially fatal atrium perforation due to right jugular vein catheterization recognized by venography: A case report. [2023]

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

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

6. Australia 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. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Endoluminal dilatation technique to remove stuck hemodialysis tunneled catheter: A case report from Indonesia. [2021]

8. Switzerland 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. [2023]

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

Using tunneled femoral vein catheters for "urgent start" dialysis patients: a preliminary report. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Timing of Fistula Creation and the Probability of Catheter-Free Use: A Cohort Study. [2022]