End-stage Kidney Failure
Conditions
Keywords
Vascular access, Hemodialysis, Kidney failure, Catheter, Fistula
Brief summary
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.
Detailed description
Purpose: This vanguard phase of the RCT will help to address challenges related to patient recruitment, protocol adherence, safety, and data collection in the hemodialysis population. The primary outcome for this vanguard phase of the RCT is feasibility, which will be measured by patient recruitment and protocol adherence. The secondary outcomes include feasibility-related outcomes, safety (which will include expected procedure-related outcomes and causes for hospital admissions), and other protocol violations. Hypothesis: Results obtained from the vanguard phase of the RCT will provide feasibility and safety data for conducting a large RCT, which will establish a better understanding of the clinical outcomes associated with the use of fistula versus catheter for vascular access in the hemodialysis population. Research Method: This is a multicenter, open-label, RCT, and is expected to be conducted over 24 months. All consented and enrolled participants who meet the eligibility criteria will have the following data collected in a minimal dataset: eligibility, age, sex, program/center, height, weight, comorbid conditions, and details of any prior treatment for acute or chronic kidney failure (e.g., previous peritoneal dialysis, kidney transplant, or hemodialysis). The following additional data will be collected at baseline: baseline laboratory values, baseline hemodialysis initiation, history of access procedures, and patient-reported outcome measures (includes data on quality of life and a vascular access questionnaire). The vanguard phase of the RCT will consist of 6 months of site preparation, approximately 24 months of participant accrual, and 6 months of additional follow-up time for the last randomized participant. An additional 6 months will be used to assess the preliminary data, prepare the report of this vanguard phase of the RCT, and to prepare and submit funding applications for the large RCT. Participants in the vanguard phase of the RCT will be rolled into the large RCT, and will therefore be followed for a total of 24 months (2 years) in Canada and a total of 36 months (3 years) in Australia after randomization to assess adherence to the trial protocol, assess safety outcomes, and collect qualitative data. Statistical Analysis Plan: The primary analysis of the vanguard phase of the RCT will be descriptive. The proportion of people meeting each of the feasibility endpoints with accompanying 95% confidence intervals will be calculated. Investigators will describe participant characteristics and evaluate reasons for protocol violation, as well as calculate rates of drop-ins and other events. Interim or subgroup analyses will not be conducted in this vanguard phase of the RCT. Expected Procedure-Related Outcomes (Safety Data): As both catheter and fistula treatment strategies are standard of care, the procedure-related outcomes are well known. Investigators will collect only expected procedure-related outcomes (i.e., events that have a potentially causal relationship to the strategy) that occur within 7 days of the execution of any access related intervention. These will include hospital admissions and prolongation of hospitalization, status changes, bacterial infections, catheter or exit site infections, cannulation injury events. In addition, sites will report all incidents of participant death that occur during the trial period. Cause of death will be determined by trial site investigators, based on a trial-specific list of classifications, and will be adjudicated for accuracy by appropriate members of the trial steering committee, who will be blinded to treatment arm.
Interventions
PROCEDURECatheter
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
PROCEDUREFistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
Sponsors
Applied Health Research Centre
The George Institute
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients age ≥ 55; (AUS sites : adult patients age ≥ 65); 2. a). Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access AND ≤ 1 previously unsuccessful fistula attempt; OR b).Changing over from peritoneal dialysis AND no functioning arteriovenous fistula available at HD start; 3. Treated with hemodialysis for 365 days or less at the time of consent (374 days or less at the time of randomization); 4. Clinically and cognitively stable (able to provide consent within 365 days of hemodialysis start); 5. Hemodialysis is the intended modality of treatment; 6. End-stage (permanent) kidney failure unlikely to recover kidney function according to the attending nephrologist; 7. Eligible for a fistula attempt as determined by the local multidisciplinary access team; 8. Planning to remain in the current dialysis center/service for at least 6 months;
Exclusion criteria
1. Started hemodialysis with a fistula or have a patent fistula already in place or had \>1 unsuccessful attempt; (AUS sites: or previously functioning fistula no longer working); 2. . Has had a prior arteriovenous graft creation; 3. Imminent transplant planned (within 6 months); 4. Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility; proportion of eligible people who are randomized (at least 25%) | 42 months |
| Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%) | 42 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility) | 42 months | Investigators will consider the reasons that people are considered ineligible for a fistula attempt. |
| Descriptive; reasons for delayed access to fistula surgery (feasibility) | 42 months | Investigators will consider the reasons for delayed access to fistula surgery (\> 90 days from randomization). |
| Descriptive; reasons for exclusion of all screened participants (feasibility) | 42 months | Investigators will consider the reasons for exclusion of screened participants (including competing studies). |
| Number of drop-ins | 42 months | Investigators will collect the number and reasons for drop-ins and drop-outs. |
| Number of drop-outs | 42 months | Investigators will collect the number and reasons for drop-ins and drop-outs. |
| Safety; expected procedure-related outcomes for both catheter and fistula treatment strategies that occur within 7 days of the execution of any access related intervention | 7 days | Investigators will collect information on expected procedure-related outcomes for both catheter and fistula treatment strategies that occur within 7 days of the execution of any access related intervention. Additionally, coordinators will track causes for hospital admissions and prolongation of hospitalization, and sites will report all incidents of participant death that occur during the trial period to identify if outcomes may have resulted from the trial procedures. |
| Descriptive; reasons that people decline to participate (feasibility) | 42 months | Investigators will consider the reasons that people decline to participate. |
Countries
Australia, Canada
Contacts
Primary ContactSorcha Mulligan
Backup ContactSharon Gulewich
Outcome results
None listed