ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis (ACCESS HD)

July 18, 2022 updated by: Dr. Rob Quinn, University of Calgary

ACCESS HD Pilot: A Randomized Trial Comparing Catheters to Fistulas in Elderly patientS Starting HemoDialysis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Not yet recruiting
        • The Canberra Hospital
        • Contact:
        • Principal Investigator:
          • Girish Talaulikar
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast Hospital and Health Service (SCHHS)
        • Contact:
        • Principal Investigator:
          • Nicholas Gray
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 0X7
      • Edmonton, Alberta, Canada, T6G 2G3
        • Active, not recruiting
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Completed
        • University of Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Completed
        • Memorial University of Newfoundland
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Withdrawn
        • St. Joseph's Hospital
      • London, Ontario, Canada, N6A 5W9
        • Withdrawn
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 7W9
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Swapnil Hiremath
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ron Wald
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M3M 0B2
        • Completed
        • Humber River Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Catheter
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.
Procedure: Catheter
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
EXPERIMENTAL: Fistula
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.
Procedure: Fistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility; proportion of eligible people who are randomized (at least 25%)
Time Frame: 42 months
42 months
Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)
Time Frame: 42 months
42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive; reasons for exclusion of all screened participants (feasibility)
Time Frame: 42 months
Investigators will consider the reasons for exclusion of screened participants (including competing studies).
42 months
Descriptive; reasons that people decline to participate (feasibility)
Time Frame: 42 months
Investigators will consider the reasons that people decline to participate.
42 months
Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)
Time Frame: 42 months
Investigators will consider the reasons that people are considered ineligible for a fistula attempt.
42 months
Descriptive; reasons for delayed access to fistula surgery (feasibility)
Time Frame: 42 months
Investigators will consider the reasons for delayed access to fistula surgery (> 90 days from randomization).
42 months
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
Time Frame: 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.
7 days
Number of drop-ins
Time Frame: 42 months
Investigators will collect the number and reasons for drop-ins and drop-outs.
42 months
Number of drop-outs
Time Frame: 42 months
Investigators will collect the number and reasons for drop-ins and drop-outs.
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

The George Institute
Applied Health Research Centre

Investigators

  • Principal Investigator: Rob Quinn, PhD, University of Calgary
  • Principal Investigator: Pietro Ravani, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (ESTIMATE)

February 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB14-1670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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