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

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ClinicalTrials.gov Identifier: NCT02675569
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Applied Health Research Centre
Information provided by (Responsible Party):
Dr. Rob Quinn, University of Calgary

Brief Summary:
This pilot 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 this pilot 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 pilot RCT will determine the feasibility and safety of conducting a large RCT, which will be powered for the primary outcome of all-cause mortality.

Condition or disease Intervention/treatment Phase
End-stage Kidney Failure Procedure: Catheter Procedure: Fistula Not Applicable

Detailed Description:

Purpose: This pilot 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 pilot 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 pilot 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 36 months. All screened people 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). Every consented participant will have the following additional data collected at baseline: baseline laboratory values, baseline hemodialysis initiation, history of access procedures, patient-reported outcome measures (includes data on quality of life and a vascular access questionnaire), and grip strength. The pilot 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 pilot RCT, and to prepare and submit funding applications for the large RCT. Participants in the pilot RCT will be rolled into the large RCT, and will therefore be followed for a total of 36 months (3 years) after randomization to assess adherence to the trial protocol, assess safety outcomes, and collect qualitative data.

Statistical Analysis Plan: The primary analysis of the pilot 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 pilot 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACCESS HD Pilot: A Randomized Trial Comparing Catheters to Fistulas in Elderly patientS Starting HemoDialysis
Study Start Date : May 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

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.




Primary Outcome Measures :
  1. Feasibility; proportion of eligible people who are randomized (at least 25%) [ Time Frame: 42 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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).

  2. Descriptive; reasons that people decline to participate (feasibility) [ Time Frame: 42 months ]
    Investigators will consider the reasons that people decline to participate.

  3. 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.

  4. 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).

  5. 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.

  6. Number of drop-ins [ Time Frame: 42 months ]
    Investigators will collect the number and reasons for drop-ins and drop-outs.

  7. Number of drop-outs [ Time Frame: 42 months ]
    Investigators will collect the number and reasons for drop-ins and drop-outs.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients age ≥ 55;
  2. Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access;
  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 for at least 6 months.

Exclusion Criteria:

  1. Started hemodialysis with a fistula or have a patent fistula already in place;
  2. . Has had a prior arteriovenous graft creation;
  3. Imminent transplant planned (within 6 months, must be booked);
  4. Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675569


Contacts
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Contact: Daniel Jin 416-864-6060 ext 77072 JinD@smh.ca
Contact: Sharon Gulewich 403-955-6387 Sharon.Gulewich@albertahealthservices.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2R 0X7
Contact: Rob Quinn       rrquinn@gmail.com   
Contact: Sharon Gulewich       Sharon.Gulewich@albertahealthservices.ca   
Principal Investigator: Rob Quinn         
Principal Investigator: Pietro Ravani         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Robert Pauly         
Principal Investigator: Robert Pauly         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Lisa Miller         
Principal Investigator: Lisa Miller         
Canada, Newfoundland and Labrador
Memorial University of Newfoundland Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Brendan Barrett         
Principal Investigator: Brendan Barrett         
Canada, Ontario
St. Joseph's Hospital Withdrawn
Hamilton, Ontario, Canada, L8N 4A6
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A 5W9
Contact: Louise Moist         
Principal Investigator: Louise Moist         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 7W9
Contact: Swapnil Hiremath         
Principal Investigator: Swapnil Hiremath         
Humber River Hospital Recruiting
Toronto, Ontario, Canada, M3M 0B2
Contact: Gihad Nesrallah         
Principal Investigator: Gihad Nesrallah         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Matthew Oliver         
Principal Investigator: Matthew Oliver         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ron Wald         
Principal Investigator: Ron Wald         
Sponsors and Collaborators
University of Calgary
Applied Health Research Centre
Investigators
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Principal Investigator: Rob Quinn, PhD University of Calgary
Principal Investigator: Pietro Ravani, PhD University of Calgary
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Rob Quinn, Nephrologist and Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02675569    
Other Study ID Numbers: REB14-1670
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Rob Quinn, University of Calgary:
Vascular access
Hemodialysis
Kidney failure
Catheter
Fistula
Additional relevant MeSH terms:
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Renal Insufficiency
Fistula
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases