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
|Condition or disease||Intervention/treatment||Phase|
|End-stage Kidney Failure||Procedure: Catheter Procedure: Fistula||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
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.
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
- Feasibility; proportion of eligible people who are randomized (at least 25%) [ Time Frame: 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 ]
- 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).
- Descriptive; reasons that people decline to participate (feasibility) [ Time Frame: 42 months ]Investigators will consider the reasons that people decline to participate.
- 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.
- 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).
- 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.
- Number of drop-ins [ Time Frame: 42 months ]Investigators will collect the number and reasons for drop-ins and drop-outs.
- Number of drop-outs [ Time Frame: 42 months ]Investigators will collect the number and reasons for drop-ins and drop-outs.
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
|Contact: Daniel Jin||416-864-6060 ext 77072||JinD@smh.ca|
|Contact: Sharon Gulewich||403-955-6387||Sharon.Gulewich@albertahealthservices.ca|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2R 0X7|
|Contact: Rob Quinn email@example.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|
|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|
|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|
|Principal Investigator:||Rob Quinn, PhD||University of Calgary|
|Principal Investigator:||Pietro Ravani, PhD||University of Calgary|