ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
NCT ID: NCT02675569
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-05-31
2025-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Catheter
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
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.
Fistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
Interventions
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Catheter
A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
Fistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
Eligibility Criteria
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Inclusion Criteria
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
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;
55 Years
ALL
No
Sponsors
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Applied Health Research Centre
OTHER
The George Institute
OTHER
University of Calgary
OTHER
Responsible Party
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Dr. Rob Quinn
Nephrologist and Associate Professor
Principal Investigators
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Rob Quinn, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Pietro Ravani, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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The Canberra Hospital
Garran, Australian Capital Territory, Australia
Illawarra Shoalhaven Local Health District (ISLHD)
Wollongong, New South Wales, Australia
Sunshine Coast Hospital and Health Service (SCHHS)
Birtinya, Queensland, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Lee H, Manns B, Taub K, Ghali WA, Dean S, Johnson D, Donaldson C. Cost analysis of ongoing care of patients with end-stage renal disease: the impact of dialysis modality and dialysis access. Am J Kidney Dis. 2002 Sep;40(3):611-22. doi: 10.1053/ajkd.2002.34924.
Jindal K, Chan CT, Deziel C, Hirsch D, Soroka SD, Tonelli M, Culleton BF; Canadian Society of Nephrology Committee for Clinical Practice Guidelines. Hemodialysis clinical practice guidelines for the Canadian Society of Nephrology. J Am Soc Nephrol. 2006 Mar;17(3 Suppl 1):S1-27. doi: 10.1681/ASN.2005121372. No abstract available.
Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, Pannu NI, Thomas C, Hemmelgarn BR, Craig JC, Manns B, Tonelli M, Strippoli GF, James MT. Associations between hemodialysis access type and clinical outcomes: a systematic review. J Am Soc Nephrol. 2013 Feb;24(3):465-73. doi: 10.1681/ASN.2012070643. Epub 2013 Feb 21.
Quinn RR, Laupacis A, Hux JE, Oliver MJ, Austin PC. Predicting the risk of 1-year mortality in incident dialysis patients: accounting for case-mix severity in studies using administrative data. Med Care. 2011 Mar;49(3):257-66. doi: 10.1097/MLR.0b013e318202aa0b.
Tennankore KK, Soroka SD, Kiberd BA. The impact of an "acute dialysis start" on the mortality attributed to the use of central venous catheters: a retrospective cohort study. BMC Nephrol. 2012 Jul 30;13:72. doi: 10.1186/1471-2369-13-72.
Mazonakis E, Stirling C, Booth KL, McClenahan J, Heron N, Geddes CC. The influence of comorbidity on the risk of access-related bacteremia in chronic hemodialysis patients. Hemodial Int. 2009 Jan;13(1):6-10. doi: 10.1111/j.1542-4758.2009.00327.x.
Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol. 2006 Nov;17(11):3204-12. doi: 10.1681/ASN.2006030190. Epub 2006 Sep 20.
Quinn RR, Lamping DL, Lok CE, Meyer RA, Hiller JA, Lee J, Richardson EP, Kiss A, Oliver MJ. The Vascular Access Questionnaire: assessing patient-reported views of vascular access. J Vasc Access. 2008 Apr-Jun;9(2):122-8.
Oliver MJ, Verrelli M, Zacharias JM, Blake PG, Garg AX, Johnson JF, Pandeya S, Perl J, Kiss AJ, Quinn RR. Choosing peritoneal dialysis reduces the risk of invasive access interventions. Nephrol Dial Transplant. 2012 Feb;27(2):810-6. doi: 10.1093/ndt/gfr289. Epub 2011 Jun 21.
Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.
Casey JR, Hanson CS, Winkelmayer WC, Craig JC, Palmer S, Strippoli GF, Tong A. Patients' perspectives on hemodialysis vascular access: a systematic review of qualitative studies. Am J Kidney Dis. 2014 Dec;64(6):937-53. doi: 10.1053/j.ajkd.2014.06.024. Epub 2014 Aug 10.
Detry MA, Lewis RJ. The intention-to-treat principle: how to assess the true effect of choosing a medical treatment. JAMA. 2014 Jul 2;312(1):85-6. doi: 10.1001/jama.2014.7523. No abstract available.
Murea M, James KM, Russell GB, Byrum GV 3rd, Yates JE, Tuttle NS, Bleyer AJ, Burkart JM, Freedman BI. Risk of catheter-related bloodstream infection in elderly patients on hemodialysis. Clin J Am Soc Nephrol. 2014 Apr;9(4):764-70. doi: 10.2215/CJN.07710713. Epub 2014 Mar 20.
Quinn R, Ravani P; ACCESS HD Investigators. ACCESS HD pilot: A randomised feasibility trial Comparing Catheters with fistulas in Elderly patientS Starting haemodialysis. BMJ Open. 2016 Nov 24;6(11):e013081. doi: 10.1136/bmjopen-2016-013081.
Other Identifiers
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REB14-1670
Identifier Type: -
Identifier Source: org_study_id
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