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End-stage Kidney FailureACCESS HDNCT02675569

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

A study testing Catheter and Fistula in people with End-stage Kidney Failure, run by University of Calgary at 13 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
End-stage Kidney Failure
What is being tested?
Catheter and Fistula
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
13 sitesin 2 countries
Study dates
May 2016to Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients age ≥ 55; (AUS sites : adult patients age ≥ 65);
  • 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;
  • Treated with hemodialysis for 365 days or less at the time of consent (374 days or less at the time of randomization);
  • Clinically and cognitively stable (able to provide consent within 365 days of hemodialysis start);
  • Hemodialysis is the intended modality of treatment;
  • End-stage (permanent) kidney failure unlikely to recover kidney function according to the attending nephrologist;
  • Eligible for a fistula attempt as determined by the local multidisciplinary access team;
  • Planning to remain in the current dialysis center/service for at least 6 months;

Who cannot join

  • 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);
  • . Has had a prior arteriovenous graft creation;
  • Imminent transplant planned (within 6 months);
  • Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist;

Trial locations and contacts

13 sites in 2 countries.

Sorcha Mulligan contact

416-360-4000 ext. 77049

sorcha.mulligan@unityhealth.to

Sharon Gulewich contact

403-955-6387

Sharon.Gulewich@albertahealthservices.ca

13 sites in 2 countries

Canada10 sites, 4 recruiting

  • University of Calgary

    Calgary, Alberta, T2R 0X7

    Rob Quinn, rrquinn@gmail.com

    Sharon Gulewich, Sharon.Gulewich@albertahealthservices.ca

    Recruiting

  • University of Alberta

    Edmonton, Alberta, T6G 2G3

    Active, not recruiting

  • St. Joseph's Hospital

    Hamilton, Ontario, L8N 4A6

    Withdrawn

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Withdrawn

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 7W9

    Swapnil Hiremath, 613-738-8400 ext. 82762, shiremath@toh.on.ca

    Jennifer Biggs, jbiggs@ohri.ca

    Recruiting

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3V6

    Completed

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

    Completed

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Matthew Oliver, 416-480-6100 ext. 7061, matthew.oliver@sunnybrook.ca

    Amina Mahmood, 416-480-6100 ext. 1291, amina.mahmood@sri.utoronto.ca

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Ron Wald, 416-867-3703, waldr@smh.ca

    Ivana Prce, ivana.prce@unityhealth.to

    Recruiting

  • University of Manitoba

    Winnipeg, Manitoba, R3A 1R9

    Completed

Other trials in Canada

Australia3 sites, 3 recruiting

  • Sunshine Coast Hospital and Health Service (SCHHS)

    Birtinya, Queensland, 4575

    Nicholas Gray, 6175025876, nicholas.gray@health.qld.gov.au

    Nicholas Gray

    Recruiting

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

    Girish Talaulikar, 61251242821, girish.talaulikar@act.gov.au

    Girish Talaulikar

    Not yet recruiting

  • Illawarra Shoalhaven Local Health District (ISLHD)

    Wollongong, New South Wales, 2500

    Hicham Hassan, 61242275443, HichamIbrahim.CheikhHassan@health.nsw.gov.au

    Hicham Hassan

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
Catheter, Fistula
Keywords
Vascular access, Hemodialysis, Kidney failure, Catheter, Fistula
Medical subject headings
Renal Insufficiency, Chronic, Renal Insufficiency, Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CatheterProcedure or surgery

    A method of vascular access for hemodialysis that all participants will have in place prior to randomization.

  • FistulaProcedure or surgery

    A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.

Study groups in NCT02675569
Study groupRoleWhat they receive
CatheterActive comparatorCatheter is a method of vascular access for hemodialysis. It consists of a long, thin plastic tube and may be either tunnelled or non-tunnelled.
Receives: Procedure: Catheter
FistulaExperimentalFistula 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.
Receives: Procedure: Fistula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility; proportion of eligible people who are randomized (at least 25%)

    Measured: 42 months

  2. Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)

    Measured: 42 months

Secondary outcomes (7)

  1. Descriptive; reasons for exclusion of all screened participants (feasibility)

    Investigators will consider the reasons for exclusion of screened participants (including competing studies).

    Measured: 42 months

  2. Descriptive; reasons that people decline to participate (feasibility)

    Investigators will consider the reasons that people decline to participate.

    Measured: 42 months

  3. Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)

    Investigators will consider the reasons that people are considered ineligible for a fistula attempt.

    Measured: 42 months

  4. Descriptive; reasons for delayed access to fistula surgery (feasibility)

    Investigators will consider the reasons for delayed access to fistula surgery (> 90 days from randomization).

    Measured: 42 months

  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

    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.

    Measured: 7 days

  6. Number of drop-ins

    Investigators will collect the number and reasons for drop-ins and drop-outs.

    Measured: 42 months

  7. Number of drop-outs

    Investigators will collect the number and reasons for drop-ins and drop-outs.

    Measured: 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02675569
Sponsor's protocol ID
REB14-1670
Acronym
ACCESS HD
Status last verified
Jul 2022
First submitted
26 Jan 2016
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12200814

  • 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.

    PubMed 16497879

  • 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.

    PubMed 23431075

  • 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.

    PubMed 21301370

  • 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.

    PubMed 22846341

  • 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.

    PubMed 19210271

  • 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.

    PubMed 16988062

  • 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.

    PubMed 18609528

  • 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.

    PubMed 21693682

  • 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.

    PubMed 17507428

  • 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.

    PubMed 25115617

  • 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.

    PubMed 25058221

  • 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.

    PubMed 24651074

  • Quinn RR, Oliver MJ, Wald R, Hiremath S, Pauly RP, Miller L, Barrett B, Nesrallah G, Gallagher M, Kotwal S, Gray NA, Hassan HC, Talaulikar GS, Thorpe K, Graham J, Clarke A, Bian J, MacRae J, Santana M, Bohm C, Mamdani M, Nagpal S, Yilmaz S, Moist L, Ravani P. Comparing Catheters with Fistulas in Older Patients Starting Hemodialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2026 Jun 22. doi: 10.1681/ASN.0000001160. Online ahead of print.

    PubMed 42319856

  • 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.

    PubMed 27884849

Questions about this trial

What is this clinical trial studying?

A study testing Catheter and Fistula in people with End-stage Kidney Failure, run by University of Calgary at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sorcha Mulligan (416-360-4000 ext. 77049, sorcha.mulligan@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility; proportion of eligible people who are randomized (at least 25%) (time frame: 42 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02675569, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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