Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02675569




Registration number
NCT02675569
Ethics application status
Date submitted
26/01/2016
Date registered
5/02/2016
Date last updated
21/07/2022

Titles & IDs
Public title
ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
Scientific title
ACCESS HD Pilot: A Randomized Trial Comparing Catheters to Fistulas in Elderly patientS Starting HemoDialysis
Secondary ID [1] 0 0
REB14-1670
Universal Trial Number (UTN)
Trial acronym
ACCESS HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Catheter
Treatment: Surgery - Fistula

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.

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.


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

Treatment: Surgery: Fistula
A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility; proportion of eligible people who are randomized (at least 25%)
Timepoint [1] 0 0
42 months
Primary outcome [2] 0 0
Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)
Timepoint [2] 0 0
42 months
Secondary outcome [1] 0 0
Descriptive; reasons for exclusion of all screened participants (feasibility)
Timepoint [1] 0 0
42 months
Secondary outcome [2] 0 0
Descriptive; reasons that people decline to participate (feasibility)
Timepoint [2] 0 0
42 months
Secondary outcome [3] 0 0
Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)
Timepoint [3] 0 0
42 months
Secondary outcome [4] 0 0
Descriptive; reasons for delayed access to fistula surgery (feasibility)
Timepoint [4] 0 0
42 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
7 days
Secondary outcome [6] 0 0
Number of drop-ins
Timepoint [6] 0 0
42 months
Secondary outcome [7] 0 0
Number of drop-outs
Timepoint [7] 0 0
42 months

Eligibility
Key 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;
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Illawarra Shoalhaven Local Health District (ISLHD) - Wollongong
Recruitment hospital [3] 0 0
Sunshine Coast Hospital and Health Service (SCHHS) - Birtinya
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University of Calgary
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Applied Health Research Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The George Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02675569
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Rob Quinn, PhD
Address 0 0
University of Calgary
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sorcha Mulligan
Address 0 0
Country 0 0
Phone 0 0
416-360-4000
Fax 0 0
Email 0 0
sorcha.mulligan@unityhealth.to
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02675569