ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis
End-stage Kidney FailureThis 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
55 and up
Participation Criteria
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;
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 Location
University of Manitoba
University of ManitobaWinnipeg, Manitoba
Canada
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The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Memorial University of Newfoundland
Memorial University of NewfoundlandSt. John's, Newfoundland and Labrador
Canada
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Humber River Hospital
Humber River HospitalToronto, Ontario
Canada
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University of Calgary
University of CalgaryCalgary, Alberta
Canada
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St. Joseph's Hospital
St. Joseph's HospitalHamilton, Ontario
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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- Study Sponsored By
- University of Calgary
- Participants Required
- More Information
- Study ID:
NCT02675569