Recruiting

Catheters vs. Fistulas

Sponsor:

University of Calgary

Code:

NCT02675569

Conditions

End-stage Kidney Failure

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Catheter

Fistula

Study Details

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.

Conditions

End-stage Kidney Failure

Study ID

NCT02675569

Start date

May, 2016

Status verified date

Jul, 2022

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2R 0X7

Contacts

Principal Investigator:

Rob Quinn

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Contacts

Principal Investigator:

Swapnil Hiremath

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Matthew Oliver

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Principal Investigator:

Ron Wald

More Information

Sponsor

University of Calgary

Last update posted

Jul 21, 2022

Last verified

Jul, 2022

Keywords

  • Vascular access
  • Hemodialysis
  • Kidney failure
  • Catheter
  • Fistula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-07-21.