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

NCT02675569 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-21

No results posted yet for this study

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

Interventions

PROCEDURE

Catheter

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

PROCEDURE

Fistula

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

Sponsors & Collaborators

  • Applied Health Research Centre

    collaborator OTHER

  • The George Institute

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Rob Quinn, PhD · University of Calgary

  • Pietro Ravani, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675569 on ClinicalTrials.gov