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Clinical Trials/NCT01053117
NCT01053117
Terminated
Phase 2

Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial

Dr. Lisa Miller1 site in 1 country3 target enrollmentFebruary 2009
ConditionsHemodialysis

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hemodialysis
Sponsor
Dr. Lisa Miller
Enrollment
3
Locations
1
Primary Endpoint
The proportion of patients using a CVC in a prevalent hemodialysis population after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.
Status
Terminated
Last Updated
12 years ago

Overview

Brief Summary

To determine if a protocolized approach to converting hemodialysis central venous catheters (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.

Detailed Description

In order to receive dialysis, patients require repeated access to their bloodstream. This access can be either via a central venous catheter (CVC) or a surgically created arteriovenous fistula (AVF) or graft (AVG). This is a pilot randomized control trial of prevalent hemodialysis patients with a central venous catheter (CVC), to determine if a systematic approach using an algorithm protocol to convert the CVC to an AVF (arteriovenous fistula) will improve rates of functioning AVF and decrease CVC use. The algorithm (intervention group) will be compared to current practice (control group), a non-standardized approach at the discretion of the caring nephrologist and/or surgeon.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
August 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Lisa Miller
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Lisa Miller

Dr. Lisa Miller

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • \> 18 years of age
  • Dialyzing with a CVC
  • Receiving hemodialysis three times weekly for \> 3 months

Exclusion Criteria

  • Awaiting peritoneal dialysis catheter insertion
  • Scheduled living donor transplant
  • Transient patients from out of province
  • Expected transfer to satellite dialysis unit within 6 months
  • Surgical plan for AVF (i.e. scheduled date)
  • Documented lack of suitable vasculature for AVF
  • Refusing AVF

Outcomes

Primary Outcomes

The proportion of patients using a CVC in a prevalent hemodialysis population after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.

Time Frame: 9 months

Secondary Outcomes

  • Proportion of patients with a maturing AVF(9 months)
  • The proportion of patients with a functioning AVF after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.(9 months)
  • Primary fistula failure rate(9 months)
  • Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation(9 months)

Study Sites (1)

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