Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

This study has been terminated.
(Unable to enrol patients)
Sponsor:
Collaborator:
Health Sciences Centre Foundation, Manitoba
Information provided by (Responsible Party):
Dr. Lisa Miller, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01053117
First received: January 19, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hemodialysis
Other: Protocolized approach to convert dialysis catheter to fistula
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of patients with a maturing AVF [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Primary fistula failure rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: February 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protocolized approach
Protocolized approach to convert catheter to arteriovenous fistula
Other: Protocolized approach to convert dialysis catheter to fistula
This group will be assigned an algorithm protocol in efforts to convert the central venous catheter to an arteriovenous fistula. A case manager will be assigned to follow these patients and implement the protocol
No Intervention: Current Care Model

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053117

Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Sponsors and Collaborators
Dr. Lisa Miller
Health Sciences Centre Foundation, Manitoba
Investigators
Principal Investigator: Lisa M Miller, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Lisa Miller, University of Manitoba
ClinicalTrials.gov Identifier: NCT01053117     History of Changes
Other Study ID Numbers: B2008:101
Study First Received: January 19, 2010
Last Updated: April 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
central venous catheter
arteriovenous fistula
hemodialysis
vascular access
dialysis

ClinicalTrials.gov processed this record on October 23, 2014