Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

April 16, 2014 updated by: Dr. Lisa Miller

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
9 months
Proportion of patients with a maturing AVF
Time Frame: 9 months
9 months
Primary fistula failure rate
Time Frame: 9 months
9 months
Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lisa Miller

Collaborators

Health Sciences Centre Foundation, Manitoba

Investigators

  • Principal Investigator: Lisa M Miller, MD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B2008:101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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