We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01053117
Recruitment Status : Terminated (Unable to enrol patients)
First Posted : January 21, 2010
Last Update Posted : April 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hemodialysis Other: Protocolized approach to convert dialysis catheter to fistula Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial
Study Start Date : February 2009
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Proportion of patients with a maturing AVF [ Time Frame: 9 months ]
  3. Primary fistula failure rate [ Time Frame: 9 months ]
  4. Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Lisa Miller, University of Manitoba
ClinicalTrials.gov Identifier: NCT01053117     History of Changes
Other Study ID Numbers: B2008:101
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by Dr. Lisa Miller, University of Manitoba:
central venous catheter
arteriovenous fistula
hemodialysis
vascular access
dialysis