Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

NCT01053117 | Terminated Phase 2

• 1 other identifier: B2008:101
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Keywords

central venous catheter; arteriovenous fistula; hemodialysis; vascular access; dialysis

Outcome Measures

Primary Outcomes (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.

  9 months

Secondary Outcomes (4)

• 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

• Proportion of patients with a maturing AVF

  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 Arms (2)

Protocolized approach

EXPERIMENTAL

Protocolized approach to convert catheter to arteriovenous fistula

Other: Protocolized approach to convert dialysis catheter to fistula

Current Care Model

NO INTERVENTION

Interventions

Protocolized approach to convert dialysis catheter to fistula OTHER

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

Protocolized approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lisa Miller: lead
• Health Sciences Centre Foundation, Manitoba: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa M Miller, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Lisa Miller

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: February 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

CA (1)