Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01053117
• Other study ID #: B2008:101
• Status: Terminated
• Phase: Phase 2
• First received: January 19, 2010
• Last updated: April 16, 2014
• Start date: February 2009
• Est. completion date: August 2012

Study information

• Verified date: April 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis

Intervention

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

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Lisa Miller	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Proportion of patients with a maturing AVF		9 months	No
Secondary	Primary fistula failure rate		9 months	No
Secondary	Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation		9 months	No