Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

Phase 2

Terminated

• Conditions: Hemodialysis
• Interventions: Other: Protocolized approach to convert dialysis catheter to fistula

• Registration Number: NCT01053117
• Lead Sponsor: Dr. Lisa Miller

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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocolized approach	Protocolized approach to convert dialysis catheter to fistula	Protocolized approach to convert catheter to arteriovenous fistula

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of patients with a maturing AVF	9 months
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
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

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada