Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients

Phase 2TerminatedNCT01053117

Dr. Lisa Miller3 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemodialysis

Interventions

Protocolized approach to convert dialysis catheter to fistulaOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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 Outcomes

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

Proportion of patients with a maturing AVF

Time frame: 9 months

Primary fistula failure rate

Time frame: 9 months

Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation

Time frame: 9 months

Data from ClinicalTrials.gov

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