Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Manitoba.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Manitoba
Collaborator:
Health Sciences Centre Foundation, Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01053117
First received: January 19, 2010
Last updated: January 25, 2010
Last verified: January 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hemodialysis |
Other: Protocolized approach to convert dialysis catheter to fistula |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial |
Resource links provided by NLM:
Further study details as provided by University of Manitoba:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Proportion of patients with a maturing AVF [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Primary fistula failure rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053117
Contacts
| Contact: Lisa M Miller, MD | (204) 787-1524 | lmiller@hsc.mb.ca |
Locations
| Canada, Manitoba | |
| Health Sciences Centre | Recruiting |
| Winnipeg, Manitoba, Canada, R3A1R9 | |
| Principal Investigator: Lisa M Miller, MD | |
Sponsors and Collaborators
University of Manitoba
Health Sciences Centre Foundation, Manitoba
Investigators
| Principal Investigator: | Lisa M Miller, MD | University of Manitoba |
More Information
No publications provided
| Responsible Party: | Dr. Lisa Miller, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT01053117 History of Changes |
| Other Study ID Numbers: | B2008:101 |
| Study First Received: | January 19, 2010 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Manitoba:
|
central venous catheter arteriovenous fistula hemodialysis vascular access dialysis |
ClinicalTrials.gov processed this record on May 23, 2013