Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

June 17, 2015 updated by: Jo-Anne Wilson, Nova Scotia Health Authority

Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase

Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, b3h 2y9
        • Capital Health District Authority, Department of Medicine, Division of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.

Exclusion Criteria:

  • Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA.
  • A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria:
  • CVC line insertion or exchange within 72 hours;
  • any surgery, organ biopsy, obstetrical delivery within 72 hours;
  • active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks;
  • active pericarditis; arterial puncture within 48 hours;
  • bacteremia with positive blood cultures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
Drug: Alteplase
Alteplase for CVC dysfunction.
Other Names:
  • rt-PA
  • Cathflo
Experimental: Standard
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
Drug: Alteplase
Alteplase for CVC dysfunction.
Other Names:
  • rt-PA
  • Cathflo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alteplase use
Time Frame: 9 months
Incident rate of rt-PA uses includes the numerator which will consist of the number of HD sessions during which a patient was administered rt-PA for catheter malfunction and the denominator will be the time period at risk in catheter days.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of bacteremia
Time Frame: 9 months
Rate of bacteremia will include the numberator which will consit of the number of definite or probable catheter related bacteremia events and the decominator will be the time period at risk in catheter days.
9 months
Cost of alteplase
Time Frame: 9 months
Cost of rt-PA will be calculated per TLD for the study period.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Jo-Anne S Wilson, PharmD, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

June 18, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dialysis Catheter Protcols

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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