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Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Primary Purpose

Chronic Renal Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alteplase
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Insufficiency focused on measuring central venous catheters, hemodialysis, thrombosis, tissue plasminogen activator

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Capital Health District Authority, Department of Medicine, Division of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intensive

Standard

Arm Description

In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal

In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.

Outcomes

Primary Outcome Measures

Alteplase use
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.

Secondary Outcome Measures

Rate of bacteremia
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.
Cost of alteplase
Cost of rt-PA will be calculated per TLD for the study period.

Full Information

First Posted
June 16, 2015
Last Updated
June 17, 2015
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02474810
Brief Title
Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol
Official Title
Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency
Keywords
central venous catheters, hemodialysis, thrombosis, tissue plasminogen activator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive
Arm Type
Experimental
Arm Description
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
Arm Title
Standard
Arm Type
Experimental
Arm Description
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
Cathflo, rt-PA
Intervention Description
Alteplase for CVC dysfunction.
Primary Outcome Measure Information:
Title
Alteplase use
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Rate of bacteremia
Description
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.
Time Frame
9 months
Title
Cost of alteplase
Description
Cost of rt-PA will be calculated per TLD for the study period.
Time Frame
9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo-Anne S Wilson, PharmD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health District Authority, Department of Medicine, Division of Nephrology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
b3h 2y9
Country
Canada

12. IPD Sharing Statement

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Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

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