Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Renal Insufficiency

Intervention / Treatment
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* Drug: Alteplase


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 
| Cost of alteplase | Cost of rt-PA will be calculated per TLD for the study period. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheters, hemodialysis, thrombosis, tissue plasminogen activator