Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

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.

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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.

Conditions

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Chronic Renal Insufficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive

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

Group Type EXPERIMENTAL

Alteplase

Intervention Type DRUG

Alteplase for CVC dysfunction.

Standard

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

Group Type EXPERIMENTAL

Alteplase

Intervention Type DRUG

Alteplase for CVC dysfunction.

Interventions

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Alteplase

Alteplase for CVC dysfunction.

Intervention Type DRUG

Other Intervention Names

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Cathflo rt-PA

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No