Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Nova Scotia Health Authority35 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Renal Insufficiency

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 9 months

Secondary Outcomes

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.

Time frame: 9 months

Cost of alteplase

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

Time frame: 9 months

Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes