Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Unknown status

CT.gov ID

NCT02474810

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Insufficiency	Drug: Alteplase	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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: Cathflo rt-PA
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: Cathflo rt-PA

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:

Cathflo

rt-PA

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:

Cathflo

rt-PA

Outcome Measures

Primary Outcome Measures

Alteplase use [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.

Secondary Outcome Measures

Rate of bacteremia [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.
Cost of alteplase [9 months]
Cost of rt-PA will be calculated per TLD for the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.