Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Chronic Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02474810
• Other study ID #: Dialysis Catheter Protcols
• Status: Active, not recruiting
• Phase: N/A
• First received: June 16, 2015
• Last updated: June 17, 2015
• Start date: January 2013
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Alteplase
Alteplase for CVC dysfunction.

Locations

Country	Name	City	State
Canada	Capital Health District Authority, Department of Medicine, Division of Nephrology	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Cost of alteplase	Cost of rt-PA will be calculated per TLD for the study period.	9 months	No