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Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

N

Nova Scotia Health Authority (NSHA)

Status

Completed

Conditions

Chronic Renal Insufficiency

Treatments

Drug: Alteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT02474810
Dialysis Catheter Protcols

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Intensive
Experimental group
Description:
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
Treatment:
Drug: Alteplase
Standard
Experimental group
Description:
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
Treatment:
Drug: Alteplase

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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