Alteplase v.s. Trisodium Citrate and Infection and Obstruction Incidence of Permanent Tunneled Dialysis Catheters

The incidence of infection and obstruction of newly inserted permanent tunneled dialysis catheters in chronic hemodialysis patients with using alteplase or trisodium citrate as a locking solution after the middle hemodialysis procedure.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000152820

Acronym

ACIP Study

Enrollment

Registered

2012-02-03

Start date

2012-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to test the hypothesis that the application of alteplasis as a locking solution for tunneled dialysis permanent catheter once a week will decrease the incidence of catheter related blood stream infection and will influence the incidence of catheter obstruction/malfunction.

Interventions

1mg of alteplase per lumen as a locking solution for permanent tunneled dialysis catheter once a week during the whole interdialysis interval (between dialysis procedure No. 2 and 3). Alteplase (1mg/1ml) will be administred into each lumen initially and then follow by saline at a volume adequate to fill the entire luminal volume (declared by manufacturer on each lumen of catheter).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with end stage kidney disease and newly inserted permanent tunneled dialysis catheter. Dialysis prescription = 3 times a week. Agreement with the trial participation.

Exclusion criteria

- anticoagulation treatment INR more than 1.4 - platelets count less than 60x109/l - catheter insertion in vena cava inferior region (femoral vein) - catheter insertion by a guide-wire exchange procedure - active pericarditis with pericardial effusion - known allergy or intolerance to alteplase or trisodium - citrate pregnancy or breast-feeding

Outcome results