Role of antibiotic line locks in the prevention of tunnelled haemodialysis catheter infection: a double blind randomised controlled trial. - Prevention of infection in haemodialysis catheters
- Conditions
- Tunnelled haemodialysis catheter related infection. These infections are common (approximately 2-7 infections per 1000 catheter days) in patients on haemodialysiswe aim to assess the efficacy of an antibiotic line lock solution in reducing their incidence.
- Registration Number
- EUCTR2005-003148-79-GB
- Lead Sponsor
- Wirral Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
All incident patients requiring insertion of a tunnelled haemodialysis line for haemodialysis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Pateints on prolonged courses of antibiotics (oral or parenteral) i.e. for greater than 2 weeks.
2. Patients with a known allergy to vancomycin or gentamicin.
3. Patients known to suffer from heparin induced thrombocytopenia.
4. Patients who are pregnant or plan to become pregnant.
5. An inability to provide informed consent to participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether the use of the antibiotic line lock solution from catheter insertion is associated with a reduction in catheter related infection. The primary outcome measure is time in days to catheter related infection.;Secondary Objective: To assess the effects of this intervention on serum albumin, haemoglobin, erythropoietin requirements and hospital admissions.;Primary end point(s): Time in days from insertion of tunnelled haemodialysis catheter to first catheter related infection.
- Secondary Outcome Measures
Name Time Method