Double-blind clinical trial of taurolidine-citrate for the prevention of infection in patients using tunnelled lines for haemodialysis
Completed
- Conditions
- Catheter-related bacteraemiaInfections and InfestationsOther septicaemia
- Registration Number
- ISRCTN51902376
- Lead Sponsor
- ancashire Teaching Hospitals NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Adult patients (aged greater than 18 years), either sex
2. Requirement for dialysis using a tunnelled dialysis line
3. Able to give informed consent
Exclusion Criteria
1. Children aged less than 18 years
2. Unable to give informed consent
3. Positive blood culture in previous seven days
4. Unstable bleeding diathesis or hypercoagulable state
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 'Intention to treat' analysis of symptomatic and asymptomatic bacteraemic episodes. A bacteraemic episode will be defined by a single positive blood culture. Symptoms will be judged clinically on the basis of fever or rigors associated with dialysis. Measured by a positive blood culture at the time when the patient has relevant symptoms<br>2. A comparison of the unassisted line patency rate between the two treatment groups. This will be based on the need for thrombolytic therapy or radiological intervention. Detected by a requirement to use of thrombolytic therapy and the date when this happened.
- Secondary Outcome Measures
Name Time Method 1. The type of bacterium, outcome of treatment with antibiotics and relapse rate in those patients with proven infection<br>2. C-reactive protein concentrations<br>3. Haemoglobin concentrations, measured monthly <br>4. Erythropoietin requirement, recorded every two weeks <br>5. Blood flows, recorded every two weeks <br>6. Electron microscopy of removed lines to look for Biofilm