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Double-blind clinical trial of taurolidine-citrate for the prevention of infection in patients using tunnelled lines for haemodialysis

Taurolidine-citrate catheter locks for the prevention of bacteraemia in patients using tunnelled intravascular catheters for haemodialysis: a randomised double-blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51902376
Enrollment
100
Registered
2009-09-18
Start date
2006-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Catheter-related bacteraemia Infections and Infestations Other septicaemia

Interventions

Patients will randomised to receive either taurolidine-citrate or standard heparin (5000 IU/ml) line locks at the time of catheter insertion and after every dialysis until an end-point of the trial. T

Sponsors

Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 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

MeasureTime frame
1. The type of bacterium, outcome of treatment with antibiotics and relapse rate in those patients with proven infection 2. C-reactive protein concentrations 3. Haemoglobin concentrations, measured monthly 4. Erythropoietin requirement, recorded every two weeks 5. Blood flows, recorded every two weeks 6. Electron microscopy of removed lines to look for Biofilm

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026