Double-blind clinical trial of taurolidine-citrate for the prevention of infection in patients using tunnelled lines for haemodialysis
| ISRCTN | ISRCTN51902376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51902376 |
| Protocol serial number | N/A |
| Sponsor | Lancashire Teaching Hospitals NHS Foundation Trust (UK) |
| Funders | Lancashire Teaching Hospitals NHS Foundation Trust (UK) - internal funding, Central Manchester University Hospitals NHS Foundation Trust (UK) - internal funding, Royal Liverpool Hospital NHS Trust (UK) - internal funding, North West Kidney Research Association (UK) - small grant from the Preston Branch, Liverpool Regional Dialysis Unit Fund (UK) - small grant |
- Submission date
- 09/08/2009
- Registration date
- 18/09/2009
- Last edited
- 28/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Laurence Solomon
Scientific
Scientific
Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
| Phone | +44 (0)1772 522750 |
|---|---|
| laurie.solomon@lthtr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Taurolidine-citrate catheter locks for the prevention of bacteraemia in patients using tunnelled intravascular catheters for haemodialysis: a randomised double-blind controlled trial |
| Study objectives | The primary aim of this study is to evaluate the feasibility, efficacy and cost-effectiveness of taurolidine line locks in the prevention of bacteraemia in haemodialysis patients using tunnelled lines starting at the time of line insertion and whether use of taurolidine from the time of line insertion is associated with an increased need for thrombolytic therapy. |
| Ethics approval(s) | Cumbria and Lancashire B Research Ethics committee approved on the 4th July 2006 (ref: 06/Q1309/30) |
| Health condition(s) or problem(s) studied | Catheter-related bacteraemia |
| Intervention | 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. Taurolidine will be supplied as 1.35% taurolidine and 4% citrate (TauroLock™, Tauropharm AG). Heparin will supplied as heparin sodium, Ph Eur (porcine) at 5000 IU/L with 1% benzylic acid as preservative (Braun AG). This trial will be completed six months after the recruitment of the last participant. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Taurolidine-citrate, heparin |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Renal Unit
Preston
PR2 9HT
United Kingdom
PR2 9HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
