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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Taurolidine-citrate, heparin |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/11/2006 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 patients per group (total: 100 patients) |
| 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
- England
- United Kingdom
Study participating centre
Renal Unit
Preston
PR2 9HT
United Kingdom
PR2 9HT
United Kingdom
Sponsor information
Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Sharoe Green Lane
Preston
PR2 9HT
England
United Kingdom
| Phone | +44 (0)1772 716565 |
|---|---|
| laurie.solomon@lthtr.nhs.uk | |
| Website | http://www.lancsteachinghospitals.nhs.uk/ |
"ROR" |
https://ror.org/02j7n9748 |
Funders
Funder type
Government
Lancashire Teaching Hospitals NHS Foundation Trust (UK) - internal funding
No information available
Central Manchester University Hospitals NHS Foundation Trust (UK) - internal funding
No information available
Royal Liverpool Hospital NHS Trust (UK) - internal funding
No information available
North West Kidney Research Association (UK) - small grant from the Preston Branch
No information available
Liverpool Regional Dialysis Unit Fund (UK) - small grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
