Contact information
Type
Scientific
Primary contact
Dr Laurence Solomon
ORCID ID
Contact details
Renal Unit
Royal Preston Hospital
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
+44 (0)1772 522750
laurie.solomon@lthtr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Cumbria and Lancashire B Research Ethics committee approved on the 4th July 2006 (ref: 06/Q1309/30)
Study design
Randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Taurolidine-citrate, heparin
Primary outcome measures
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 trial start date
01/11/2006
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients per group (total: 100 patients)
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
30/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit
Preston
PR2 9HT
United Kingdom
Sponsor information
Organisation
Lancashire Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
Sharoe Green Lane
Preston
PR2 9HT
United Kingdom
+44 (0)1772 716565
laurie.solomon@lthtr.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Lancashire Teaching Hospitals NHS Foundation Trust (UK) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Central Manchester University Hospitals NHS Foundation Trust (UK) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Liverpool Hospital NHS Trust (UK) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
North West Kidney Research Association (UK) - small grant from the Preston Branch
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Liverpool Regional Dialysis Unit Fund (UK) - small grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20207458
Publication citations
-
Results
Solomon LR, Cheesbrough JS, Ebah L, Al-Sayed T, Heap M, Millband N, Waterhouse D, Mitra S, Curry A, Saxena R, Bhat R, Schulz M, Diggle P, A randomized double-blind controlled trial of taurolidine-citrate catheter locks for the prevention of bacteremia in patients treated with hemodialysis., Am. J. Kidney Dis., 2010, 55, 6, 1060-1068, doi: 10.1053/j.ajkd.2009.11.025.