Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
A new catheter-locking solution containing taurolodine and citrate has been shown to reduce catheter-related bacteraemia in small studies of mainly non-tunnelled catheters. We aim to test whether use of this solution will reduce the incidence of catheter-related bacteraemia in patients with tunnelled dialysis catheters.
Ethics approval
Medical Research Ethics Committee for Scotland A (reference: 06/MRE00/43), approval received 13/06/2006.
Study design
Interventional randomised double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic Renal Failure requiring treatment with regular haemodialysis
Intervention
One group will be randomised to receive taurolidine-citrate catheter lock solution and the other heparin 5000 iu/ml catheter lock solution.
Added 18/02/2010: trial was stopped because objectives were no longer viable.
Intervention type
Drug
Phase
Not Specified
Drug names
Taurolidine, citrate and heparin
Primary outcome measure
Rates of catheter-related bacteraemia
Secondary outcome measures
1. Rates of catheter occlusion
2. Mortality rate
3. Exit-site infection rates
4. Epoietin requirements
5. Hospitalisation
6. Haemodialysis adequacy
Overall trial start date
01/10/2006
Overall trial end date
01/10/2008
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Chronic renal failure requiring haemodialysis
2. Patients undergoing tunnelled haemodialysis catheter insertion
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
164
Participant exclusion criteria
1. Aged under 16 years
2. Known intolerance to heparin or taurolidine-citrate
3. Patients receiving antibiotic treatment
Recruitment start date
01/10/2006
Recruitment end date
01/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Renal Unit
Glasgow
G4 0SF
United Kingdom
Sponsor information
Funders
Funder type
Hospital/treatment centre
Funder name
Glasgow Royal Infirmary Renal Unit Research Fund (UK)
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
Basic results (scientific)
Publication list