A randomised controlled trial comparing taurolidine-citrate with heparin for locking tunnelled haemodialysis catheters

ISRCTN	ISRCTN13630682
DOI	https://doi.org/10.1186/ISRCTN13630682
Protocol serial number	N/A
Sponsor	North Glasgow University NHS Division (UK)
Funder	Glasgow Royal Infirmary Renal Unit Research Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Scott Morris
Scientific

Renal Unit
3rd Floor Walton Building
Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Primary study design	Interventional
Study design	Interventional randomised double-blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Medical Research Ethics Committee for Scotland A (reference: 06/MRE00/43), approval received 13/06/2006.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Taurolidine, citrate and heparin
Primary outcome measure(s)	Rates of catheter-related bacteraemia
Key secondary outcome measure(s)	1. Rates of catheter occlusion 2. Mortality rate 3. Exit-site infection rates 4. Epoietin requirements 5. Hospitalisation 6. Haemodialysis adequacy
Completion date	01/10/2008
Reason abandoned (if study stopped)	Objectives no longer viable

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	164
Key inclusion criteria	1. Chronic renal failure requiring haemodialysis 2. Patients undergoing tunnelled haemodialysis catheter insertion
Key exclusion criteria	1. Aged under 16 years 2. Known intolerance to heparin or taurolidine-citrate 3. Patients receiving antibiotic treatment
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2008

Renal Unit

Glasgow
G4 0SF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan