Role of antibiotic line locks in the prevention of tunnelled haemodialysis catheter infection: a double blind randomised controlled trial

ISRCTN	ISRCTN93619348
DOI	https://doi.org/10.1186/ISRCTN93619348
Secondary identifying numbers	N0280178863

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Peter McClelland
Scientific

Arrowe Park Hospital
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Phone	+44 0151 678 5111
Email	jonathon.davies@whnt.nhs.uk

Study design	Single centre double blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Will locking dialysis catheters with antibiotics immediately after placement into the patient reduce infection rate and prolong their life-span?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Injury, Occupational Diseases, Poisoning: Haemodialysis catheter infection
Intervention	1G of vancomycin intraveously before catheter insertion. The catheter site will be inspected at each dialysis and cleaned with 10% aqueous povidone-iodine solution after each dialysis and each time the patient bathes.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Antibiotics
Primary outcome measure	Time in days to catheter-related infections.
Secondary outcome measures	1. Haemoglobin concentration 2. Erythropoetin dose 3. Serum albumin concentration 4. Hospital admission rate 5. Mean length of hospital stay
Overall study start date	01/06/2006
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	80
Key inclusion criteria	Patients aged 18 and above, stratified according to their diabetic status, requiring the insertion of a new tunnelled haemodyalisis catheter.
Key exclusion criteria	1. Antibiotics for longer than 2 weeks 2. Pregnancy or planned pregnancy 3. Pregnancy 4. Allergy to vancomycin or gemtamicin 5. History of heparin induced thrombocytopaenia
Date of first enrolment	01/06/2006
Date of final enrolment	30/06/2008

Arrowe Park Hospital

Wirral
CH49 5PE
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Wirral Hospitals NHS Trust

No information available

NHS R&D Support Funding

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2008		Yes	No