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

ISRCTN	ISRCTN32633497
DOI	https://doi.org/10.1186/ISRCTN32633497
Protocol serial number	08/05
Sponsor	Wirral Hospitals NHS Trust (UK)
Funder	Funded within our department

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 Peter McClelland
Scientific

Arrowe Park Hospital
Liverpool
CH49 5PE
United Kingdom

Primary study design	Interventional
Study design	Randomised double blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The null hypothesis to be tested is that antibiotic line locks will not reduce the incidence of catheter related blood stream infection compared with the standard practice of catheter filling with heparin alone.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Haemodialysis catheter related sepsis
Intervention	Control group will receive usual heparin line locks between dialysis sessions. Intervention group will receive a line lock containing heparin, vancomycin and gentamicin.
Intervention type	Other
Primary outcome measure(s)	The time in days from insertion of tunnelled haemodialysis catheter (THDC) to first catheter related infection (CRI). CRI will be diagnosed by a combination of clinical suspicion, raised temperature, blood tests (white cell count and inflammatory markers) and the results of blood cultures from the tunnelled haemodialysis catheter (THDC) and from a peripheral vein.
Key secondary outcome measure(s)	1. Mean haemoglobin concentration 2. Mean erythropoietin dose adjusted for body mass 3. Mean serum albumin concentration 4. Mean number of days in hospital per annum 5. Mean number of hospital admissions per annum
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key inclusion criteria	All patients requiring insertion of a tunnelled haemodialysis catheter (THDC) for haemodialysis.
Key exclusion criteria	1. Patients on prolonged courses of antibiotics (oral or parenteral) i.e. for greater than 2 weeks. (This may reduce the incidence of CRI and therefore confound the results). 2. Patients with a known allergy to vancomycin or gentamicin 3. Patients known to suffer from heparin induced thrombocytopenia 4. Patients who are pregnant or plan to become pregnant. (Vancomycin and gentamicin are potentially toxic to the fetus). 5. An inability to provide informed consent to participation in the study
Date of first enrolment	01/08/2004
Date of final enrolment	01/08/2006

Arrowe Park Hospital

Liverpool
CH49 5PE
United Kingdom

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