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ISRCTN
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ISRCTN32633497
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ClinicalTrials.gov identifier
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Public title
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Role of antibiotic line locks in the prevention of tunnelled haemodialysis catheter infection: a double-blind, randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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08/05
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Haemodialysis catheter related sepsis
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Participants - inclusion criteria
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All patients requiring insertion of a tunnelled haemodialysis catheter (THDC) for haemodialysis.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2004
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Anticipated end date
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01/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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80
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Interventions
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Control group will receive usual heparin line locks between dialysis sessions.
Intervention group will receive a line lock containing heparin, vancomycin and gentamicin.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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Funded within our department
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Trial website
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Publications
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Contact name
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Dr
Peter
McClelland
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Address
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Arrowe Park Hospital
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City/town
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Liverpool
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Zip/Postcode
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CH49 5PE
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Country
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United Kingdom
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Sponsor
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Wirral Hospitals NHS Trust (UK)
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Address
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Arrowe Park Hospital
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City/town
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Liverpool
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Zip/Postcode
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CH49 5PE
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Country
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United Kingdom
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Date applied
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07/06/2004
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Last edited
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14/10/2009
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Date ISRCTN assigned
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26/09/2005
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