• Claire M Rickard, Nicole M Marsh, Joan Webster, Nicole C Gavin, Matthew R McGrail, Emily Larsen, Amanda Corley, Debbie Long, John R Gowardman, Marghie Murgo, John F Fraser, Raymond J Chan, Marianne C Wallis, Jeanine Young, David McMillan, Li Zhang, Md Abu Choudhury, Nicholas Graves, and E Geoffrey Playford.
• NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Royal Brisbane and Women's Hospital, Brisbane, Australia Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Australia.
• BMJ Open. 2015 Feb 3; 5 (2): e007257.

IntroductionVascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3-4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload.Methods And AnalysisThis is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.Ethics And DisseminationRelevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care.Trial Registration NumberAustralian New Zealand Clinical Trial Registry (ACTRN 12610000505000).Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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