title: Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients-a study protocol for a randomised controlled trial (The RSVP Trial).
abstract: BACKGROUND
  Vascular 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
  This 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.
  
  
  BACKGROUND
  Relevant 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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).
authors: 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.
authors: Claire M
authors: CM
authors: Rickard
authors: 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.
authors: Nicole M
authors: NM
authors: Marsh
authors: 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.
authors: Joan
authors: J
authors: Webster
authors: 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.
authors: Nicole C
authors: NC
authors: Gavin
authors: School of Rural Health, Monash University, Churchill, Australia.
authors: Matthew R
authors: MR
authors: McGrail
authors: 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.
authors: Emily
authors: E
authors: Larsen
authors: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Australia.
authors: Amanda
authors: A
authors: Corley
authors: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Lady Cilento Children's Hospital, Brisbane, Australia.
authors: Debbie
authors: D
authors: Long
authors: 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.
authors: John R
authors: JR
authors: Gowardman
authors: Clinical Excellence Commission, Sydney, Australia Royal Prince Alfred Hospital, Sydney, Australia.
authors: Marghie
authors: M
authors: Murgo
authors: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Australia.
authors: John F
authors: JF
authors: Fraser
authors: 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 Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
authors: Raymond J
authors: RJ
authors: Chan
authors: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia School of Nursing and Midwifery, University of the Sunshine Coast, Maroochydore, Australia.
authors: Marianne C
authors: MC
authors: Wallis
authors: Lady Cilento Children's Hospital, Brisbane, Australia School of Nursing and Midwifery, University of the Sunshine Coast, Maroochydore, Australia.
authors: Jeanine
authors: J
authors: Young
authors: Inflammation and Healing Research Cluster, School of Health and Sport Sciences, University of the Sunshine Coast, Maroochydore, Australia.
authors: David
authors: D
authors: McMillan
authors: Inflammation and Healing Research Cluster, School of Health and Sport Sciences, University of the Sunshine Coast, Maroochydore, Australia.
authors: Li
authors: L
authors: Zhang
authors: 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.
authors: Md Abu
authors: MA
authors: Choudhury
authors: Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
authors: Nicholas
authors: N
authors: Graves
authors: NHMRC Centre of Research Excellence in Nursing (NCREN), Centre for Health Practice Innovation-Griffith Health Institute, Griffith University, Brisbane, Australia Infection Management Services, Princess Alexandra Hospital, Brisbane, Australia.
authors: E Geoffrey
authors: EG
authors: Playford
mesh_terms: D055499:Catheter-Related Infections / Q000517:prevention & control*; D002406:Catheterization, Peripheral / Q000009:adverse effects; D002408:Catheters, Indwelling / Q000009:adverse effects; D062905:Central Venous Catheters / Q000009:adverse effects; D002985:Clinical Protocols; D020878:Device Removal / Q000592:standards*; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D010689:Phlebitis / Q000209:etiology*; D012107:Research Design; D062666:Vascular Access Devices / Q000009:adverse effects
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