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

Introduction: 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 and Analysis: 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.; Ethics and Dissemination: 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.; Trial Registration Number: Australian 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.)Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S12-21. (PMID: 18840084); MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29. (PMID: 12233868); J Intraven Nurs. 1996 Jan-Feb;19(1):5-14. (PMID: 8708844); Oncol Nurs Forum. 1998 Jun;25(5):907-13. (PMID: 9644707); Crit Care Med. 1994 Sep;22(9):1424-30. (PMID: 8062565); Am J Infect Control. 2008 Feb;36(1):48-53. (PMID: 18241736); Infect Control Hosp Epidemiol. 2001 Mar;22(3):136-9. (PMID: 11310690); Mayo Clin Proc. 2006 Sep;81(9):1159-71. (PMID: 16970212); Infect Control Hosp Epidemiol. 1999 Jul;20(7):487-93. (PMID: 10432161); J Hosp Infect. 1986 Nov;8(3):217-23. (PMID: 2878025); J Adv Nurs. 2002 Feb;37(4):330-7. (PMID: 11872102); Clin Infect Dis. 2009 Jul 1;49(1):1-45. (PMID: 19489710); Crit Care Med. 1988 Mar;16(3):272-6. (PMID: 3277784); Am J Med. 1976 Apr;60(4):471-85. (PMID: 1274981); N Engl J Med. 1977 Jun 9;296(23):1305-9. (PMID: 323710); Eur J Clin Microbiol Infect Dis. 2000 Jan;19(1):1-8. (PMID: 10706172); J Clin Nurs. 2009 Nov;18(21):3022-8. (PMID: 19821874); Cochrane Database Syst Rev. 2013;(9):CD003588. (PMID: 24037784); Infect Control Hosp Epidemiol. 2004 Aug;25(8):650-5. (PMID: 15357156); Clin Infect Dis. 2011 May;52(9):e162-93. (PMID: 21460264); Infection. 2006 Oct;34(5):258-63. (PMID: 17033749); Infect Control. 1985 Sep;6(9):367-70. (PMID: 3932250); Infect Control Hosp Epidemiol. 2002 May;23(5):249-53. (PMID: 12026149); Arch Intern Med. 1990 Jul;150(7):1417-20. (PMID: 2196026); Ann Intern Med. 1979 Aug;91(2):173-8. (PMID: 111593); Am J Epidemiol. 1983 Dec;118(6):839-51. (PMID: 6650485); BMJ. 2008;337:a339. (PMID: 18614482); Ann Clin Microbiol Antimicrob. 2003 Feb 27;2:3. (PMID: 12643811); Can J Gastroenterol. 1999 Mar;13(2):147-51. (PMID: 10203434); Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S22-30. (PMID: 18840085); JAMA. 1986 Feb 21;255(7):916-20. (PMID: 3944997). Linking ISSN: 20446055. Subset: MEDLINE; Date of Electronic Publication: 2015 Feb 03. ; Original Imprints: Publication: [London] : BMJ Publishing Group Ltd, 2011- <br />