Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial

doi:10.1016/S0140-6736(21)00351-2

Randomized Controlled Trial

. 2021 Apr 17;397(10283):1447-1458.

doi: 10.1016/S0140-6736(21)00351-2.

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial

Claire M Rickard¹, Nicole M Marsh², Emily N Larsen³, Matthew R McGrail⁴, Nicholas Graves⁵, Naomi Runnegar⁶, Joan Webster³, Amanda Corley⁷, David McMillan⁸, John R Gowardman⁹, Debbie A Long¹⁰, John F Fraser¹¹, Fenella J Gill¹², Jeanine Young⁸, Marghie Murgo¹³, Evan Alexandrou¹⁴, Md Abu Choudhury¹⁵, Raymond J Chan¹⁶, Nicole C Gavin¹⁷, Azlina Daud¹⁸, Annamaria Palermo¹⁹, Adrian Regli²⁰, E Geoffrey Playford⁶

Affiliations

¹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia. Electronic address: c.rickard@uq.edu.au.
² School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
³ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
⁴ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia.
⁵ Health Services and Systems Research, Duke-National University of Singapore, Medical School, Singapore.
⁶ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.
⁷ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia.
⁸ School of Health and Sports Sciences, School of Nursing, Midwifery and Paramedicine, and INFLAME Biomedical Research Cluster, The University of the Sunshine Coast, Sippy Downs, QLD, Australia.
⁹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
¹⁰ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia; Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.
¹¹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia.
¹² School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing, Midwifery and Paramedicine, Curtin University, Kent Street, Bentley, WA, Australia; Perth Children's Hospital, Child and Adolescent Health Service, Nedlands, WA, Australia.
¹³ Partnering with Consumers, Australian Commission on Safety and Quality in Healthcare, Sydney, NSW, Australia.
¹⁴ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing and Midwifery, Western Sydney University, Penrith, NSW, Australia; Centre for Applied Nursing Research and Ingham Institute for Applied Medical Research, South Western Sydney LHD, Liverpool, NSW, Australia; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia.
¹⁵ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.
¹⁶ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia.
¹⁷ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia.
¹⁸ Faculty of Nursing, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Kuantan Campus, Kuantan, Pahang, Malaysia.
¹⁹ Intensive Care Unit, St John of God Murdoch Hospital, Murdoch, WA, Australia.
²⁰ Intensive Care Unit, St John of God Murdoch Hospital, Murdoch, WA, Australia; Medical School, The University of Western Australia, Sterling Highway, Crawley, WA, Australia; Medical School, The Notre Dame University, Henry Road, Fremantle, WA, Australia.

PMID: 33865494
DOI: 10.1016/S0140-6736(21)00351-2

Randomized Controlled Trial

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial

Claire M Rickard et al. Lancet. 2021.

. 2021 Apr 17;397(10283):1447-1458.

doi: 10.1016/S0140-6736(21)00351-2.

Authors

Affiliations

¹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia. Electronic address: c.rickard@uq.edu.au.
² School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
³ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
⁴ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia.
⁵ Health Services and Systems Research, Duke-National University of Singapore, Medical School, Singapore.
⁶ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.
⁷ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia.
⁸ School of Health and Sports Sciences, School of Nursing, Midwifery and Paramedicine, and INFLAME Biomedical Research Cluster, The University of the Sunshine Coast, Sippy Downs, QLD, Australia.
⁹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
¹⁰ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia; Paediatric Intensive Care Unit, Queensland Children's Hospital, South Brisbane, QLD, Australia.
¹¹ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia.
¹² School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing, Midwifery and Paramedicine, Curtin University, Kent Street, Bentley, WA, Australia; Perth Children's Hospital, Child and Adolescent Health Service, Nedlands, WA, Australia.
¹³ Partnering with Consumers, Australian Commission on Safety and Quality in Healthcare, Sydney, NSW, Australia.
¹⁴ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; School of Nursing and Midwifery, Western Sydney University, Penrith, NSW, Australia; Centre for Applied Nursing Research and Ingham Institute for Applied Medical Research, South Western Sydney LHD, Liverpool, NSW, Australia; Department of Intensive Care, Liverpool Hospital, Liverpool, NSW, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, NSW, Australia.
¹⁵ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia.
¹⁶ School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia.
¹⁷ School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; School of Nursing, and Cancer and Palliative Care Outcomes Centre, Queensland University of Technology, Kelvin Grove, QLD, Australia.
¹⁸ Faculty of Nursing, International Islamic University Malaysia, Jalan Sultan Ahmad Shah, Kuantan Campus, Kuantan, Pahang, Malaysia.
¹⁹ Intensive Care Unit, St John of God Murdoch Hospital, Murdoch, WA, Australia.
²⁰ Intensive Care Unit, St John of God Murdoch Hospital, Murdoch, WA, Australia; Medical School, The University of Western Australia, Sterling Highway, Crawley, WA, Australia; Medical School, The Notre Dame University, Henry Road, Fremantle, WA, Australia.

PMID: 33865494
DOI: 10.1016/S0140-6736(21)00351-2

Abstract

Background: The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters.

Methods: We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device-peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete.

Findings: Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI -0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, -0·27% to 0·83%). There were no treatment-related adverse events.

Interpretation: Infusion set use can be safely extended to 7 days with resultant cost and workload reductions.

Funding: Australian National Health and Medical Research Council.

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Conflict of interest statement

Declaration of interests CMR's employer has received on her behalf from manufacturers of vascular access products: investigator-initiated research grants and unrestricted educational grants from BD-Bard and Cardinal Health; and consultancy payments for educational lectures and expert advice from 3M, and BD-Bard. NMM's employer has received on her behalf from manufacturers of vascular access products investigator-initiated research grants and unrestricted educational grants from BD-Bard and Cardinal Health; and consultancy payments for educational lectures from 3M. ENL's employer has received on her behalf from manufacturers of vascular access products an investigator-initiated research grant from Cardinal Health; and a conference scholarship from Angiodynamics. AC's employer has received on her behalf from manufacturers of vascular access products investigator-initiated research grants from Cardinal Health. EA's employer has received on his behalf from manufacturers of vascular access products: investigator-initiated research grants from BD-Bard. All other authors declare no competing interests.

Comment in

Extending infusion set replacement intervals to preserve resources and reduce waste.
Soop M. Soop M. Lancet. 2021 Apr 17;397(10283):1420-1421. doi: 10.1016/S0140-6736(21)00791-1. Lancet. 2021. PMID: 33865481 No abstract available.

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Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial

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Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial

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