TY - JOUR
T1 - Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP)
T2 - a randomised, controlled, equivalence (central venous access device)–non-inferiority (peripheral arterial catheter) trial
AU - Rickard, Claire M.
AU - Marsh, Nicole M.
AU - Larsen, Emily N.
AU - McGrail, Matthew R.
AU - Graves, Nicholas
AU - Runnegar, Naomi
AU - Webster, Joan
AU - Corley, Amanda
AU - McMillan, David
AU - Gowardman, John R.
AU - Long, Debbie A.
AU - Fraser, John F.
AU - Gill, Fenella J.
AU - Young, Jeanine
AU - Murgo, Marghie
AU - Alexandrou, Evan
AU - Choudhury, Md Abu
AU - Chan, Raymond J.
AU - Gavin, Nicole C.
AU - Daud, Azlina
AU - Palermo, Annamaria
AU - Regli, Adrian
AU - Playford, E. Geoffrey
N1 - Funding Information:
We thank our patients and their families for participation. We acknowledge major trial funding from the Australian National Health and Medical Research Council (APP1008428), the Australian Government Research Training Scheme (Nicole Gavin), and seed funds from the Australian College of Critical Care Nurses, and Cancer Nursing Society Australia. We thank the staff at each hospital: Julie Flynn, Elise Button, and Melissa Lassig-Smith (Royal Brisbane and Women's Hospital); Melissa Arneil, Reto Fedori, Fiona Fullerton, Chelsea Davis, Sarah Lepelaar, Krista Wetzig, Leanne Aitken, and Marion Mitchell (Princess Alexandra Hospital); Kirsten Franzen, Tara Williams, and Robin Hardy (Royal Children's Hospital–Queensland Children's Hospital); Brigit Roberts and Stuart Baker (Sir Charles Gairdner Hospital); Sharon Micallef, Nicholas Mifflin, and Kerry Bradshaw (Liverpool Hospital); Samantha Barba, Samantha Barr, Martina Barnwell, and Sara Shea (Princess Margaret Hospital); Melannie Edwards, India Lye, Amy Spooner, and Rebecca Taylor (The Prince Charles Hospital); Jennifer Coakley and Megan Stavropoulos (Royal Prince Alfred Hospital); and staff of St John of God Murdoch. We thank the DSMC members (Vineet Chopra, Suhail Doi, Craig McBride, Kersi Tarapowella, Lukman Thalib, and Andre Van Zundert). We acknowledge Nick Rossow for eResearch support, and Michelle Bauer and Malin Olsson for their microbiological work. CMR and JW acknowledge support through the Australian National Health and Medical Research Council Centre of Research Excellence scheme. We acknowledge Michael Whitby, Marianne Wallis, and Li Zhang for assistance with the funding application. JFF acknowledges support through a Health Research Fellowship from the Office of Health and Medical Research, Queensland Health.
Funding Information:
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.
Funding Information:
We thank our patients and their families for participation. We acknowledge major trial funding from the Australian National Health and Medical Research Council (APP1008428), the Australian Government Research Training Scheme (Nicole Gavin), and seed funds from the Australian College of Critical Care Nurses, and Cancer Nursing Society Australia. We thank the staff at each hospital: Julie Flynn, Elise Button, and Melissa Lassig-Smith (Royal Brisbane and Women's Hospital); Melissa Arneil, Reto Fedori, Fiona Fullerton, Chelsea Davis, Sarah Lepelaar, Krista Wetzig, Leanne Aitken, and Marion Mitchell (Princess Alexandra Hospital); Kirsten Franzen, Tara Williams, and Robin Hardy (Royal Children's Hospital?Queensland Children's Hospital); Brigit Roberts and Stuart Baker (Sir Charles Gairdner Hospital); Sharon Micallef, Nicholas Mifflin, and Kerry Bradshaw (Liverpool Hospital); Samantha Barba, Samantha Barr, Martina Barnwell, and Sara Shea (Princess Margaret Hospital); Melannie Edwards, India Lye, Amy Spooner, and Rebecca Taylor (The Prince Charles Hospital); Jennifer Coakley and Megan Stavropoulos (Royal Prince Alfred Hospital); and staff of St John of God Murdoch. We thank the DSMC members (Vineet Chopra, Suhail Doi, Craig McBride, Kersi Tarapowella, Lukman Thalib, and Andre Van Zundert). We acknowledge Nick Rossow for eResearch support, and Michelle Bauer and Malin Olsson for their microbiological work. CMR and JW acknowledge support through the Australian National Health and Medical Research Council Centre of Research Excellence scheme. We acknowledge Michael Whitby, Marianne Wallis, and Li Zhang for assistance with the funding application. JFF acknowledges support through a Health Research Fellowship from the Office of Health and Medical Research, Queensland Health.
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/4/17
Y1 - 2021/4/17
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85104090922&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(21)00351-2
DO - 10.1016/S0140-6736(21)00351-2
M3 - Article
C2 - 33865494
AN - SCOPUS:85104090922
SN - 0140-6736
VL - 397
SP - 1447
EP - 1458
JO - The Lancet
JF - The Lancet
IS - 10283
ER -
