Summary
Background The millions of peripheral intravenous catheters used each year are recommended for 72–96 h
replacement in adults. This routine replacement increases health-care costs and staff workload and requires patients
to undergo repeated invasive procedures. The eff ectiveness of the practice is not well established. Our hypothesis was
that clinically indicated catheter replacement is of equal benefi t to routine replacement.
Methods This multicentre, randomised, non-blinded equivalence trial recruited adults (≥18 years) with an intravenous
catheter of expected use longer than 4 days from three hospitals in Queensland, Australia, between May 20, 2008, and
Sept 9, 2009. Computer-generated random assignment (1:1 ratio, no blocking, stratifi ed by hospital, concealed before
allocation) was to clinically indicated replacement, or third daily routine replacement. Patients, clinical staff , and
research nurses could not be masked after treatment allocation because of the nature of the intervention. The primary
outcome was phlebitis during catheterisation or within 48 h after removal. The equivalence margin was set at 3%.
Primary analysis was by intention to treat. Secondary endpoints were catheter-related bloodstream and local infections,
all bloodstream infections, catheter tip colonisation, infusion failure, catheter numbers used, therapy duration,
mortality, and costs. This trial is registered with the Australian New Zealand Clinical Trials Registry, number
ACTRN12608000445370.
Findings All 3283 patients randomised (5907 catheters) were included in our analysis (1593 clinically indicated;
1690 routine replacement). Mean dwell time for catheters in situ on day 3 was 99 h (SD 54) when replaced as clinically
indicated and 70 h (13) when routinely replaced. Phlebitis occurred in 114 of 1593 (7%) patients in the clinically
indicated group and in 114 of 1690 (7%) patients in the routine replacement group, an absolute risk diff erence of
0·41% (95% CI –1·33 to 2·15%), which was within the prespecifi ed 3% equivalence margin. No serious adverse
events related to study interventions occurred.
Interpretation Peripheral intravenous catheters can be removed as clinically indicated; this policy will avoid millions
of catheter insertions, associated discomfort, and substantial costs in both equipment and staff workload. Ongoing
close monitoring should continue with timely treatment cessation and prompt removal for complications.