Routine Versus Clinically Indicated Replacement of Peripheral Intravenous Catheters in Adults: A Non-Inferiority Cluster-Randomised Crossover Trial

Background/Objectives: Routine replacement of peripheral intravenous catheters (PIVCs) every 72–96 h remains common practice despite growing guideline support for clinically indicated replacement. Evidence from Asian healthcare settings remains limited. Methods: A non-inferiority, cluster-randomised crossover trial was conducted from January to July 2021 across eight wards of a tertiary care hospital in South Korea. Adults requiring peripheral IV therapy for ≥96 h were allocated to routine 96-h replacement or clinically indicated replacement. The primary outcome was phlebitis incidence; a non-inferiority margin of 5% (absolute risk difference) was prespecified. Results: Among 1324 participants, phlebitis occurred in 12.6% (clinically indicated) vs. 11.7% (routine) (ARD 1.44 pp, 95% CI −1.47 to 4.35), meeting non-inferiority. No catheter-related bloodstream infections were observed in either group. The clinically indicated group required fewer catheter insertions (mean 1.77 vs. 2.16; p < 0.001) and had longer dwell times (mean 112.0 vs. 89.6 h; p < 0.001). Conclusions: Clinically indicated PIVC replacement was non-inferior to routine scheduled replacement for phlebitis and was associated with fewer insertions and longer dwell times, supporting its use in routine clinical practice.