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.
The joint commission CLABSI Toolkit notes that: Administration set (primary and secondary) replacement. The set is replaced no more frequently than every 96 hours, and at least every 7 days, after initiation of use unless contamination occurs. This replacement interval is safe and permits considerable cost savings to health care organizations,6,3,7 with the following exceptions: o Set is replaced immediately after administration of blood/blood products; o Set is replaced after 24 hours following administration of infusates that enhance microbial growth (for example, fat emulsions combined with aminoacids and glucose in three-in-one admixture or infused separately); and o Needleless components should be changed at least as often as the administration set and no more often than every 72 hours.
Rickard et al did a well-powered RCT to evaluate the difference of changing the practice of infusion line and infusate on the incidence of CRBSI where they found that compared to changing them on routine 4th day, a delayed change on 7th day does not cause more harm and is economical. Strengths: 1. Well-powered multicenter trial assessing many covariates and outcomes. 2. The outcome has real significance and impact on existing practice which was not evaluated ever scientifically. Weaknesses: 1. The protocol is very wide and used many mixed populations rather than concentrating mainly on central lines, which are the main source of CRBSI with grave clinical consequences. 2. Diverse types of lines, infusates possibly have diluted the primary outcome in the desired category. Impression: This is a timely required highly powered RCT to debunk the existing practice which is not evidence-based nor economical. However, the study should have concentrated only on CVCs.
This paper provides some much needed evidence about duration of replacing a central line. The outcome of this trial supports replacing these devices every 7 days rather than more frequently.