Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial

PURPOSE: Intensive care unit (ICU) patients are at risk for central line-associated bloodstream infection (CLABSI) with significant attributable mortality and increased hospital length of stay, readmissions, and costs. Chlorhexidine (di)gluconate (CHG) is used as a disinfectant for central line insertion; however, the feasibility and efficacy of using CHG as a locking solution is unknown. METHODS: Patients with a central venous access device (CVAD) in situ were randomized to standard care or a CHG lock solution (CHGLS) within 72 hours of ICU admission. The CHG solution was instilled in the lumen of venous catheters not actively infusing. CVAD blood cultures were taken at baseline and every 48 hours. The primary outcome was feasibility including recruitment rate, consent rate, protocol adherence, and staff uptake. Secondary outcomes included CVAD colonization, bacteraemia, and clinical endpoints. RESULTS: Of 3,848 patients screened, 122 were eligible for the study and consent was obtained from 82.0% of the patients or substitute decision makers approached. Fifty participants were allocated to each group. Tracking logs indicated that the CHGLS was used per protocol 408 times. Most nurses felt comfortable using the CHGLS. The proportion of central line colonization was significantly higher in the standard care group with 40 (29%) versus 26 (18.7%) in the CHGLS group (P=0.009). CONCLUSIONS: Using a device that delivers CHG into CVADs was feasible in the ICU. Findings from this trial will inform a full-scale randomized controlled trial and provide preliminary data on the effectiveness of CHGLS. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03309137, registered on October 13, 2017.