Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial
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.
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.
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).
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.
ClinicalTrials.gov Identifier NCT03309137, registered on October 13, 2017
Central venous access devices (CVADs) are essential for managing critically ill patients in the intensive care unit (ICU). Despite their utility and widespread use (Climo et al, 2003; Timsit et al, 2020), CVADs are associated with multiple complications, including central line-associated bloodstream infection (CLABSI) (Timsit et al, 2018; Xiong and Chen, 2018), with an incidence rate as high as 6.9 per 1,000 catheter days (Holton et al, 2006; Takashima et al, 2018; Wichmann et al, 2018). Central line-associated bloodstream infections have significant attributable mortality and increase in-hospital length of stay (LOS), readmissions, and costs (Haque et al, 2018). Recent literature found CLABSI to have an odds ratio up to 2.75 for in-hospital deaths (Ziegler et al, 2015; Huerta et al, 2018). In the United States, CLABSI has the second-highest attributable LOS of any hospital-acquired infection, at 15.7 days (Zimlichman et al, 2013). Furthermore, CLABSI patients are readmitted to the hospital at a higher rate than non-CLABSI patients (Khong et al, 2015) and increase healthcare costs by an average of US $45,814 per case (Khong et al, 2015; Stevens et al, 2014; Zimlichman et al, 2013).
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