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

Abstract

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

Locking solutions for prevention of central venous access device complications in the adult critical care population: A systematic review

“…Results of this original search also included one study protocol [ 32 ] which was excluded at that time as per exclusion criteria. Published results [ 33 ] were included in the final quality appraisal following their publication in 2022. Results of the search repeated on November 28 th , 2022 returned no further papers to include.…”

“…As shown in Table 1 , only the two studies [ 35 , 37 ] which investigated citrate at the higher 46.7% concentration show significant differences in median catheter lifespan, CVAD colonization, and occlusion. This is not including the study conducted by Pook et al [ 33 ] whose sample size was determined for feasibility and exploratory purposes only. Unfortunately, the more effective high concentration citrate formulations have been met with safety concerns which led to the FDA discouraging the use of the 46.7% concentration for catheter locking [ 42 ].…”

“…Out of the studies that included citrate as a comparator, the disparity in concentrations used (4% versus 46.7%) was considered to be too large to group all the papers in a single comparison condition. Although the standard of care condition in the study by Pook et al [ 33 ] also included both saline and citrate 4% use (depending on the type of CVAD), authors of the paper did not collect data related to outcomes in each of saline and citrate-locked CVADs separately. Although heparin and saline were used as a comparator for majority of the studies included in the review, only one paper [ 38 ] included their direct comparison.…”

Central line associated and primary bloodstream infections

“…A pilot randomized controlled trial assessed the feasibility and utility of chlorhexidine (di)gluconate lock solution placed in a central venous line within 72 h of admission to ICU [25]. This intervention resulted in a lower rate of central venous line colonization detected by surveillance blood cultures (18.7% vs. 29%, P = 0.009).…”

“…We identified seven recent studies that examined aspects of preventive efforts that have impact or relationship with primary BSIs relevant to critically ill patients [19 ▪▪ ,20–25]. Perhaps most notably is the Selective Decontamination of the Digestive Tract in the Intensive Care Unit (SuDDICU) trial aimed to assess whether gut decontamination would reduce in-hospital mortality in mechanically ventilated adults in the ICU [19 ▪▪ ].…”