Abstract
BackgroundCritically ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days. CLABSI has a significant attributable mortality and increases in-hospital length of stay, readmissions, and costs. Chlorhexidine gluconate (CHG), a broad-spectrum biocide, has been shown to effectively reduce infections including CLABSI; however, few trials have utilized CHG for prevention of central line infections. Our preclinical work has demonstrated a device that diffuses CHG into the intravenous lock solution of central venous catheters and decreases bacterial growth on the catheter lumen. We designed a clinical trial to test the feasibility of using a CHG device in an ICU patient population.MethodsThe proposed pilot trial will be a single centre, open-label, two-arm, parallel group feasibility randomized controlled trial (RCT). Participants will have a central line in situ and will be enrolled within 72 h of admittance to 3 ICUs at a single academic hospital. Exclusion criteria will include suspected infection, chronic indwelling catheters, and CHG allergy. Informed consent will be obtained from eligible participants or their substitute decision maker prior to randomization. Participants will be randomized to receive either usual care or the CHG locking device. Blood cultures will be drawn from all participants every 48 h. The primary objective of this study will be to determine the feasibility of using this protocol to conduct a larger trial. Feasibility will be assessed through the following outcomes: (1) consent rate, (2) recruitment rate, (3) protocol adherence, and (4) comfort level with the device. The secondary objective of this study will be to establish the preliminary efficacy of the device.DiscussionThis study will be the first human RCT to investigate a CHG locking device for the prevention of central line infections. Findings from this trial will inform the feasibility of conducting a large RCT and provide preliminary data on the efficacy of a CHG locking device.Trial registrationClinicalTrials.gov, NCT03309137, registered on October 13, 2017.
Highlights
Ill patients in the intensive care unit (ICU) are at risk for central line-associated bloodstream infection (CLABSI) with an incidence up to 6.9 per 1000 catheter days
A retrospective case-controlled cohort study of 11,802 hospitalizations in the USA reported that 10.4% more CLABSI patients were readmitted to a hospital within 30 days of discharge compared to non-CLABSI patients [15]
In patients admitted to the ICU with a Central venous catheter (CVC) in situ, does Chlorhexidine gluconate (CHG) locking solution administered by the ChloraLockTM device reduce risk of intravenous line colonization and improve patient and hospital outcomes by preventing cases of CLABSI?
Summary
Study design The ChloraLockTM pilot trial is a single centre, open-label, two-arm, parallel-group feasibility RCT. A ‘flushing and locking log’ will be kept at the bedside of all study participants and will require nurses to document each time they access a venous catheter to perform flushing or locking procedures. We will document and report protocol deviations including failure to use ChloraLockTM to administer CHG locking solution, aspirate CHG from a venous catheter upon re-accessing the line, and draw a blood culture from the CVC of a patient every 48 h. Survey development To determine the comfort level of ICU nurses with the ChloraLockTM device and trial protocol, we will administer a paper-based survey to nurses who treat a study participant (see Additional file 5). Once written informed consent has been obtained, the research team will unseal an opaque envelope in sequence to randomize patients to receive usual care or CHG locking device.
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