CHG-Lock Device for Prevention of Central line Infections in the ICU - an Open Label Randomized Pilot Study: Protocol
CCCF ePoster library. Zamir N. Nov 8, 2018; 233357; 80 Disclosure(s): ICU Medical is the financial sponsor of the study. ATTWILL Medical Solutions is the inventor of the CHGLock(TM) device.
Dr. Nasim Zamir
Dr. Nasim Zamir
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Background: In North America, 87% of nosocomial primary bloodstream infections are attributed to central venous catheters (CVCs).1 Chlorhexidine Gluconate (CHG) is a broad-spectrum biocide2 and trials suggest its topical application may decrease infection, specifically central line associated bloodstream infections (CLABSI)3,4,5. However, few trials have utilized CHG with intravenous (IV) lines. The CHG-LockTM device, is a sterile attachment loaded with freeze-dried CHG that luer-locks onto a prefilled syringe, sterilizing the solution and line when passed through.

Objective: The aim of the CHG-LockTM pilot trial (NCT03309137) is to determine the feasibility of conducting a larger trial of CHG-LockTM devices to reduce CLABSI in the intensive care unit (ICU). Secondary objectives are the number of CLABSI infections and staff comfort with device use.

Methods: Adults admitted to the ICU expected to remain in ICU for ≥72 hours with a central line in-situ will be randomized to the CHG-LockTM device or standard of care. We will exclude patients with a chronic indwelling catheter, suspected infection, or CHG allergy. Randomization will be in variable block sizes at a fixed 1:1 ratio. To ensure allocation concealment, a third party will prepare sequentially numbered, opaque, sealed envelopes.6 Patients randomized to the CHG-LockTM arm will have all central and peripheral IV lines locked with the device and unused ports relocked every 24 hours or after use.  Blood cultures will be collected from all patients with a central line every 48 hours until the central line removal or ICU transfer.

Results: Feasibility will be determined by: 1) ≥80% consent; 2) Recruitment of 100 patients over 1 year; and 3) Protocol adherence; assessed by ICU nurse surveys. The clinical outcomes to be measured include:  CVC colonization, bacteremia, sepsis, mortality, and length of stay. Protocol adherence and staff comfort with device use will be presented with run charts that indicate team initiated adherence improvement efforts. Continuous variables will be compared with t-test and Mann-Whitney U-tests for parametric and non-parametric data sets respectively. Odds Ratios will be calculated through Fisher’s exact test for dichotomous variables. Descriptive statistics will be reported with appropriate central tendencies and spread. Intention to treat analyses using Kaplan-Meier time to event curves for CLASBI, bacteremia, sepsis and mortality will be performed for both arms. The results will also inform the sample size calculations of subsequent trials.

Discussion: Touch contamination of central lines and hematogenous spread secondary to enteric bacterial translocation are the most common causes of CLABSI in the critically ill. Central lines then become a nidus for bacterial growth. While experience with central line insertion and handling can reduce infection, additional strategies such as use of indwelling bacteriocidal agents may provide further benefit. We present our protocol to encourage investigators to consider that device trials, like drug trials, require rigorous assessment.  


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