Background Critically 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. Methods The 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. Discussion This 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 registration ClinicalTrials.gov, NCT03309137, registered on October 13, 2017.

中文翻译：

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用于 ICU 患者中线感染预防的氯己定锁定装置：开放标签试点和可行性随机对照试验方案。

背景重症监护病房 (ICU) 中的重症患者存在中心导管相关血流感染 (CLABSI) 的风险，其发病率高达每 1000 导管日 6.9 例。CLABSI 具有显着的归因死亡率，并增加了住院时间、再入院时间和成本。葡萄糖酸氯己定 (CHG) 是一种广谱杀菌剂，已被证明可有效减少包括 CLABSI 在内的感染；然而，很少有试验使用 CHG 来预防中心线感染。我们的临床前工作已经证明了一种装置，可以将 CHG 扩散到中心静脉导管的静脉闭锁溶液中，并减少导管管腔上的细菌生长。我们设计了一项临床试验来测试在 ICU 患者群体中使用 CHG 设备的可行性。方法 拟议的试点试验将是一个单一的中心，开放标签、双臂、平行组可行性随机对照试验（RCT）。参与者将在原位有一条中心线，并将在进入单一学术医院的 3 个 ICU 后的 72 小时内登记。排除标准将包括疑似感染、长期留置导管和 CHG 过敏。在随机化之前，将获得符合条件的参与者或其替代决策者的知情同意。参与者将随机接受常规护理或 CHG 锁定装置。每 48 小时从所有参与者中抽取血培养。本研究的主要目的是确定使用该方案进行更大规模试验的可行性。可行性将通过以下结果进行评估：（1）同意率，（2）招募率，（3）协议依从性，(4) 设备的舒适度。本研究的次要目标是确定该装置的初步功效。讨论 这项研究将是第一个研究用于预防中心线感染的 CHG 锁定装置的人类 RCT。该试验的结果将告知进行大型 RCT 的可行性，并提供有关 CHG 锁定装置功效的初步数据。试验注册 ClinicalTrials.gov，NCT03309137，注册于 2017 年 10 月 13 日。该试验的结果将告知进行大型 RCT 的可行性，并提供有关 CHG 锁定装置功效的初步数据。试验注册 ClinicalTrials.gov，NCT03309137，注册于 2017 年 10 月 13 日。该试验的结果将告知进行大型 RCT 的可行性，并提供有关 CHG 锁定装置功效的初步数据。试验注册 ClinicalTrials.gov，NCT03309137，注册于 2017 年 10 月 13 日。