氯己定或奥替尼啶抗菌沐浴对重症监护患者中心静脉相关血流感染的影响：一项集群随机对照试验。
Effect of antiseptic bathing with chlorhexidine or octenidine on central line-associated bloodstream infections in intensive care patients: a cluster-randomized controlled trial.
机构信息
Institute of Hygiene and Environmental Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany; National Reference Center for the Surveillance of Nosocomial Infections, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
Institute of Hygiene and Environmental Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany; National Reference Center for the Surveillance of Nosocomial Infections, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
出版信息
Clin Microbiol Infect. 2022 Jun;28(6):825-831. doi: 10.1016/j.cmi.2021.12.023. Epub 2022 Jan 11.
OBJECTIVES
Our study aimed to compare the effect of daily bathing with chlorhexidine, octenidine, or water and soap (routine care = control) on central line (CL)-associated bloodstream infection (CLABSI) rates in intensive care units (ICUs).
METHODS
A multicentre cluster-randomized controlled trial was done with a 12-month intervention period from February 1, 2017 to January 31, 2018 (octenidine and routine care group) or from June 1, 2017 to May 31, 2018 (chlorhexidine group). Wards were randomly assigned to one of two decolonization regimes or routine care (control). Intervention included daily bathing with 2% chlorhexidine-impregnated cloths or 0.08% octenidine wash mitts for 12 months, whereas the control group used water and soap (routine care). The primary outcome was incidence density of CLABSI per 1000 CL days. Poisson regression and generalized estimating equation models were applied.
RESULTS
A total of 72 ICUs with 76 815 patients (22 897 patients in the chlorhexidine group, 25 127 in the octenidine group, and 28 791 in the routine care group) were included. Incidence densities were 0.90 CLABSI per 1000 CL days (95% CI 0.67-1.19) in the chlorhexidine group, 1.47 (95% CI 1.17-1.81) in the octenidine group, and 1.17 (95% CI 0.93-1.45) in the routine care group. Adjusted incidence rate ratios of CLABSI were 0.69 (95% CI 0.37-1.22, p = 0.28) in the chlorhexidine group and 1.22 (95% CI 0.54-2.75, p = 0.65) in the octenidine group (compared with routine care).
DISCUSSION
Antiseptic bathing with 2% chlorhexidine-impregnated cloths and 0.08% octenidine wash mitts lacks a significant preventive effect on CLABSI rates in ICUs. However, our trial has a high likelihood of being underpowered because CLABSI rates in the routine care group were approximately 40% lower than initially assumed.
目的
本研究旨在比较氯己定、奥替尼啶和水及肥皂（常规护理=对照）每日沐浴对重症监护病房（ICU）中心静脉导管（CL）相关血流感染（CLABSI）发生率的影响。
方法
这是一项多中心集群随机对照试验，干预期为 2017 年 2 月 1 日至 2018 年 1 月 31 日（奥替尼啶和常规护理组）或 2017 年 6 月 1 日至 2018 年 5 月 31 日（氯己定组），共 12 个月。病房被随机分配到两种去定植方案或常规护理（对照）之一。干预措施包括用 2%氯己定浸渍布或 0.08%奥替尼啶洗涤手套每日沐浴 12 个月，而对照组使用水和肥皂（常规护理）。主要结局是每 1000 个 CL 天的 CLABSI 发生率密度。采用泊松回归和广义估计方程模型进行分析。
结果
共纳入 72 个 ICU 共 76815 例患者（氯己定组 22897 例，奥替尼啶组 25127 例，常规护理组 28791 例）。氯己定组的 CLABSI 发生率密度为 0.90/1000 CL 天（95%CI 0.67-1.19），奥替尼啶组为 1.47/1000 CL 天（95%CI 1.17-1.81），常规护理组为 1.17/1000 CL 天（95%CI 0.93-1.45）。CLABSI 的调整发病率比值分别为氯己定组 0.69（95%CI 0.37-1.22，p=0.28）和奥替尼啶组 1.22（95%CI 0.54-2.75，p=0.65）（与常规护理相比）。
讨论
用 2%氯己定浸渍布和 0.08%奥替尼啶洗涤手套进行抗菌沐浴对 ICU 中 CLABSI 发生率没有显著的预防作用。然而，我们的试验很可能没有足够的效力，因为常规护理组的 CLABSI 发生率比最初假设的低约 40%。
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