Department of Medicine, Vanderbilt University, Nashville, Tennessee.
Department of Biostatistics, Vanderbilt University, Nashville, Tennessee.
JAMA. 2015 Jan 27;313(4):369-78. doi: 10.1001/jama.2014.18400.
Daily bathing of critically ill patients with the broad-spectrum, topical antimicrobial agent chlorhexidine is widely performed and may reduce health care-associated infections.
To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of health care-associated infections.
DESIGN, SETTING, AND PARTICIPANTS: A pragmatic cluster randomized, crossover study of 9340 patients admitted to 5 adult intensive care units of a tertiary medical center in Nashville, Tennessee, from July 2012 through July 2013.
Units performed once-daily bathing of all patients with disposable cloths impregnated with 2% chlorhexidine or nonantimicrobial cloths as a control. Bathing treatments were performed for a 10-week period followed by a 2-week washout period during which patients were bathed with nonantimicrobial disposable cloths, before crossover to the alternate bathing treatment for 10 weeks. Each unit crossed over between bathing assignments 3 times during the study.
The primary prespecified outcome was a composite of central line-associated bloodstream infections (CLABSIs), catheter-associated urinary tract infections (CAUTIs), ventilator-associated pneumonia (VAP), and Clostridium difficile infections. Secondary outcomes included rates of clinical cultures that tested positive for multidrug-resistant organisms, blood culture contamination, health care-associated bloodstream infections, and rates of the primary outcome by ICU.
During the chlorhexidine bathing period, 55 infections occurred: 4 CLABSI, 21 CAUTI, 17 VAP, and 13 C difficile. During the control bathing period, 60 infections occurred: 4 CLABSI, 32 CAUTI, 8 VAP, and 16 C difficile. The primary outcome rate was 2.86 per 1000 patient-days during the chlorhexidine and 2.90 per 1000 patient-days during the control bathing periods (rate difference, -0.04; 95% CI, -1.10 to 1.01; P = .95). After adjusting for baseline variables, no difference between groups in the rate of the primary outcome was detected. Chlorhexidine bathing did not change rates of infection-related secondary outcomes including hospital-acquired bloodstream infections, blood culture contamination, or clinical cultures yielding multidrug-resistant organisms. In a prespecified subgroup analysis, no difference in the primary outcome was detected in any individual intensive care unit.
In this pragmatic trial, daily bathing with chlorhexidine did not reduce the incidence of health care-associated infections including CLABSIs, CAUTIs, VAP, or C difficile. These findings do not support daily bathing of critically ill patients with chlorhexidine.
clinicaltrials.gov Identifier: NCT02033187.
对重症患者进行每日全身沐浴并用广谱局部抗菌剂洗必泰,这一做法广泛应用于临床,可能有助于降低医疗保健相关感染的发生率。
确定每日对重症患者用洗必泰进行全身沐浴是否可以降低医疗保健相关感染的发生率。
设计、地点和参与者:这是一项在田纳西州纳什维尔的一家三级医疗中心的 5 个成人重症监护病房开展的实用群组随机交叉研究,共有 9340 名患者于 2012 年 7 月至 2013 年 7 月间入组。
各病房对所有患者实施一次全身沐浴,所用的浴布为浸有 2%洗必泰的一次性布或不含抗菌剂的布,前者作为干预组,后者作为对照组。患者先接受为期 10 周的沐浴治疗,然后进行为期 2 周的洗脱期,在此期间,患者使用不含抗菌剂的一次性布进行沐浴,随后再交叉到另一种沐浴治疗,持续 10 周。每个病房在研究期间交叉 3 次。
主要预设结局是中心静脉相关血流感染(CLABSI)、导管相关尿路感染(CAUTI)、呼吸机相关性肺炎(VAP)和艰难梭菌感染的复合结局。次要结局包括多重耐药菌阳性临床培养物的检出率、血培养污染、医疗保健相关血流感染的发生率,以及按 ICU 分层的主要结局发生率。
在洗必泰沐浴期,发生了 55 例感染:4 例 CLABSI、21 例 CAUTI、17 例 VAP 和 13 例艰难梭菌感染。在对照组的沐浴期,发生了 60 例感染:4 例 CLABSI、32 例 CAUTI、8 例 VAP 和 16 例艰难梭菌感染。洗必泰沐浴期的主要结局发生率为每 1000 个患者日 2.86 例,对照组为每 1000 个患者日 2.90 例(发生率差值,-0.04;95%CI,-1.10 至 1.01;P = .95)。调整基线变量后,两组间主要结局的发生率无差异。洗必泰沐浴并未改变感染相关的次要结局的发生率,包括医院获得性血流感染、血培养污染或检出多重耐药菌的临床培养物。在一个预先设定的亚组分析中,未在任何一个重症监护病房中发现主要结局的差异。
在这项实用试验中,每日用洗必泰对重症患者进行全身沐浴并未降低医疗保健相关感染的发生率,包括 CLABSI、CAUTI、VAP 或艰难梭菌感染。这些发现不支持对重症患者每日用洗必泰进行全身沐浴。
clinicaltrials.gov 标识符:NCT02033187。