Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: a multicenter randomized controlled study.
Comparison of the efficacy of three topical antiseptic solutions for the prevention of catheter colonization: a multicenter randomized controlled study.
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DOI：
10.1186/s13054-017-1890-z
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发表时间：
2017-12-21
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影响因子：
--
通讯作者：
for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
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文献类型：
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作者：
Yasuda H;Sanui M;Abe T;Shime N;Komuro T;Hatakeyama J;Matsukubo S;Kawano S;Yamamoto H;Andoh K;Seo R;Inoue K;Noda E;Saito N;Nogami S;Okamoto K;Fuke R;Gushima Y;Kobayashi A;Takebayashi T;Lefor AK;for Japanese Society of Education for Physicians and Trainees in Intensive Care (JSEPTIC) Clinical Trial Group
为了比较三种消毒液[0.5%、1.0%酒精/葡萄糖酸洗必泰(CHG)和10%聚维酮碘(PVI)]预防血管内导管定植的效果，我们在日本16个重症监护病房的患者中进行了一项随机对照试验。接受中心静脉或动脉导管插入的成年患者被随机分配到三种消毒液中的一种，在导管插入和换药期间应用。主要终点是导管定植率，次要终点是导管相关性血流感染(CRBSI)。在随机抽取的1132个导尿管中，796个(70%)纳入了完整的分析集合。0.5%CHG组、1%CHG组和PVI组的导管尖端定植发生率分别为每千根导管日3.7、3.9和10.5次事件(p = 0.03)。两组导管定植比较显示，PVI组导管定植风险显著高于PVI组(0.5%CHG与PVI：危险比，HR 0.33[95%可信区间，CI 0.12-0.95]，p = 0.04；1.0%CHG与PVI：HR 0.35[95%CI 0.13-0.93]，p = 0.04)。包括所有患者在内的敏感性分析显示出一致的定量结论(0.5%CHG与PVI：HR 0.34，p = 0.03；1.0%CHG与PVI：HR 0.35，p = 0.04)。两组间CRBSI发生率差异无统计学意义。在预防血管内导管定植方面，0.5%和1.0%乙醇CHG均优于10%PVI。日本初级登记处网络；编号：UMIN0000087252012年9月1日登记。本文的在线版本(DOI：10.1186/s130541890-z)载有补充材料，授权用户可查阅。
To compare the efficacy of three antiseptic solutions [0.5%, and 1.0% alcohol/chlorhexidine gluconate (CHG), and 10% aqueous povidone-iodine (PVI)] for the prevention of intravascular catheter colonization, we conducted a randomized controlled trial in patients from 16 intensive care units in Japan. Adult patients undergoing central venous or arterial catheter insertions were randomized to have one of three antiseptic solutions applied during catheter insertion and dressing changes. The primary endpoint was the incidence of catheter colonization, and the secondary endpoint was the incidence of catheter-related bloodstream infections (CRBSI). Of 1132 catheters randomized, 796 (70%) were included in the full analysis set. Catheter-tip colonization incidence was 3.7, 3.9, and 10.5 events per 1000 catheter-days in 0.5% CHG, 1% CHG, and PVI groups, respectively (p = 0.03). Pairwise comparisons of catheter colonization between groups showed a significantly higher catheter colonization risk in the PVI group (0.5% CHG vs. PVI: hazard ratio, HR 0.33 [95% confidence interval, CI 0.12–0.95], p = 0.04; 1.0% CHG vs. PVI: HR 0.35 [95% CI 0.13–0.93], p = 0.04). Sensitivity analyses including all patients by multiple imputations showed consistent quantitative conclusions (0.5% CHG vs. PVI: HR 0.34, p = 0.03; 1.0% CHG vs. PVI: HR 0.35, p = 0.04). No significant differences were observed in the incidence of CRBSI between groups. Both 0.5% and 1.0% alcohol CHG are superior to 10% aqueous PVI for the prevention of intravascular catheter colonization. Japanese Primary Registries Network; No.: UMIN000008725 Registered on 1 September 2012 The online version of this article (doi:10.1186/s13054-017-1890-z) contains supplementary material, which is available to authorized users.
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