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随机对照试验氯己定敷料和高粘性敷料预防危重症成人导管相关感染。

Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults.

机构信息

Université Grenoble 1 (Joseph Fourrier)-U823 "Outcome of Cancers and Critical Illness," Albert Bonniot Institute, 38076, La Tronche, France.

出版信息

Am J Respir Crit Care Med. 2012 Dec 15;186(12):1272-8. doi: 10.1164/rccm.201206-1038OC. Epub 2012 Oct 4.

DOI:10.1164/rccm.201206-1038OC
PMID:23043083
Abstract

RATIONALE

Most vascular catheter-related infections (CRIs) occur extraluminally in patients in the intensive care unit (ICU). Chlorhexidine-impregnated and strongly adherent dressings may decrease catheter colonization and CRI rates.

OBJECTIVES

To determine if chlorhexidine-impregnated and strongly adherent dressings decrease catheter colonization and CRI rates.

METHODS

In a 2:1:1 assessor-masked randomized trial in patients with vascular catheters inserted for an expected duration of 48 hours or more in 12 French ICUs, we compared chlorhexidine dressings, highly adhesive dressings, and standard dressings from May 2010 to July 2011. Coprimary endpoints were major CRI with or without catheter-related bloodstream infection (CR-BSI) with chlorhexidine versus nonchlorhexidine dressings and catheter colonization rate with highly adhesive nonchlorhexidine versus standard nonchlorhexidine dressings. Catheter-colonization, CR-BSIs, and skin reactions were secondary endpoints.

MEASUREMENTS AND MAIN RESULTS

A total of 1,879 patients (4,163 catheters and 34,339 catheter-days) were evaluated. With chlorhexidine dressings, the major-CRI rate was 67% lower (0.7 per 1,000 vs. 2.1 per 1,000 catheter-days; hazard ratio [HR], 0.328; 95% confidence interval [CI], 0.174-0.619; P = 0.0006) and the CR-BSI rate 60% lower (0.5 per 1,000 vs. 1.3 per 1,000 catheter-days; HR, 0.402; 95% CI, 0.186-0.868; P = 0.02) than with nonchlorhexidine dressings; decreases were noted in catheter colonization and skin colonization rates at catheter removal. The contact dermatitis rate was 1.1% with and 0.29% without chlorhexidine. Highly adhesive dressings decreased the detachment rate to 64.3% versus 71.9% (P < 0.0001) and the number of dressings per catheter to two (one to four) versus three (one to five) (P < 0.0001) but increased skin colonization (P < 0.0001) and catheter colonization (HR, 1.650; 95% CI, 1.21-2.26; P = 0.0016) without influencing CRI or CR-BSI rates.

CONCLUSIONS

A large randomized trial demonstrated that chlorhexidine-gel-impregnated dressings decreased the CRI rate in patients in the ICU with intravascular catheters. Highly adhesive dressings decreased dressing detachment but increased skin and catheter colonization. Clinical trial registered with www.clinicaltrials.gov (NCT 01189682).

摘要

背景

大多数血管导管相关感染(CRI)发生在重症监护病房(ICU)的患者的导管外。氯己定浸渍和强粘性敷料可能会降低导管定植和 CRI 发生率。

目的

确定氯己定浸渍和强粘性敷料是否会降低导管定植和 CRI 发生率。

方法

在一项 2:1:1 比例的评估者盲法随机试验中,在 12 个 ICU 中接受预期持续时间为 48 小时或更长时间的血管导管插入的患者中,我们比较了氯己定敷料、高粘性敷料和标准敷料。主要终点是氯己定敷料与非氯己定敷料相比的主要 CRI 发生率(伴有或不伴有导管相关血流感染(CR-BSI))和高粘性非氯己定敷料与标准非氯己定敷料相比的导管定植率。导管定植、CR-BSI 和皮肤反应为次要终点。

测量和主要结果

共评估了 1879 例患者(4163 个导管和 34339 个导管日)。使用氯己定敷料时,主要 CRI 发生率降低了 67%(每 1000 个导管日 0.7 例 vs. 2.1 例;危险比[HR],0.328;95%置信区间[CI],0.174-0.619;P=0.0006),CR-BSI 发生率降低了 60%(每 1000 个导管日 0.5 例 vs. 1.3 例;HR,0.402;95%CI,0.186-0.868;P=0.02),而非氯己定敷料;在导管移除时,导管定植和皮肤定植率降低。接触性皮炎发生率为 1.1%(有氯己定)和 0.29%(无氯己定)。高粘性敷料将分离率降低至 64.3%(71.9%)(P<0.0001),每个导管的敷料数量减少至两个(一个至四个)(三个(一个至五个)(P<0.0001),但增加了皮肤定植(P<0.0001)和导管定植(HR,1.650;95%CI,1.21-2.26;P=0.0016),而不影响 CRI 或 CR-BSI 发生率。

结论

一项大型随机试验表明,氯己定凝胶浸渍敷料降低了 ICU 中接受血管内导管的患者的 CRI 发生率。高粘性敷料降低了敷料分离率,但增加了皮肤和导管定植率。临床试验在 www.clinicaltrials.gov(NCT 01189682)注册。

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