The SILVER (Silver Impregnated Line Versus EVD Randomized Trial): A Double-Blind, Prospective, Randomized, Controlled Trial of an Intervention to Reduce the Rate of External Ventricular Drain Infection
The SILVER (Silver Impregnated Line Versus EVD Randomized Trial): A Double-Blind, Prospective, Randomized, Controlled Trial of an Intervention to Reduce the Rate of External Ventricular Drain Infection
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DOI：
10.1227/neu.0b013e318257bebb
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发表时间：
2012-08-01
期刊：
影响因子：
4.8
通讯作者：
Kirkpatrick, Peter J.
中科院分区：
文献类型：
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作者：
Keong, Nicole Chwee Har;Bulters, Diederik Olivier;Kirkpatrick, Peter J.
背景：与脑室外引流（EVD）放置相关的脑脊液（CSF）感染会带来严重后果。导管中的银浸渍试图减少感染。目的：评估银导管对抗脑脊液感染的功效。方法：我们进行了一项涉及 2 个神经外科中心的随机对照试验（2005 年 6 月至 2009 年 9 月）。总共 356 名需要 EVD 的患者接受了资格评估； 325 名患者被纳入并随机分组（167 名普通患者，158 名银患者）；对 278 名患者进行了分析（140 名普通患者，138 名银患者）。主要结果指标是脑脊液感染，定义为革兰氏染色上观察到的或通过培养分离的生物体。次要结果指标包括脑室腹腔 (VP) 分流。 结果：两个研究组之间的感染风险存在显着差异：普通导管为 21.4% (30/140)，银导管为 12.3% (17/138)（P = 0.0427；95% 置信区间 [CI]：1.015-3.713）。与未感染 EVD 的患者相比，感染 EVD 的患者需要 VP 分流的风险增加一倍以上（分别为 45.7% [21/46] 和 19.7% [45/229]，P = .0002；95% CI：1.766-6.682）。感染引起的 VP 分流风险也存在显着差异：普通组 (55.2%；16/29) 与银组 (29.4%；5/17)； P = .0244（95% CI：1.144-11.695）。多变量分析表明，感染风险随 EVD 放置时间（比值比：1.160）、自发性颅内出血（比值比 4.958）而增加，而银导管则降低感染风险（比值比：0.423）。 结论：该研究提供了 I 类证据，表明银浸渍导管可减少脑脊液感染。
BACKGROUND: Cerebrospinal fluid (CSF) infections associated with external ventricular drain (EVD) placement attract major consequences. Silver impregnation of catheters attempts to reduce infection.OBJECTIVE: To assess the efficacy of silver catheters against CSF infection.METHODS: We performed a randomized, controlled trial involving 2 neurosurgical centers (June 2005 to September 2009). A total of 356 patients requiring an EVD were assessed for eligibility; 325 patients were enrolled and randomized (167 plain, 158 silver); 278 patients were analyzed (140 plain, 138 silver). The primary outcome measure was CSF infection as defined by organisms seen on Gram stain or isolated by culture. Secondary outcome measures included ventriculoperitoneal (VP) shunting.RESULTS: There was a significant difference in infection risk between the 2 study arms: 21.4% (30/140) for plain catheters vs 12.3% (17/138) for silver catheters (P = .0427; 95% confidence interval [CI]: 1.015-3.713). Patients who had an EVD infection had more than double the risk of requiring a VP shunt compared with patients without an EVD infection (45.7% [21/46] vs 19.7% [45/229], respectively, P = .0002; 95% CI: 1.766-6.682). There was also a significant difference in VP shunt risk with infection: plain (55.2%; 16/29) vs the silver arm (29.4%; 5/17); P = .0244 (95% CI: 1.144-11.695). A multivariate analysis demonstrated that infection risk was increased by duration of EVD placement (odds ratio: 1.160), spontaneous intracranial hemorrhage (odds ratio 4.958) and decreased by silver catheters (odds ratio: 0.423).CONCLUSION: The study provides Class I evidence that silver-impregnated catheters reduce CSF infection.