Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.
Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.
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DOI：
10.1371/journal.pone.0010840
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发表时间：
2010-05-26
期刊：
影响因子：
3.7
通讯作者：
Rijnders BJ
中科院分区：
文献类型：
--
作者：
Slobbe L;Doorduijn JK;Lugtenburg PJ;El Barzouhi A;Boersma E;van Leeuwen WB;Rijnders BJ
导管相关性血流感染（CRBSI）导致显著的可归因发病率和死亡率。在这项随机、双盲、安慰剂对照试验中，我们研究了每日乙醇锁锁预防隧道中心静脉导管（CVC）患者CRBSI的有效性和安全性。从2005年到2008年，成人血液病患者CVC的每个管腔每天用70%乙醇或安慰剂锁定15分钟，然后将锁定溶液冲洗通过。作为主要终点，比较了腔内CRBSI的发生率。意向治疗分析基于376例患者，包括448例cvc和27,745个导管天数。对于乙醇锁组，每1000 cvc天的腔内CRBSI发生率为0.70(95%可信区间，0.4-1.3)，而安慰剂组为1.19(95%可信区间，0.7-1.9)（发生率比，0.59；95%可信区间，0.27-1.30;P = 0.19）。对于腔内CRBSI，根据最严格的定义（中心培养阳性和血液中相同的细菌菌株），接受乙醇治疗的患者观察到3.6倍的无显著性降低（226例中有2例对222例中有7例；P = 0.103）。未观察到危及生命的不良事件。更多接受乙醇治疗的患者停止了锁定治疗(226例中的11例对222例中的1例；P =。006)或继续降低锁定频率(226中的10对222中的0；P =。002)，由于非严重的不良事件。在本研究中，使用预防性乙醇锁对减少腔内CRBSI发生率的作用并不显著，尽管腔内CRBSI的低发生率使我们无法得出明确的结论。因此，缺乏统计显著性可能部分反映了缺乏权力。明显地，更多接受乙醇锁治疗的患者由于不良反应而停止预防性治疗，这些不良反应不严重，但与乙醇相关。应该在（腔内）CRBSI发生率较高的人群中进行进一步的研究。在我们的患者中，其他菌血症来源，如腔外CRBSI或化疗引起的粘膜炎期间的微生物易位可能更为重要。ClinicalTrials.gov NCT00122642
Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC). From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared. The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4–1.3), compared to 1.19 (95% confidence interval, 0.7–1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27–1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events. In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients. ClinicalTrials.gov NCT00122642
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