乙醇封管疗法（E-Lock）预防心脏大手术后导管相关血流感染（CR-BSI）：一项随机临床试验。
Ethanol lock therapy (E-Lock) in the prevention of catheter-related bloodstream infections (CR-BSI) after major heart surgery (MHS): a randomized clinical trial.
作者信息
Pérez-Granda María Jesús, Barrio José María, Muñoz Patricia, Hortal Javier, Rincón Cristina, Rabadán Pablo Martin, Pernia Maria Sagrario, Bouza Emilio
机构信息
Department of Anesthesiology, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
Department of Clinical Microbiology and Infectious Diseases, School of Medicine, Universidad Complutense, Madrid, Spain; Medicine Department, School of Medicine, Universidad Complutense, Madrid, Spain; Instituto de Investigación Biomédica Gregorio Marañón, Madrid, Spain; CIBER Enfermedades Respiratorias-CIBERES (CB06/06/0058), Madrid, Spain.
出版信息
PLoS One. 2014 Mar 27;9(3):e91838. doi: 10.1371/journal.pone.0091838. eCollection 2014.
BACKGROUND
Lock-therapy with antimicrobials has been used for the treatment and prevention of catheter-related bloodstream infections (CR-BSI). Experiences with Ethanol-Locks (E-locks) have included therapeutic interventions with variable results. Patients undergoing Major Heart Surgery (MHS) are a high-risk population for CR-BSI.The aim of this study was to assess the efficacy and tolerance to E-Locks in the prevention of CR-BSI of patients undergoing MHS.
METHODS AND FINDINGS
This is an academic, prospective, randomized, non-blinded and controlled clinical trial assessing the incidence of CR-BSI of patients with E-locks (E-lock) and the tolerance to the procedure in comparison with patients receiving conventional catheter-care (CCC). Patients undergoing MHS with intravascular catheters for more than 48 hours were randomly assigned into treatment or control group by a computer-generated list of randomly assigned numbers. In the treatment group, all their catheter lumens were locked with an ethanol solution at 70% for two hours, every three days (E-Locks). The control group received conventional catheter-care (CCC). Overall, 200 patients with 323 catheters were included in the study, which was stopped after 10 months due to adverse events. Of them, 179 catheters (113 patients) had E-Locks and 144 catheters (87 patients) were CCC. Euroscore Surgical Risk in both groups was 4.04 vs 4.07 p = 0.94 respectively. The results for the E-Locks and CCC were as follows: Incidence of CR-BSI/1000 days of exposure 2.1 vs 5.2 (p = 0.33), catheter tip colonization 14 (7.8%) vs 6 (4.2%) patients (p = 0.17), median length of hospital stay, 15 vs 16 days (p = 0.77). Seven patients (6.19%), all in the ethanol branch, had to discontinue the trial due to intolerance or adverse events.
CONCLUSIONS
We do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery.
TRIAL REGISTRATION
Clinical Trials.gov NCT01229592.
背景
使用含抗菌药物的封管疗法已用于治疗和预防导管相关血流感染（CR-BSI）。乙醇封管（E-locks）的经验包括不同结果的治疗干预措施。接受心脏大手术（MHS）的患者是发生CR-BSI的高危人群。本研究的目的是评估E-locks预防MHS患者CR-BSI的疗效和耐受性。
方法和结果
这是一项学术性、前瞻性、随机、非盲法和对照临床试验，评估接受E-locks治疗的患者（E-lock组）CR-BSI的发生率以及与接受传统导管护理（CCC）的患者相比对该操作的耐受性。接受MHS且血管内导管留置超过48小时的患者通过计算机生成的随机分配数字列表随机分为治疗组或对照组。治疗组中，其所有导管腔每三天用70%乙醇溶液封管两小时（E-locks）。对照组接受传统导管护理（CCC）。总体而言，本研究纳入了200例患者的323根导管，由于不良事件，10个月后研究终止。其中，179根导管（113例患者）采用E-locks，144根导管（87例患者）采用CCC。两组的欧洲心脏手术风险评分分别为4.04和4.07，p = 0.94。E-locks组和CCC组的结果如下：每1000天暴露的CR-BSI发生率分别为2.1和5.2（p = 0.3），导管尖端定植患者分别为14例（7.8%）和6例（4.2%）（p = 0.17），中位住院时间分别为15天和16天（p = 0.77）。7例患者（6.19%），均在乙醇组，因不耐受或不良事件不得不中止试验。
结论
我们不建议对接受心脏大手术的患者常规使用乙醇封管预防CR-BSI。
试验注册
ClinicalTrials.gov NCT01229592
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