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枸橼酸钠与肝素用于带 cuff 的中心静脉导管封管的比较:一项单中心随机对照试验。

Sodium citrate versus heparin catheter locks for cuffed central venous catheters: a single-center randomized controlled trial.

作者信息

Power Albert, Duncan Neill, Singh Seema K, Brown Wendy, Dalby Elizabeth, Edwards Claire, Lynch Kathleen, Prout Virginia, Cairns Tom, Griffith Megan, McLean Adam, Palmer Andrew, Taube David

机构信息

Haemodialysis Research Group, Imperial College Kidney and Transplant Institute, West London Renal and Transplant Centre, Hammersmith Hospital, London, UK.

出版信息

Am J Kidney Dis. 2009 Jun;53(6):1034-41. doi: 10.1053/j.ajkd.2009.01.259. Epub 2009 Apr 25.

Abstract

BACKGROUND

Sodium citrate has antibacterial and anticoagulant properties that are confined to the catheter when used as a catheter lock. Studies of its use as a catheter lock have suggested its efficacy in preventing infection and bleeding complications compared with sodium heparin.

STUDY DESIGN

Open-label randomized controlled trial of 2 catheter locks to examine the hypothesis that sodium citrate catheter locks will reduce catheter-related bacteremia and exit-site infection.

SETTINGS & PARTICIPANTS: 232 consenting long-term hemodialysis patients in 4 satellite dialysis units to a large dialysis program with protocolized treatment and targets. All patients were using twin-catheter single-lumen Tesio-Caths (MedComp, Harleysville, PA).

INTERVENTION

6 months' use of 46.7% sodium citrate (citrate) or 5% heparin (heparin) locked postdialysis in the dead space of the central venous catheter.

OUTCOMES & MEASUREMENTS: Primary end point of catheter-related bacteremia and exit-site infection. Secondary end points of catheter thrombosis defined by the use of urokinase lock and infusion, new catheter insertion, catheter-related admission, blood transfusions, parenteral iron, and erythropoietin requirements.

RESULTS

Catheter-related bacteremia did not differ in the 2 groups, with an incidence of 0.7 events/1,000 catheter-days. There was no significant difference in rates of exit-site infection (0.7 versus 0.5 events/1,000 catheter-days; P = 0.5). The secondary end point of catheter thrombosis defined by the use of a urokinase lock was significantly more common in the citrate group, with an incidence of 8 versus 4.3/1,000 catheter-days (P < 0.001). Other secondary end points did not differ. Citrate treatment was curtailed compared with heparin because of a greater incidence of adverse events, with a mean treatment duration before withdrawal of 4.8 +/- 2.0 versus 5.7 +/- 1.2 months, respectively (P < 0.001).

LIMITATIONS

Low baseline catheter-related bacteremia and exit-site infection event rates may have underpowered this study. High adverse-event rates may have been related to high-concentration citrate that led to increased overspill and reduction in lock volume. This may also explain the increased rates of thrombosis in this group.

CONCLUSION

Widespread and long-term use of 46.7% citrate catheter locks with Tesio-Cath access is not justified by this study.

摘要

背景

柠檬酸钠具有抗菌和抗凝特性,用作导管封管液时其作用局限于导管。有关其作为导管封管液使用的研究表明,与肝素钠相比,它在预防感染和出血并发症方面有效。

研究设计

对两种导管封管液进行开放标签随机对照试验,以检验柠檬酸钠导管封管液可减少导管相关菌血症和出口部位感染这一假设。

设置与参与者

4个卫星透析单元的232名同意参与的长期血液透析患者,这些单元隶属于一个采用标准化治疗和目标的大型透析项目。所有患者均使用双导管单腔Tesio导管(MedComp,宾夕法尼亚州哈雷斯维尔)。

干预措施

透析后在中心静脉导管的死腔内使用46.7%柠檬酸钠(柠檬酸盐)或5%肝素(肝素)封管6个月。

结果与测量指标

导管相关菌血症和出口部位感染的主要终点。导管血栓形成的次要终点,通过使用尿激酶封管和输注、新导管插入、与导管相关的入院治疗、输血、胃肠外铁剂以及促红细胞生成素需求来定义。

结果

两组的导管相关菌血症无差异,发生率为0.7次事件/1000导管日。出口部位感染率无显著差异(0.7比0.5次事件/1000导管日;P = 0.5)。使用尿激酶封管定义的导管血栓形成次要终点在柠檬酸盐组中明显更常见,发生率为8比4.3/1000导管日(P < 0.001)。其他次要终点无差异。与肝素相比,柠檬酸盐治疗因不良事件发生率更高而提前终止,撤药前的平均治疗持续时间分别为4.8±2.0个月和5.7±1.2个月(P < 0. I 001)。

局限性

较低的基线导管相关菌血症和出口部位感染事件发生率可能使本研究的效力不足。高不良事件发生率可能与高浓度柠檬酸盐导致溢出增加和封管液体积减少有关。这也可能解释了该组血栓形成率增加的原因。

结论

本研究表明,Tesio导管通路广泛长期使用46.7%柠檬酸盐导管封管并不合理。

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