碳酸氢钠与肝素作为维持性血液透析患者隧道式中心静脉导管封管液的疗效比较随机对照试验
A Randomized Controlled Trial of Comparative Efficacy between Sodium Bicarbonate and Heparin as A Locking Solution for Tunneled Central Venous Catheters Among Patients Requiring Maintenance Hemodialysis.
作者信息
Wathanavasin Wannasit, Phannajit Jeerath, Poosoonthornsri Manorom, Lewsuwan Songkiat, Tanateerapong Patchara, Chongthanakorn Kamonrat, Takkavatakarn Kullaya, Katavetin Pisut, Tiranathanagul Khajohn, Eiam-Ong Somchai, Susantitaphong Paweena
机构信息
Division of Nephrology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand.
Nephrology unit, Department of Medicine, Charoenkrung Pracharak Hospital, Bangkok, Thailand.
出版信息
Can J Kidney Health Dis. 2021 Sep 30;8:20543581211046077. doi: 10.1177/20543581211046077. eCollection 2021.
BACKGROUND
Sodium bicarbonate (NaHCO) is one of the promising solutions that has good safety profile and theoretical advantages regarding antimicrobial and antithrombotic properties but there are still limited reports.
OBJECTIVE
To compare the efficacy in lowering rate of catheter loss due to catheter-related thrombosis (CRT) or catheter-related blood stream infection (CRBSI) between sodium bicarbonate and heparin lock in prevalent chronic hemodialysis (HD) patients.
DESIGN
A multicenter, randomized, open-label study.
SETTING
In a developing country, Thailand.
PATIENTS
Chronic HD patients with tunneled central venous catheter.
MEASUREMENTS
Catheter loss rate, rate of catheter-related blood stream infection, catheter-related thrombosis, and exit site or tunnel infection.
METHODS
The prospective multicenter randomized controlled trial was conducted, we randomly assigned 118 patients undergoing HD with tunneled central venous catheter to receive a catheter locking solution of sodium bicarbonate or heparin. The primary outcome was a catheter loss rate due to CRT or CRBSI, while the secondary outcome was a composite outcome of CRT, CRBSI, or exit site/tunnel infection (ESI/TI).
RESULTS
The present study was stopped early due to an excess of catheter-related thrombosis in the sodium bicarbonate group. From the first 6 weeks of follow-up, there were no catheter losses due to CRT or CRBSI in both groups. The sodium bicarbonate group had a significantly higher rate of the secondary composite outcomes and this was entirely caused by CRT with the median time to thrombosis of 23.6 days. Every CRT event could be successfully rescued by using a single dose of recombinant tissue plasminogen activator (rt-PA).
LIMITATIONS
Short follow-up period.
CONCLUSIONS
In prevalent HD patients with tunneled CVCs, use of a sodium bicarbonate locking solution for prevention of CRT is inferior to heparin and is associated with a high rate of catheter-related thrombosis.
TRIAL REGISTRATION
The study was registered with the Thai Clinical Trials Registry TCTR 20200610003.
背景
碳酸氢钠（NaHCO）是一种前景良好的溶液，具有良好的安全性，在抗菌和抗血栓形成特性方面具有理论优势，但相关报道仍然有限。
目的
比较碳酸氢钠与肝素封管在慢性血液透析（HD）患者中降低因导管相关血栓形成（CRT）或导管相关血流感染（CRBSI）导致的导管丢失率的疗效。
设计
一项多中心、随机、开放标签研究。
地点
在发展中国家泰国。
患者
带隧道式中心静脉导管的慢性HD患者。
测量指标
导管丢失率、导管相关血流感染率、导管相关血栓形成率以及出口部位或隧道感染率。
方法
进行了前瞻性多中心随机对照试验，我们将118例接受带隧道式中心静脉导管血液透析的患者随机分配，使其接受碳酸氢钠或肝素的导管封管溶液。主要结局是因CRT或CRBSI导致的导管丢失率，次要结局是CRT、CRBSI或出口部位/隧道感染（ESI/TI）的复合结局。
结果
由于碳酸氢钠组导管相关血栓形成过多，本研究提前终止。在随访的前6周，两组均未出现因CRT或CRBSI导致的导管丢失。碳酸氢钠组次要复合结局的发生率显著更高，这完全是由CRT导致的，血栓形成的中位时间为23.6天。每例CRT事件均可通过使用单剂量重组组织型纤溶酶原激活剂（rt-PA）成功挽救。
局限性
随访期短。
结论
在患有带隧道式中心静脉导管的慢性HD患者中，使用碳酸氢钠封管溶液预防CRT不如肝素，且与较高的导管相关血栓形成率相关。
试验注册
该研究已在泰国临床试验注册中心TCTR 20200610003注册。
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