Simon Fraser University, Burnaby, Canada.
Center for Health Evaluation and Outcome Sciences, University of British Columbia, Vancouver, Canada.
Trials. 2022 Aug 30;23(1):719. doi: 10.1186/s13063-022-06671-5.
Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to complications such as bacterial biofilm production and colonization, catheter-related bloodstream infection, occlusion, and catheter-related venous thrombosis. A CVAD is among the most common interventions for patients in the intensive care unit (ICU), exposing this vulnerable population to the risk of nosocomial infection and catheter occlusion. The current standard of care involves the use of normal saline as a catheter locking solution for central venous catheters (CVCs) and peripherally inserted central catheter (PICC) lines, and a citrate lock for hemodialysis catheters. Saline offers little prophylactic measures against catheter complications. Four percent of tetrasodium ethylenediaminetetraacetic acid (EDTA) fluid (marketed as KiteLock Sterile Locking Solution™) is non-antibiotic, possesses antimicrobial, anti-biofilm, and anti-coagulant properties, and is approved by Health Canada as a catheter locking solution. As such, it may be a superior CVAD locking solution than the present standard of care lock in the ICU patient population.
Our team proposes to fill this knowledge gap by performing a multi-center, cluster-randomized, crossover trial evaluating the impact of 4% tetrasodium EDTA on a primary composite outcome of the incidence rate of central line-associated bloodstream infection (CLABSI), catheter occlusion leading to removal, and use of alteplase to resolve catheter occlusion compared to the standard of care. The study will be performed at five critical care units.
If successful, the results of this study can serve as evidence for a shift of standard of care practices to include EDTA locking fluid in routine CVAD locking procedures. Completion of this study has the potential to improve CVAD standard of care to become safer for patients, as well as provides an opportunity to decrease strain on healthcare budgets related to treating preventable CVAD complications. Success and subsequent implementation of this intervention in the ICU may also be extrapolated to other patient populations with heavy CVAD use including hemodialysis, oncology, parenteral nutrition, and pediatric patient populations. On a global scale, eradicating biofilm produced by antibiotic-resistant bacteria may serve to lessen the threat of "superbugs" and contribute to international initiatives supporting the termination of antibiotic overuse.
ClinicalTrials.gov NCT04548713, registered on September 9th, 2020.
中央静脉置管（CVAD）的插入使临床医生能够轻松进入患者循环系统，从而进行挽救生命的干预。由于其具有侵袭性，CVAD 容易发生细菌生物膜生成和定植、导管相关血流感染、阻塞和导管相关静脉血栓形成等并发症。CVAD 是重症监护病房（ICU）患者最常见的干预措施之一，使这一脆弱人群面临医院获得性感染和导管阻塞的风险。目前的护理标准包括使用生理盐水作为中央静脉导管（CVC）和外周插入中心导管（PICC）线的导管锁定溶液，以及柠檬酸锁定用于血液透析导管。生理盐水对导管并发症几乎没有预防措施。四钠乙二胺四乙酸（EDTA）溶液（以 KiteLock 无菌锁定溶液™销售）的 4%是非抗生素，具有抗菌、抗生物膜和抗凝血特性，并获得加拿大卫生部批准作为导管锁定溶液。因此，它可能是 ICU 患者人群中优于目前护理标准的 CVAD 锁定溶液。
我们的团队通过进行一项多中心、集群随机交叉试验来填补这一知识空白，该试验评估了 4%四钠 EDTA 对主要复合结局（中心静脉相关血流感染（CLABSI）的发生率、导致导管移除的导管阻塞以及使用阿替普酶解决导管阻塞）的影响，与标准护理相比。该研究将在五个重症监护病房进行。
如果成功，该研究结果可作为将 EDTA 锁定液纳入常规 CVAD 锁定程序的护理标准实践转变的证据。完成这项研究有可能使 CVAD 护理标准更安全，从而减少治疗可预防的 CVAD 并发症对医疗保健预算的压力。该干预措施在 ICU 中的成功实施和随后的实施也可能推广到其他大量使用 CVAD 的患者群体，包括血液透析、肿瘤学、肠外营养和儿科患者群体。在全球范围内，消除抗生素耐药细菌产生的生物膜可能有助于减轻“超级细菌”的威胁，并为支持终止抗生素过度使用的国际倡议做出贡献。
ClinicalTrials.gov NCT04548713，于 2020 年 9 月 9 日注册。
