Multicenter clinical trial results with the LifeSite hemodialysis access system.
Multicenter clinical trial results with the LifeSite hemodialysis access system.
复制标题
LifeSite 血液透析接入系统的多中心临床试验结果。
DOI：
10.1046/j.1523-1755.2002.00540.x
复制
发表时间：
2002
影响因子：
19.6
通讯作者：
John Moran
中科院分区：
文献类型：
--
作者：
S. Schwab;M. Weiss;Fred Rushton;J. P. Ross;Jerry W. Jackson;T. Kapoian;James Yegge;M. Rosenblatt;W. Reese;R. Soundararajan;J. Work;J. Ross;B. Stainken;A. Pedan;John Moran
背景
LifeSite血液透析入路系统是一种皮下入路器械，旨在最大限度地增加血流量，同时最大限度地减少入路相关并发症。本研究的目的是比较LifeSite系统与相似但经皮穿刺器械（Tesio-Cath血液透析导管）的有效性和安全性。
方法
研究分两个阶段进行。第一阶段（第1阶段）采用多中心随机前瞻性设计，Tesio-Cath组招募了34名患者，LifeSite组招募了36名患者，其中使用0.2%羟氯酸钠作为LifeSite的抗菌溶液。随后进行了非随机化但其他方面相同的第二阶段研究，其中使用70%异丙醇溶液作为另外34名LifeSite患者的抗菌溶液（第2阶段）。
结果
在试验的第1阶段评价了器械功能。LifeSite组的实际血流量（通过超声稀释确定）大于Tesio-Cath组（358.7 vs. 331.8 mL/min，P < 0.001，机器指示血流量为400 mL/min）。对试验第1期和第2期的所有三组进行了感染比较; Tesio导管、LifeSite系统（含羟氯丙烷）和LifeSite系统（含70%异丙醇）。器械相关感染定义为全身性菌血症，无其他明显的起源部位和出口部位感染，需要全身性抗生素或器械取出。这表明LifeSite酒精组每1000器械使用日的感染率为1.3，Tesio-Cath组为3.3，LifeSite羟氯丙烷组为3.4。Tesio-Cath和LifeSite羟氯丙烷组之间的器械相关感染率无统计学显著差异。LifeSite酒精组感染率与其他两组比较差异有统计学意义（P < 0.05）。器械血栓形成定义为需要滴注溶栓药物以维持血流>300 mL/min。LifeSite氧氯沙星组和Tesio-Cath组之间的溶栓输注需求没有差异（P = 0.1496）;但是，在此情况下，LifeSite酒精组需要的溶栓输注显著少于Tesio-Cath组（P = 0.0295），以维持足够的血流。按糖尿病状态分层并调整年龄后，LifeSite酒精组（89.9%）的6个月器械存活率显著优于LifeSite羟氯乙醇组（64.8%，P = 0.0286）和Tesio-Cath组（69.1%，P = 0.0292）。
结论
LifeSite血液透析入路系统与70%异丙醇作为抗菌溶液一起使用时，与标准套囊隧道式血液透析导管相比，具有更低的感染率和更好的器械存活率。
BACKGROUND
The LifeSite Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath Hemodialysis Catheter.
METHODS
The study was conducted in two phases. A multi-center randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2).
RESULTS
Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow>300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group.
CONCLUSIONS
The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.