Department of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China.
Department of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, China
BMJ Open. 2024 Sep 20;14(9):e079302. doi: 10.1136/bmjopen-2023-079302.
In addition to various techniques involved in catheter insertion, catheter placement location, lumen diameter and operation and management during continuous renal replacement therapy (CRRT), the design of the tip and side holes, as well as the position of the tip of the catheter, can also impact catheter function. Side-hole and step-tip catheters are commonly used during CRRT. However, there is insufficient evidence comparing their efficacy for CRRT in critically ill patients. And the optimal position of the tip of catheters is not well studied and remains controversial. This study was conducted to assess whether using a step-tip catheter could reduce the rate of catheter dysfunction compared with a side-hole catheter and whether inserting a longer catheter could reduce the incidence of catheter dysfunction and increase catheter survival time.
A prospective, open-label, three-arm, parallel-group, single-centre randomised controlled trial will be conducted at West China Hospital of Sichuan University in China. An estimated sample of 378 participants receiving CRRT treatment will be recruited. Eligible patients will be randomly assigned to three groups to receive different dialysis catheters for the initiation of CRRT at a 1:1:1 ratio via a central randomisation system: group A, side-hole catheters (11Fr, 200 mm; GDHK-1120; Baxter International Inc., Deerfield, Illinois); group B, step-tip catheters (13Fr, 200 mm; GDHK-1320; Baxter International Inc.) and group C, step-tip catheters (13Fr, 250 mm; GDHK-1325; Baxter International Inc.). The femoral vein is the only vascular access. All catheters will be inserted under the guidance of ultrasound using the Seldinger method to reduce complications and trauma related to catheter insertion. The primary outcomes are the occurrence of catheter dysfunction and catheter survival time. Outcome assessors and data analysts will be blinded. All data will be analysed according to the group randomly assigned by an intention-to-treat analysis, in which catheters with missing data for the primary outcomes would be excluded.
The trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2023.1221). And the results will be published in peer-reviewed journals.
ChiCTR2300075107.
除了导管插入的各种技术外，导管的放置位置、管腔直径以及连续性肾脏替代治疗（CRRT）期间的操作和管理，导管尖端和侧孔的设计以及导管尖端的位置也会影响导管的功能。CRRT 中通常使用侧孔和阶梯尖端导管。然而，目前尚缺乏比较危重症患者使用这两种导管进行 CRRT 的疗效的证据。并且导管尖端的最佳位置也没有得到很好的研究，仍然存在争议。本研究旨在评估与侧孔导管相比，使用阶梯尖端导管是否可以降低导管功能障碍的发生率，以及插入更长的导管是否可以降低导管功能障碍的发生率并延长导管的存活时间。
这是一项在中国四川大学华西医院进行的前瞻性、开放标签、三臂、平行组、单中心随机对照试验。预计将招募 378 名接受 CRRT 治疗的参与者。符合条件的患者将通过中央随机系统以 1:1:1 的比例随机分配到三组，以接受不同的透析导管开始 CRRT：组 A，侧孔导管（11Fr，200mm；GDHK-1120；Baxter International Inc.，伊利诺伊州迪尔菲尔德）；组 B，阶梯尖端导管（13Fr，200mm；GDHK-1320；Baxter International Inc.）和组 C，阶梯尖端导管（13Fr，250mm；GDHK-1325；Baxter International Inc.）。股静脉是唯一的血管通路。所有导管均在超声引导下使用 Seldinger 法插入，以减少与导管插入相关的并发症和创伤。主要结局是导管功能障碍的发生和导管的存活时间。结局评估者和数据分析师将被设盲。所有数据将根据意向治疗分析随机分配的组进行分析，其中主要结局缺失数据的导管将被排除。
该试验方案已获得四川大学华西医院生物医学研究伦理委员会的批准（2023.1221）。结果将发表在同行评议的期刊上。
ChiCTR2300075107。
