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针对重症监护病房中需要持续肾脏替代治疗的患者,对不同尖端和长度的导管进行的一项随机对照试验。

A randomized controlled trial of catheters with different tips and lengths for patients requiring continuous renal replacement therapy in intensive care unit.

作者信息

Zhou Zhifeng, Liu Chen, Li Peiyun, Yang Yingying, Wang Fang, Xu Qing, Jin Lu, Zhang Ling, Fu Ping

机构信息

Department of Nephrology, Kidney Research Institute, West China Hospital of Sichuan University, Chengdu, 610041, China.

出版信息

Crit Care. 2025 Apr 11;29(1):148. doi: 10.1186/s13054-025-05389-5.

DOI:10.1186/s13054-025-05389-5
PMID:40217330
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11987356/
Abstract

BACKGROUND

The tip design and length of catheter impact catheter function. Two types of catheters with different tips, side-hole catheters and step-tip catheters, are commonly used during continuous renal replacement therapy (CRRT). However, there is insufficient evidence comparing their efficacy and safety in CRRT. In addition, whether the insertion of a longer catheter could enhance catheter function remains poorly studied and controversial.

METHODS

In this open-label, three-arm, randomized trial, critically ill patients receiving CRRT were randomized to three groups. Group A received 20 cm side-hole catheters (GDHK-1120), group B received 20 cm step-tip catheters (GDHK-1320) and group C received 25 cm step-tip catheters (GDHK-1325). The primary outcomes were the incidence of catheter dysfunction and catheter survival time.

RESULTS

A total of 351 patients were enrolled, with 116 in group A, 117 in group B, and 118 in group C. The incidence of catheter dysfunction in group A (35.7%, 51/143) was significantly higher than that in group B (17.7%, 22/124) (P = 0.001). However, there was no difference between group B and group C (15.6%, 23/147) (P = 0.744). The catheter survival time was comparable between group A (5.5 days, IQR 2.5-9.3) and group B (5.0 days, IQR 3.0-10.0) (P = 0.626). In contrast, group C (6.4 days, IQR 3.9-12.0) demonstrated a significantly longer catheter survival time compared to group B (P = 0.019). Cox regression analysis identified BMI (HR 1.052, 95% CI 1.003-1.103, P = 0.036) as an independent risk factor for catheter dysfunction. Results were not consistent across BMI tertiles, with similar results observed only in patients with a lower BMI (BMI < 24.2) (chi-square 13.65, P = 0.001). There was also a trend that patients in group C have a longer filter lifespan (36.5 h, IQR 16.9-68.1, P = 0.001) and a lower incidence of catheter-related thrombosis (10.40 per 1000 catheter-days, 95% CI 5.93, 17.83, P = 0.019). Other secondary outcomes were not significantly different among groups.

CONCLUSIONS

Step-tip catheters may be preferable for CRRT, particularly for patients in the lower BMI tercile. Longer femoral vein catheterization demonstrated enhanced benefits in CRRT, especially among obese patients. Further high-quality, multicenter RCTs are essential to strengthen the evidence guiding catheter selection during CRRT.

TRIAL REGISTRATION

ChiCTR2300075107. Registered 25 August 2023.

摘要

背景

导管的尖端设计和长度会影响导管功能。在连续性肾脏替代治疗(CRRT)期间,通常使用两种具有不同尖端的导管,即侧孔导管和阶梯尖端导管。然而,比较它们在CRRT中的疗效和安全性的证据不足。此外,插入更长的导管是否能增强导管功能仍研究不足且存在争议。

方法

在这项开放标签、三臂、随机试验中,接受CRRT的重症患者被随机分为三组。A组接受20厘米侧孔导管(GDHK - 1120),B组接受20厘米阶梯尖端导管(GDHK - 1320),C组接受25厘米阶梯尖端导管(GDHK - 1325)。主要结局是导管功能障碍的发生率和导管存活时间。

结果

共纳入351例患者,A组116例,B组117例,C组118例。A组导管功能障碍的发生率(35.7%,51/143)显著高于B组(17.7%,22/124)(P = 0.001)。然而,B组和C组之间无差异(15.6%,23/147)(P = 0.744)。A组(5.5天,IQR 2.5 - 9.3)和B组(5.0天,IQR 3.0 - 10.0)的导管存活时间相当(P = 0.626)。相比之下,C组(6.4天,IQR 3.9 - 12.0)的导管存活时间明显长于B组(P = 0.019)。Cox回归分析确定BMI(HR 1.052,95%CI为1.003 - 1.103,P = 0.036)是导管功能障碍的独立危险因素。结果在BMI三分位数中不一致,仅在BMI较低(BMI < 24.2)的患者中观察到类似结果(卡方值13.65,P = 0.001)。还有一个趋势是,C组患者的滤器使用寿命更长(36.5小时,IQR 16.9 - 68.1,P = 0.001),导管相关血栓形成的发生率更低(每1000导管日10.40,95%CI为5.93,17.83,P = 0.019)。其他次要结局在各组之间无显著差异。

结论

阶梯尖端导管可能更适合CRRT,特别是对于BMI较低三分位数的患者。更长的股静脉置管在CRRT中显示出更大的益处,尤其是在肥胖患者中。进一步的高质量、多中心随机对照试验对于加强指导CRRT期间导管选择的证据至关重要。

试验注册

ChiCTR2300075107。2023年8月25日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/d7d2b24109d0/13054_2025_5389_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/9c9258f0664b/13054_2025_5389_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/cdc8b8fa3dbc/13054_2025_5389_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/d7d2b24109d0/13054_2025_5389_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/9c9258f0664b/13054_2025_5389_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/cdc8b8fa3dbc/13054_2025_5389_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e47b/11987356/d7d2b24109d0/13054_2025_5389_Fig3_HTML.jpg

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2
Initial Clinical Experience with a Symmetric Tip Tunneled Hemodialysis Catheter Without Side Holes.无侧孔对称式隧道型带涤纶套血液透析导管的初步临床应用经验
ASAIO J. 2021 Nov 1;67(11):1257-1262. doi: 10.1097/MAT.0000000000001552.
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The SIF protocol: A seven-step strategy to minimize complications potentially related to the insertion of femorally inserted central catheters.
SIF 协议:一种将与经股置入中心静脉导管插入相关的潜在并发症降至最低的七步策略。
J Vasc Access. 2023 Jul;24(4):527-534. doi: 10.1177/11297298211041442. Epub 2021 Aug 29.
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Catheter-related blood stream infection in hemodialysis patients with symmetric tunneled non-side-hole hemodialysis catheters.使用对称隧道式无侧孔血液透析导管的血液透析患者的导管相关血流感染
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