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Background <p>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.</p> Methods <p>In this open-label, three-arm, randomized trial, critically ill patients receiving CRRT were randomized to three groups. Group A received 20&#xa0;cm side-hole catheters (GDHK‐1120), group B received 20&#xa0;cm step-tip catheters (GDHK‐1320) and group C received 25&#xa0;cm step-tip catheters (GDHK‐1325). The primary outcomes were the incidence of catheter dysfunction and catheter survival time.</p> Results <p>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) (<i>P</i> = 0.001). However, there was no difference between group B and group C (15.6%, 23/147) (<i>P</i> = 0.744). The catheter survival time was comparable between group A (5.5&#xa0;days, IQR 2.5–9.3) and group B (5.0&#xa0;days, IQR 3.0–10.0) (<i>P</i> = 0.626). In contrast, group C (6.4&#xa0;days, IQR 3.9–12.0) demonstrated a significantly longer catheter survival time compared to group B (<i>P</i> = 0.019). Cox regression analysis identified BMI (HR 1.052, 95% CI 1.003–1.103, <i>P</i> = 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 &lt; 24.2) (chi-square 13.65, <i>P</i> = 0.001). There was also a trend that patients in group C have a longer filter lifespan (36.5&#xa0;h, IQR 16.9–68.1, <i>P</i> = 0.001) and a lower incidence of catheter-related thrombosis (10.40 per 1000 catheter-days, 95% CI 5.93, 17.83, <i>P</i> = 0.019). Other secondary outcomes were not significantly different among groups.</p> Conclusions <p>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.</p> <p><i>Trial registration</i>: ChiCTR2300075107. Registered 25 August 2023.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月11日

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

摘要

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.