Comparison of side-hole and step-tip catheters for patients requiring continuous renal replacement therapy in intensive care units: study protocol for a randomised controlled trial.

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

ChiCTR2300075107.