Needle-free connectors in tunneled central venous catheters for hemodialysis: A prospective single-centre safety and feasibility study

Background: Tunnelled central venous catheters (t-CVCs) remain essential for hemodialysis when arteriovenous access is not feasible, but catheter-related bloodstream infection (CRBSI) is a major risk. In temporary CVCs, needle-free connectors have been associated with fewer infections; however, data on high-flow hemodialysis catheters are limited. We evaluated the short-term safety and feasibility of high-flow split-septum needle-free connectors on hemodialysis temporary central venous catheters (t-CVCs). Methods: In a prospective single-centre study (Trbovlje General Hospital, Slovenia; June 2025), adults with a mature t-CVC used for thrice-weekly hemodialysis and without signs of infection were enrolled. Split-septum needle-free connectors (Asset-FlowArt®-1010H-S) with antibacterial caps were applied to both hubs and used for 12 consecutive dialysis sessions per patient. The primary outcome was microbiological safety, defined as negativity of paired blood cultures after 12 sessions. Secondary outcomes included clinical tunnel infection, change in inflammatory markers, need to modify dialysis prescription/anticoagulation/catheter care, mechanical complications, hospitalization, and death. Results: Fifteen patients completed 12 sessions each (total 180 sessions). Paired blood cultures were negative at baseline and after 12 sessions in all patients. No tunnel infections occurred. There were no meaningful changes in inflammatory markers, and no device-related adverse events or protocol modifications were required. No hospitalizations or deaths occurred during follow-up. Flow performance supported prescribed blood-flow rates. Conclusion: In this short-term single-centre cohort, high-flow split-septum needle-free connectors appeared feasible and microbiologically safe on hemodialysis t-CVCs, without compromising dialysis delivery or routine catheter care. Larger, multicenter randomized trials with longer follow-up are warranted to determine effects on CRBSI incidence and catheter patency.