Randomized pilot study to compare metal needles versus plastic cannulae in the development of complications in hemodialysis access.

BACKGROUND: Hemodialysis requires needle insertions every treatment. Needle injury (mechanical or hemodynamic) may cause complications (aneurysms/stenosis) that compromise dialysis delivery requiring interventions. Metal needles have a sharp slanted "V"-shaped cutting tip; plastic cannulae have a dull round tip and four side holes. Preliminary observations demonstrated a difference in intradialytic blood flow images and mean Doppler velocities at cannulation sites between the two devices. Complications from mechanical and hemodynamic trauma requiring interventions were compared in each group.

MATERIALS AND METHODS: In all, 33 patients (13 females and 17 new accesses) were randomized to metal group (n = 17) and plastic group (n = 16). Mechanical trauma was minimized by having five nurses performing ultrasound-guided cannulations. Complications were identified by the clinician and addressed by the interventionalists, both blinded to study participation. Patients were followed for up to 12 months.

RESULTS: Baseline characteristics were not significant. Procedures to treat complications along cannulation segments increased from 0.41 to 1.29 per patient (metal group) and decreased from 1.25 to 0.69 per patient (plastic group; p = 0.004). The relative risks of having an intervention (relative risk = 1.5, 95% confidence interval = 0.88-2.67) and having an infiltration during hemodialysis (relative risk = 2.26, 95% confidence interval = 1.03-4.97) were higher for metal needles. Time to first intervention trended in favor of plastic cannula (p = 0.069). Cost of supplies for these interventions was approximately CAD$20,000 lower for the plastic group.

CONCLUSION: Decreased burden of illness related to cannulation (less infiltrations during hemodialysis) and Qb were associated with plastic cannulae. Decreased procedure costs were suggested during the study period in the plastic group.