Modified Quick Change Method for Norepinephrine Syringe Exchange in Critically Ill Patients: A Quasi-randomized, Non-inferiority Trial.

Background: This study aimed to verify that the modified quick change (mQC) method of syringe exchange in critically ill patients receiving a continuous intravenous norepinephrine infusion is not inferior to the conventional double pumping (DP) method.

Methods: This non-blinded, quasi-randomized, non-inferiority trial was conducted in a single hospital from August 1, 2023 to February 29, 2024. Adult patients aged 18 years or older who were admitted to the emergency ward and received a continuous intravenous norepinephrine infusion were eligible for inclusion. This study utilized a convenience sample of all eligible patients admitted during the study period. Patients were allocated to the mQC group or the DP group based on their month of admission. The primary endpoint was defined as the difference between the minimum mean arterial pressure during the 10 minutes after norepinephrine exchange and the mean arterial pressure before exchange. Non-inferiority was established if the lower limit of the 95% confidence interval was within the prespecified margin of 10 mm Hg.

Results: Thirteen patients in the mQC group and eight in the DP group were analyzed. The mean value of the primary endpoint was -8.92 mm Hg in the mQC group and -10.63 mm Hg in the DP group. The 95% confidence interval for the difference between the two groups ranged from 0 mm Hg to 8.50 mm Hg, which was within the prespecified margin. Therefore, the non-inferiority of the mQC method was confirmed.

Conclusion: The mQC method of syringe exchange was not inferior to the DP method in critically ill patients receiving a continuous intravenous norepinephrine infusion. Given its comparable safety profile and simpler procedure, the mQC method has the potential to become a standard exchange technique. However, future large-scale randomized controlled trials are required to verify our findings.