Optimizing the Priming Process for Hemoadsorption Combined with Hemodialysis: A Two-Stage in vitro and Clinical Validation Study.

Abstract

Introduction: Conventional priming for hemoadsorption combined with hemodialysis is complex, time-consuming, and resource-intensive. We aimed to develop and validate a standardized, efficient, and safe tandem priming protocol by systematically evaluating its operational efficiency, circuit cleanliness, clinical efficacy, and clinical safety.

Methods: A two-stage "in vitro screening - clinical validation" design was utilized, using the HA130 hemoadsorption cartridge (Jafron, China) throughout all experiments and clinical sessions. The in vitro phase compared four novel tandem priming methods (varying slow-prime flow rates and fast-flush volumes) against a traditional separate-priming method to identify an optimal protocol based on efficiency and cleanliness. This protocol was then validated in a single-center, single-blind randomized controlled trial involving 53 maintenance hemodialysis patients randomized to the optimized tandem method (n = 29) or the traditional method (n = 24). The primary safety outcome was circuit clotting; the primary efficacy outcome was solute clearance.

Results: In vitro, all tandem methods were significantly faster (26.05-34.89 min vs. 55.40 min, p < 0.001) and consumed fewer resources while meeting all cleanliness standards. After preliminary safety screening excluded a faster flow rate (100 mL/min), the 50-mL/min slow-prime with 2,000-mL fast-flush protocol was selected. In the clinical trial, the incidence of grade I cartridge clotting was low and statistically comparable between the tandem (3.45%) and traditional (4.17%) groups (p > 0.05). Solute reduction values for urea, creatinine, and β₂-microglobulin were not significantly different, demonstrating comparable therapeutic efficacy.

Conclusion: The novel tandem priming protocol is a highly efficient, resource-sparing, and safe alternative to traditional methods. It maintains therapeutic efficacy and circuit patency, offering a valuable, standardized solution for clinical practice.