Abstract

Hemoadsorption (HA) is used as an adjunctive therapy in life-threatening sepsis to reduce endotoxin and inflammatory mediators. Eferon LPS NEO is a pediatric version of the Eferon LPS cartridge, featuring a porous polymeric adsorbent with a surface-immobilized LPS-selective ligand, specifically designed for use in children.

This multicenter controlled study (NCT05707494) evaluated the feasibility and clinically relevant effects of hemoadsorption with Eferon LPS NEO in pediatric patients with sepsis.

A total of 78 children aged 1 to 204 months were enrolled. Thirty-two patients received hemoadsorption using the Eferon LPS NEO cartridge (hemoadsorption group, HAG), while 46 patients received standard of care alone (control group, CG). Patients in the HAG underwent two hemoadsorption sessions with a cumulative treatment duration of 18 hours. The primary endpoint was the effect of hemoadsorption on the pediatric Sequential Organ Failure Assessment (pSOFA) score.

At baseline (day 0), there were no significant differences between the HAG and CG in disease severity or key clinical parameters, including pSOFA score (10.1 vs 9.6), vasopressor use, vasopressor-inotropic score, oxygenation index (PaO₂/FiO₂), PRISM scores, incidence of acute kidney injury, use of invasive mechanical ventilation, or coagulation parameters.

The primary endpoint was achieved. On day 7, the mean pSOFA score was significantly lower in the hemoadsorption group compared with the control group (4.9 vs 7.8; p = 0.006), indicating reduced severity of multiple organ failure. Patients treated with Eferon LPS NEO were weaned significantly faster from invasive mechanical ventilation and vasopressor support (p = 0.003 and p = 0.001, respectively): 50% of patients were liberated from mechanical ventilation by day 6 versus day 37 in the control group, and from vasopressors by day 3 versus day 9.

In patients with septic shock, hemoadsorption was associated with a marked reduction in vasopressor requirements by day 3, reflected by a significantly lower median vasopressor-inotropic score (0.6 vs 10; p = 0.004). Oxygenation also improved, with a higher mean PaO₂/FiO₂ ratio in the hemoadsorption group on day 3 (314 vs 238 mmHg; p = 0.012).

Laboratory analyses demonstrated a rapid and significant reduction in inflammatory markers in the hemoadsorption group. By day 2, C-reactive protein levels decreased from 189 to 130 mg/L (p = 0.003), interleukin-6 from 700 to 42 pg/mL (p < 0.001), and tumor necrosis factor-α from 19 to 6.0 pg/mL (p < 0.001).

The 28-day mortality rate was significantly lower in patients treated with Eferon LPS NEO compared with the control group (9% vs 35%; OR = 0.2 [95% CI 0.05–0.74], p = 0.008).

These results indicate that hemoadsorption with Eferon LPS NEO reduced the severity of multiple organ failure and was associated with improved survival in pediatric patients with sepsis. The findings support further investigation of hemoadsorption in adequately powered randomized controlled trials.

Clinical outcomes in pediatric sepsis patients treated with Efferon LPS NEO (red) versus standard care (blue), including recovery from mechanical ventilation and shock, ICU mortality, and changes in key clinical parameters over the first 7 days (pSOFA score, PaO₂/FiO₂ ratio, and vasoactive-inotropic score).