Efficacy of the CTR-001 direct hemoperfusion adsorption column in sepsis

Introduction

Despite developing therapeutic strategies, mortality of sepsis and septic shock has actually remained at a level of about 35–50%. The objective was to study the safety and effectiveness of a newly developed cytokine adsorption column in patients with sepsis and septic shock.

Methods

This study was a prospective, randomized, controlled clinical trial. The newly developed column contains microporous cellulose beads with a hexadecyl alkyl chain as the ligand. Eighteen patients with early septic shock or septic organ dysfunction were enrolled. Nine of 18 patients were randomized to direct hemoperfusion (DHP). All patients received supportive intensive care, and those randomized to DHP received direct hemoperfusion for 4 hours more than two times up to 14 times during 14 days.

Results

The decrease of the APACHE II score from the pretreatment level at the seventh day was significantly larger in the treatment group than in the control group (P = 0.0189; Mann–Whitney test). Adsorption-column-related serious adverse events were not observed in the DHP group. The concentration of IL-6 and IL-8 in the plasma decreased from the pretreatment level in the DHP group significantly (P = 0.0464 and P = 0.0464, respectively; Wilcoxon test).

Conclusion

The newly developed DHP column improved the septic shock better than the ordinary supportive intensive care.