Improving of APACHE II score at the early phase using CTR-001 direct hemoperfusion in patients with severe sepsis and septic shock

Introduction

We reported the clinical efficacy of a newly developed cytokine adsorption column (CTR-001; Kaneka Co., Osaka, Japan) for the septic patients at the previous meeting. Especially, increasing blood pressure was remarkable during use of CTR-001 in septic shock patients. In this study, we investigate that clinical efficacy concerning the improvement of APACHE II and SOFA scores.

Methods

A prospective randomized, controlled clinical trial was performed in this study. 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 the 18 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. We measured the plasma concentration of IL-6, IL-8, IL-1β, and TNFα. The APACHE II score and SOFA score were evaluated for each patient on the 1st, 7th, 14th and 28th day after starting treatment before the treatment in the morning.

Results

The decrease of APACHE II score from the pretreatment level at the 7th day was significantly larger in the CTR-001 treatment group than in the control group (P = 0.0189; Mann–Whitney test). On the other hand, there were no significant changes of the SOFA score at the 7th day. 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, P = 0.0464 respectively; Wilcoxon test).

Conclusion

The newly developed direct hemoperfusion column improved the septic shock better than the ordinary supportive intensive care. This new cytotoxic removal column may play an important role in treatment of patients with septic shock.