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A Phase I clinical trial was carried out to evaluate the effects of endotoxin elimination by direct hemoperfusion using a cartridge containing chemically immobilized polymyxin B fibers (PMX-F). Thirty-seven endotoxemic patients with multiple organ failure (MOF) were treated. Direct hemoperfusion for 2 h using a PMX-F column was performed (PMX). PMX could remove circulating endotoxin from severely endotoxemic patients. Plasma endotoxin level was significantly decreased between its inlet and outlet level of PMX-F column ( P < 0.01). The mean plasma endotoxin concentration of all PMX ( n = 51) was 83.7 ± 26.7 pg/ml before PMX, and significantly decreased to 56.4 ± 27.9 after ( P < 0.01). Plasma endotoxin was significantly decreased in survivors, but that of non-survivors did not change with PMX ( P < 0.05). Body temperature, blood pressure, cardiac index, systemic vascular resistance and the oxygen consumption index improved significantly after PMX. Inotropic and vasopressive drugs were discontinued or reduced with PMX. PMX treatment showed a correlation between reduction of plasma endotoxin level and the improvement of septic syndrome, especially cardiovascular impairments. Also, this new therapy seemed to influence the outcome of severe sepsis or septic MOF patients with endotoxemia.

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