A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection.
Endotoxin is an important pathogenic trigger for sepsis. The polymyxin B-immobilized endotoxin removal hemoperfusion cartridge, Toraymyxin (hereafter PMX), has been shown to remove endotoxin in preclinical and open-label clinical studies. In a multicenter, open-label, pilot, randomized, controlled study conducted in the intensive care unit in six academic medical centers in Europe, 36 postsurgical patients with severe sepsis or septic shock secondary to intra-abdominal infection were randomized to PMX treatment of 2 h (n = 17) or standard therapy (n = 19). PMX was well tolerated and showed no significant side effects. There were no statistically significant differences in the change in endotoxin levels from baseline to 6 to 8 h after treatment or to 24 h after treatment between the two groups. There was also no significant difference in the change in interleukin (IL)-6 levels from baseline to 6 to 8 h after treatment or to 24 h after treatment between the two groups. Patients treated with PMX demonstrated significant increases in cardiac index (CI; P = 0.012 and 0.032 at days 1 and 2, respectively), left ventricular stroke work index (LVSWI, P = 0.015 at day 2), and oxygen delivery index (DO2I, P = 0.007 at day 2) compared with the controls. The need for continuous renal replacement therapy (CRRT) after study entry was reduced in the PMX group (P = 0.043). There was no significant difference between the groups in organ dysfunction as assessed by the Sequential Organ Failure Assessment (SOFA) scores from day 0 (baseline) to day 6. Treatment using the PMX cartridge is safe and may improve cardiac and renal dysfunction due to sepsis or septic shock. Further studies are needed to prove this effectiveness.
Vincent
Jean-Louis
JL
Department of Intensive Care, Erasme Hospital, Free University of Brussels, Brussels, Belgium. jlvincen@ulb.ac.be
Laterre
Pierre-François
PF
Cohen
Jonathan
J
Burchardi
Hilmar
H
Bruining
Hajo
H
Lerma
Francisco Alvarez
FA
Wittebole
Xavier
X
De Backer
Daniel
D
Brett
Stephen
S
Marzo
Dolores
D
Nakamura
Haruji
H
John
Stephanie
S
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000737:chemistry / Q000494:pharmacology*; D004731:Endotoxins / Q000378:metabolism; D005260:Female; D006464:Hemoperfusion / Q000295:instrumentation*; D006801:Humans; D015850:Interleukin-6 / Q000378:metabolism; D007668:Kidney / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology; D010477:Perfusion; D010865:Pilot Projects; D011112:Polymyxin B / Q000737:chemistry / Q000494:pharmacology*; D018805:Sepsis / Q000628:therapy*; D012772:Shock, Septic / Q000628:therapy; D013997:Time Factors; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004731:Endotoxins; D015850:Interleukin-6; D011112:Polymyxin B