A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection

Vincent, Jean-Louis;Laterre, Pierre-François;Cohen, Jonathan;Burchardi, Hilmar;John, Stephanie;et.al.
(2005) Shock (Philadelphia) : injury, inflammation, and sepsis: laboratory and clinical approaches — Vol. 23, n° 5, p. 400-405 (2005)

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Authors
  • Vincent, Jean-Louis
    Author
  • Laterre, Pierre-FrançoisUCLouvain
    Author
  • Cohen, Jonathan
    Author
  • Burchardi, Hilmar
    Author
  • Wittebole, XavierUCLouvain
    Author
  • John, Stephanie
    Author
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Abstract
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). PIVIX 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 PIVIX 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 PIVIX cartridge is safe and may improve cardiac and renal dysfunction due to sepsis or septic shock. Further studies are needed to prove this effectiveness.
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Vincent, J.-L., Laterre, P.-F., Cohen, J., Burchardi, H., Bruining, H., Lerma, F. A., Wittebole, X., De Backer, D., Brett, S., Marzo, D., Nakamura, H., & John, S. (2005). A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection. Shock (Philadelphia) : injury, inflammation, and sepsis: laboratory and clinical approaches, 23(5), 400-405. https://doi.org/10.1097/01.shk.0000159930.87737.8a (Original work published 2005)