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

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). 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.

• Authors: Jean-Louis Vincent, Pierre-François Laterre, Jonathan Cohen, Hilmar Burchardi, Hajo Bruining, Francisco Alvarez Lerma, Xavier Wittebole, Daniel De Backer, Stephen Brett, Dolores Marzo, Haruji Nakamura, Stephanie John
• Journal: Shock (Augusta, Ga.) (Shock) Vol. 23 Issue 5 Pg. 400-5 (May 2005) ISSN: 1073-2322 [Print] United States
• PMID: 15834304 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Endotoxins
• Interleukin-6
• Polymyxin B

Topics

• Adult
• Aged
• Anti-Bacterial Agents (chemistry, pharmacology)
• Endotoxins (metabolism)
• Female
• Hemoperfusion (instrumentation)
• Humans
• Interleukin-6 (metabolism)
• Kidney (metabolism)
• Male
• Middle Aged
• Myocardium (pathology)
• Perfusion
• Pilot Projects
• Polymyxin B (chemistry, pharmacology)
• Sepsis (therapy)
• Shock, Septic (therapy)
• Time Factors
• Treatment Outcome