Dellinger RP, et al. - Among patients with septic shock and high endotoxin activity, researchers explored whether adding polymyxin B hemoperfusion to conventional medical therapy improves survival compared with conventional therapy alone. Results indicated that polymyxin B hemoperfusion treatment plus conventional medical therapy vs sham treatment plus conventional medical therapy did not decrease mortality at 28 days among patients with septic shock and high endotoxin activity. Worsening of sepsis and worsening of septic shock were the most frequent serious adverse events.

Methods

• This trial involved 450 adult critically ill patients with septic shock and an endotoxin activity assay level of ≥ 0.60 who were enrolled September 2010–June 2016 at 55 tertiary hospitals in North America.
• Last follow-up was June 2017.
• Main interventions analyzed were two polymyxin B hemoperfusion treatments (90-120 minutes) plus standard therapy completed within 24 hours of enrollment (n=224) or sham hemoperfusion plus standard therapy (n=226).
• Mortality at 28 days was the primary outcome among all patients randomized (all participants) and among patients randomized with a multiple organ dysfunction score (MODS) of > 9.

Results

• Findings showed that, among study participants (mean age, 59.8 years; 177 [39.3%] women; mean APACHE II score 29.4 [range, 0-71 with higher scores indicating greater severity]), 449 (99.8%) finished the examination.
• They did not observe any association of polymyxin B hemoperfusion with a significant difference in mortality at 28 days among participants (treatment group, 37.7% vs sham group, 34.5%; risk difference [RD], 3.2%; 95% CI, -5.7% to 12.0%; relative risk [RR], 1.09; 95% CI, 0.85-1.39; P=0.49) or in the population with a MODS > 9 (treatment group, 44.5% vs sham, 43.9%; RD, 0.6%; 95% CI, -10.8% to 11.9%; RR, 1.01; 95% CI, 0.78-1.31; P=0.92).
• A total of 264 serious adverse events were reported (65.1% in the treatment group vs 57.3% in the sham group).
• Worsening of sepsis (10.8% in the treatment group vs 9.1% in the sham group) and worsening of septic shock (6.6% in the treatment group vs 7.7% in the sham group) were the most frequent serious adverse events.