Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial

Abstract

PurposeTo test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections.MethodProspective, multicenter, randomized controlled trial in 18 French intensive care units from October 2010 to March 2013, enrolling 243 patients with SS within 12 h after emergency surgery for peritonitis related to organ perforation. The PMX HP group received conventional therapy plus two sessions of PMX HP. Primary outcome was mortality on day 28; secondary outcomes were mortality on day 90 and a reduction in the severity of organ failures based on Sequential Organ Failure Assessment (SOFA) scores.ResultsPrimary outcome: day 28 mortality in the PMX HP group (n = 119) was 27.7 versus 19.5 % in the conventional group (n = 113), p = 0.14 (OR 1.5872, 95 % CI 0.8583–2.935). Secondary endpoints: mortality rate at day 90 was 33.6 % in PMX-HP versus 24 % in conventional groups, p = 0.10 (OR 1.6128, 95 % CI 0.9067–2.8685); reduction in SOFA score from day 0 to day 7 was −5 (−11 to 6) in PMX-HP versus −5 (−11 to 9), p = 0.78. Comparable results were observed in the predefined subgroups (presence of comorbidity; adequacy of surgery, <2 sessions of hemoperfusion) and for SOFA reduction from day 0 to day 3.ConclusionThis multicenter randomized controlled study demonstrated a non-significant increase in mortality and no improvement in organ failure with PMX HP treatment compared to conventional treatment of peritonitis-induced SS.Electronic supplementary materialThe online version of this article (doi:10.1007/s00134-015-3751-z) contains supplementary material, which is available to authorized users.

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG2016)

“…Moreover, these RCTs did not assess shock recovery rate, and also did not recognize thrombocytopenia as an adverse event. Meanwhile, Payen et al 275. reported a significant decrease in the incidence of thrombocytopenia occurring on day 3 of treatment in the PMX‐DHP group, but did not quantify the reductions in platelet count.…”

“…However, as several new RCTs274, 275, 481 to investigate the utility of blood apheresis in the treatment of sepsis in adult patients have been announced successively in Europe and the United States, assessing the significance of this intervention for pediatric patients is believed to be valuable.…”

History and current status of polymyxin B‐immobilized fiber column for treatment of severe sepsis and septic shock

“…The results of a subsequent RCT in Europe, the EUPHAS study (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis), which was conducted in Italy, were published in 2009, showing that PMX results in a significant reduction in sepsis‐associated mortality 7. A large RCT, the ABDO‐MIX trial (Effects of Hemoperfusion with a Polymyxin B Membrane in Peritonitis with Septic Shock) in France, failed to show a survival benefit and improvement in organ failure with PMX compared to the conventional treatment of peritonitis‐induced septic shock 8. Another large RCT, the EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in an RCT of Adults Treated for Endotoxemia and Septic Shock) in the USA and Canada,9 is closed to new patients and analysis is ongoing.…”

“…The ABDO‐MIX trial was conducted in France 8. A total of 243 patients with peritonitis‐induced septic shock from abdominal infections were enrolled, and the primary endpoint of the study was the 28‐day mortality.…”

Balancing the “humors” in severe sepsis: still a role for extracorporeal therapies?

“…In a recent article in Intensive Care Medicine, the ABDOMIX group reports their findings from the largest randomised controlled study on PMX hemoperfusion in sepsis completed to date [14]. In this trial, patients with documented peritonitis and septic shock were allocated to receive either two sessions of PMX hemoperfusion or usual care following surgery.…”