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

Didier M. Payen| Joelle Guilhot| Yoann Launey| Anne Claire Lukaszewicz| Mahmoud Kaaki| Benoit Veber| Julien Pottecher| Olivier Joannes-Boyau| Laurent Martin-Lefevre| Matthieu Jabaudon| Olivier Mimoz| Rémi Coudroy| Martine Ferrandière| Eric Kipnis| Carlos Vela| Stéphanie Chevallier| Jihad Mallat| René Robert
Seven-Day Profile Publication
Volume 41, Issue 6 / June , 2015

Pages 975 - 984

Abstract

Purpose

To test whether the polymyxin B hemoperfusion (PMX HP) fiber column reduces mortality and organ failure in peritonitis-induced septic shock (SS) from abdominal infections.

Method

Prospective, 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.

Results

Primary 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.

Conclusion

This 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.

Keywords

References

  1. Liu V, Escobar GJ, Greene JD, Soule J, Whippy A, Angus DC, Iwashyna TJ (2014) Hospital deaths in patients with sepsis from 2 independent cohorts. JAMA 312:90–92
    • View reference on PubMed
    • View reference on publisher's website
  2. Koperna T, Schulz F (1996) Prognosis and treatment of peritonitis. Do we need new scoring systems? Arch Surg 131:180–186
    • View reference on PubMed
    • View reference on publisher's website
  3. Riche FC, Dray X, Laisne MJ, Mateo J, Raskine L, Sanson-Le Pors MJ, Payen D, Valleur P, Cholley BP (2009) Factors associated with septic shock and mortality in generalized peritonitis: comparison between community-acquired and postoperative peritonitis. Crit Care 13:R99
    • View reference on PubMed
    • View reference on publisher's website
  4. Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen M, Lynn M, Rossignol DP, Gogate J, Roberts MB, Wheeler JL, Vincent JL (2013) Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial. JAMA 309:1154–1162
    • View reference on PubMed
    • View reference on publisher's website
  5. Losser MR, Bernard C, Beaudeux JL, Pison C, Payen D (1997) Glucose modulates hemodynamic, metabolic, and inflammatory responses to lipopolysaccharide in rabbits. J Appl Physiol 83:1566–1574
    • View reference on PubMed
  6. Calvano SE, Xiao W, Richards DR, Felciano RM, Baker HV, Cho RJ, Chen RO, Brownstein BH, Cobb JP, Tschoeke SK, Miller-Graziano C, Moldawer LL, Mindrinos MN, Davis RW, Tompkins RG, Lowry SF (2005) A network-based analysis of systemic inflammation in humans. Nature 437:1032–1037
    • View reference on PubMed
    • View reference on publisher's website
  7. McCloskey RV, Straube RC, Sanders C, Smith SM, Smith CR (1994) Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group. Ann Intern Med 121:1–5
    • View reference on PubMed
    • View reference on publisher's website
  8. Joannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A (2013) High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med 39:1535–1546
  9. Payen D, Mateo J, Cavaillon JM, Fraisse F, Floriot C, Vicaut E, Hemofiltration, Sepsis Group of the College National de Reanimation et de Medecine d’Urgence des Hopitaux e-U (2009) Impact of continuous venovenous hemofiltration on organ failure during the early phase of severe sepsis: a randomized controlled trial. Crit Care Med 37:803–810
    • View reference on PubMed
    • View reference on publisher's website
  10. Vincent JL, Laterre PF, Cohen J, Burchardi H, Bruining H, Lerma FA, 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 23:400–405
    • View reference on PubMed
    • View reference on publisher's website
  11. Nakamura T, Ebihara I, Shoji H, Ushiyama C, Suzuki S, Koide H (1999) Treatment with polymyxin B-immobilized fiber reduces platelet activation in septic shock patients: decrease in plasma levels of soluble P-selectin, platelet factor 4 and beta-thromboglobulin. Inflamm Res 48:171–175
    • View reference on PubMed
    • View reference on publisher's website
  12. Nakamura T, Kawagoe Y, Suzuki T, Shoji H, Ueda Y, Koide H (2007) Polymyxin B-immobilized fiber hemoperfusion with the PMX-05R column in elderly patients suffering from septic shock. Am J Med Sci 334:244–247
    • View reference on PubMed
    • View reference on publisher's website
  13. Nemoto H, Nakamoto H, Okada H, Sugahara S, Moriwaki K, Arai M, Kanno Y, Suzuki H (2001) Newly developed immobilized polymyxin B fibers improve the survival of patients with sepsis. Blood Purif 19:361–368 (discussion 368–369)
    • View reference on PubMed
    • View reference on publisher's website
  14. Shoji H (2003) Extracorporeal endotoxin removal for the treatment of sepsis: endotoxin adsorption cartridge (Toraymyxin). Ther Apher Dial 7:108–114
    • View reference on PubMed
    • View reference on publisher's website
  15. Suzuki H, Nemoto H, Nakamoto H, Okada H, Sugahara S, Kanno Y, Moriwaki K (2002) Continuous hemodiafiltration with polymyxin-B immobilized fiber is effective in patients with sepsis syndrome and acute renal failure. Ther Apher 6:234–240
    • View reference on PubMed
    • View reference on publisher's website
  16. Cruz DN, Perazella MA, Bellomo R, de Cal M, Polanco N, Corradi V, Lentini P, Nalesso F, Ueno T, Ranieri VM, Ronco C (2007) Effectiveness of polymyxin B-immobilized fiber column in sepsis: a systematic review. Crit Care 11:R47
    • View reference on PubMed
    • View reference on publisher's website
  17. Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C (2009) Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA 301:2445–2452
    • View reference on PubMed
    • View reference on publisher's website
  18. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G, International Sepsis Definitions C (2003) 2001 SCCM/ESICM/ACCP/ATS/SIS international sepsis definitions conference. Intensive Care Med 29:530–538
  19. Scheller J, Garbers C, Rose-John S (2014) Interleukin-6: from basic biology to selective blockade of pro-inflammatory activities. Semin Immunol 26:2–12
    • View reference on PubMed
    • View reference on publisher's website
  20. Wacha H, Hau T, Dittmer R, Ohmann C (1999) Risk factors associated with intraabdominal infections: a prospective multicenter study. Peritonitis Study Group. Langenbecks Arch Surg 384:24–32
    • View reference on PubMed
    • View reference on publisher's website
  21. Iwagami M, Yasunaga H, Doi K, Horiguchi H, Fushimi K, Matsubara T, Yahagi N, Noiri E (2014) Postoperative polymyxin B hemoperfusion and mortality in patients with abdominal septic shock: a propensity-matched analysis. Crit Care Med 42:1187–1193
    • View reference on PubMed
    • View reference on publisher's website
  22. Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD, Group P-SS (2012) Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 366:2055–2064
    • View reference on PubMed
    • View reference on publisher's website

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