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Once is not enough: clinical trials in sepsisOpen access

Daniel A. Sweeney| Robert L. Danner| Peter Q. Eichacker| Charles Natanson
Editorial
Volume 34, Issue 11 / November , 2008

Pages 1955 - 1960

No abstract available.

References

  1. Finfer S, Ranieri M, Thompson BT, Barie PS, Dhainaut J-F, Douglas IS, Gårdlund B (2008) Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Intensive Care Med. doi:10.1007/s00134-008-1266-6
  2. Bertolini G, Rossi C, Anghileri A, Livigni S, Addis A, Poole D (2007) Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey. Intensive Care Med 33:426–434
  3. Kanji S, Perreault MM, Chant C, Williamson D, Burry L (2007) Evaluating the use of Drotrecogin alfa (activated) in adult severe sepsis: a Canadian multicenter observational study. Intensive Care Med 33:517–523
  4. Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B (2007) REsearching severe sepsis, organ dysfunction in children: a global perspective (RESOLVE) study group Drotrecogin alfa (activated) in children with severe sepsis: multicentre phase III randomised controlled trial. Lancet 369:836–843
    • View reference on PubMed
    • View reference on publisher's website
  5. Rowan KM, Welch CA, North E, Harrison DA (2008) Drotrecogin alfa (activated): real-life use and outcomes for the UK. Crit Care 12:R58
    • View reference on PubMed
    • View reference on publisher's website
  6. The Veterans Administration Systemic Sepsis Cooperative Study Group (1987) Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systemic sepsis. N Engl J Med 317:659–665
  7. The Intravenous Immunoglobulin Collaborative Study Group (1992) Prophylactic intravenous administration of standard immune globulin as compared with core-lipopolysaccharide immune globulin in patients at high risk of postsurgical infection. N Engl J Med 327:234–240
  8. J5 Study Group (1992) Treatment of severe infectious purpura in children with human plasma from donors immunized with Escherichia coli J5: a prospective double-blind study. J Infect Dis 165:695–701
  9. Abraham E, Laterre PF, Garg R, Levy H, Talwar D, Trzaskoma BL, François B, Guy JS, Brückmann M, Rea-Neto A, Rossaint R, Perrotin D, Sablotzki A, Arkins N, Utterback BG, Macias WL (2005) Administration of Drotrecogin Alfa (activated) in Early Stage Severe Sepsis (ADDRESS) Study Group Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 353:1332–1341
    • View reference on PubMed
    • View reference on publisher's website
  10. Baumgartner JD, Glauser MP, McCutchan JA, Ziegler EJ, van Melle G, Klauber MR, Vogt M, Muehlen E, Luethy R, Chiolero R et al (1985) Prevention of gram-negative shock and death in surgical patients by antibody to endotoxin core glycolipid. Lancet 2:59–63
    • View reference on PubMed
    • View reference on publisher's website
  11. Bennett ILFM, Hamburger M, Kass EH, Lepper M, Waisbren BA (1963) The effectiveness of hydrocortisone in the management of severe infection. JAMA 183:462–465
  12. Bernard GR, Ely EW, Wright TJ, Fraiz J, Stasek JE Jr, Russell JA, Mayers I, Rosenfeld BA, Morris PE, Yan SB, Helterbrand JD (2001) Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit Care Med 29:2051–2059
    • View reference on PubMed
    • View reference on publisher's website
  13. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr (2001) Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344:699–709
    • View reference on PubMed
    • View reference on publisher's website
  14. Bone RC, Balk RA, Fein AM, Perl TM, Wenzel RP, Reines HD, Quenzer RW, Iberti TJ, Macintyre N, Schein RM (1995) A second large controlled clinical study of E5, a monoclonal antibody to endotoxin: results of a prospective, multicenter, randomized, controlled trial. The E5 Sepsis Study Group. Crit Care Med 23:994–1006
    • View reference on PubMed
    • View reference on publisher's website
  15. Bone RC, Fisher CJ Jr, Clemmer TP, Slotman GJ, Metz CA, Balk RA (1987) A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. N Engl J Med 317:653–658
    • View reference on PubMed
  16. Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K (2008) German Competence Network Sepsis (SepNet) Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 358:125–139
    • View reference on PubMed
    • View reference on publisher's website
  17. Calandra T, Glauser MP, Schellekens J, Verhoef J (1988) Treatment of gram-negative septic shock with human IgG antibody to Escherichia coli J5: a prospective, double-blind, randomized trial. J Infect Dis 158:312–319
    • View reference on PubMed
  18. Fisher CJ Jr, Dhainaut JF, Opal SM, Pribble JP, Balk RA, Slotman GJ, Iberti TJ, Rackow EC, Shapiro MJ, Greenman RL et al (1997) Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. Phase III rhIL-1ra Sepsis Syndrome Study Group. JAMA 271:1836–1843
    • View reference on publisher's website
  19. Fisher CJ Jr, Slotman GJ, Opal SM, Pribble JP, Bone RC, Emmanuel G, Ng D, Bloedow DC, Catalano MA (1994) IL-1RA Sepsis Syndrome Study Group Initial evaluation of human recombinant interleukin-1 receptor antagonist in the treatment of sepsis syndrome: a randomized, open-label, placebo-controlled multicenter trial. Crit Care Med 22:12–21
    • View reference on PubMed
    • View reference on publisher's website
  20. Greenman RL, Schein RM, Martin MA, Wenzel RP, MacIntyre NR, Emmanuel G, Chmel H, Kohler RB, McCarthy M, Plouffe J et al (1991) A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of gram-negative sepsis. The XOMA Sepsis Study Group. JAMA 266:1097–1102
    • View reference on PubMed
    • View reference on publisher's website
  21. Klastersky J, Cappel R, Debusscher L (1971) Effectiveness of betamethasone in management of severe infections. A double-blind study. N Engl J Med 284:1248–1250
    • View reference on PubMed
  22. Lucas CE, Ledgerwood AM (1984) The cardiopulmonary response to massive doses of steroids in patients with septic shock. Arch Surg 119:537–541
    • View reference on PubMed
  23. Luce JM, Montgomery AB, Marks JD, Turner J, Metz CA, Murray JF (1988) Ineffectiveness of high-dose methylprednisolone in preventing parenchymal lung injury and improving mortality in patients with septic shock. Am Rev Respir Dis 138:62–68
    • View reference on PubMed
  24. 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
  25. McCutchan JA, Wolf JL, Ziegler EJ, Braude AI (1983) Ineffectiveness of single-dose human antiserum to core glycolipid (E. coli J5) for prophylaxis of bacteremic, gram-negative infections in patients with prolonged neutropenia. Schweiz Med Wochenschr Suppl 14:40–45
    • View reference on PubMed
  26. Opal SM, Fisher CJ Jr, Dhainaut JF, Vincent JL, Brase R, Lowry SF, Sadoff JC, Slotman GJ, Levy H, Balk RA, Shelly MP, Pribble JP, LaBrecque JF, Lookabaugh J, Donovan H, Dubin H, Baughman R, Norman J, DeMaria E, Matzel K, Abraham E, Seneff M (1997) Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group. Crit Care Med 25:1115–1124
    • View reference on PubMed
    • View reference on publisher's website
  27. Schumer W (1976) Steroids in the treatment of clinical septic shock. Ann Surg 184:333–341
    • View reference on PubMed
    • View reference on publisher's website
  28. Sprung CL, Caralis PV, Marcial EH, Pierce M, Gelbard MA, Long WM, Duncan RC, Tendler MD, Karpf M (1984) The effects of high-dose corticosteroids in patients with septic shock. A prospective, controlled study. N Engl J Med 311:1137–1143
    • View reference on PubMed
  29. Thompson WL, Gurley HT, Lutz BA, Jackson DL, Kyols LK, Morris IA (1976) Inefficacy of glucocorticoids in shock (double-blind study) (Abstract). Clin Res 24:258A
  30. Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R (2006) Intensive insulin therapy in the medical ICU. N Engl J Med 354:449–461
    • View reference on PubMed
    • View reference on publisher's website
  31. Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R (2001) Intensive insulin therapy in the critically ill patients. N Engl J Med 345:1359–1367
    • View reference on PubMed
    • View reference on publisher's website
  32. Ziegler EJ, Fisher CJ Jr, Sprung CL, Straube RC, Sadoff JC, Foulke GE, Wortel CH, Fink MP, Dellinger RP, Teng NN et al (1991) Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin. A randomized, double-blind, placebo-controlled trial. The HA-1A Sepsis Study Group. N Engl J Med 324:429–436
    • View reference on PubMed
  33. Ziegler EJ, McCutchan JA, Fierer J, Glauser MP, Sadoff JC, Douglas H, Braude AI (1982) Treatment of gram-negative bacteremia and shock with human antiserum to a mutant Escherichia coli. N Engl J Med 307:1225–1230
    • View reference on PubMed
  34. Alejandra MM, Lansang MA, Dans, LF, Mantaring JBV (2002) Intravenous immunoglobulin for treating sepsis and septic shock. Cochrane Database of Systematic Reviews, Issue 1. Art. No.: CD001090. DOI: 10.1002/14651858.CD001090
  35. Pildal J, Gøtzsche PC (2004) Polyclonal immunoglobulin for treatment of bacterial sepsis: A systemic review. Clin Infect Dis 39:38–46
    • View reference on PubMed
    • View reference on publisher's website
  36. Turgeon AF, Hutton B, Fergusson DA, McIntyre L, Tinmouth AA, Cameron DW, Hébert PC (2007) Meta-analysis: intravenous immunoglobulin in critically ill adult patients with sepsis. Ann Intern Med 146:193–203
    • View reference on PubMed
  37. Laupland KB, Kirkpatrick AW, Delaney A (2007) Polyclonal intravenous immunoglobulin for the treatment of severe sepsis and septic shock in critically ill adults: a systematic review and meta-analysis. Crit Car Med 35:2686–2692
  38. Parker MM, Shelhamer JH, Bacharach SL, Green MV, Natanson C, Frederick TM, Damske BA, Parrillo JE (1984) Profound but reversible myocardial depression in patients with septic shock. Ann Intern Med 100:483–490
    • View reference on PubMed
  39. Minneci PC, Deans KJ, Banks SM, Eichacker PQ, Natanson C (2004) Meta-analysis: the effect of steroids on survival and shock during sepsis depends on the dose. Ann Intern Med 141:47–56
    • View reference on PubMed
  40. Wolff SM (1982) The treatment of gram-negative bacteremia and shock. N Engl J Med 307:1267–1268
    • View reference on PubMed
  41. Natanson C, Hoffman WD, Suffredini AF, Eichacker PQ, Danner RL (1994) Selected treatment strategies for septic shock based on proposed mechanisms of pathogenesis. Ann Intern Med 120:771–783
    • View reference on PubMed
  42. Warren HS, Danner RL, Munford RS (1992) Anti-endotoxin monoclonal antibodies. N Engl J Med 326:1153–1157
    • View reference on PubMed
  43. Quezado ZM, Natanson C, Alling DW, Banks SM, Koev CA, Elin RJ, Hosseini JM, Bacher JD, Danner RL, Hoffman WD (1993) A controlled trial of HA-1A in a canine model of gram-negative septic shock. JAMA 269:2221–2227
    • View reference on PubMed
    • View reference on publisher's website
  44. Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM (2004) Surviving sepsis campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med 30:536–555
  45. Anon (2001) Package Insert for Drotrecogin alfa (activated). In: Eli Lilly and Company
  46. Eichacker PQ, Natanson C (2007) Increasing evidence that the risks of rhAPC may outweigh its benefits. Intensive Care Med 33:396–399
  47. Gardlund B (2006) Activated protein C (Xigris) treatment in sepsis: a drug in trouble. Acta Anaesthesiol Scand 50:907–910
    • View reference on PubMed
    • View reference on publisher's website
  48. Food and Drug Administration Modernization Act of 1997 (Sect. 115a). Pub. L. No. 105–115, Sect. 115, 111 Stat. 2295, 2313
  49. Soylemez Wiener R, Wiener DC, Larson RJ (2008) Benefits and risks of tight glucose control in critically ill adults: a meta-analysis. JAMA 300:933–944
    • View reference on publisher's website
  50. Tobin MJ (2008) Counterpoint: evidence-based medicine lacks a sound scientific base. Chest 133:1071–1074
    • View reference on PubMed
    • View reference on publisher's website

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