References
Fisher CJ, Cook DJ. Critical evaluation of the design and conduct of previous clinical trials in sepsis. In: Update in Intensive Care and Emergency Medicine. Sibbald WJ, Vincent JL, eds. Berlin: Springer Verlag, 1995:317–328.
Bone RC. The systemic inflammatory response syndrome (SIRS). In: Update in Intensive Care and Emergency Medicine. Sibbald WJ, Vincent JL, eds. Berlin: Springer Verlag, 1995:3–12.
Guyatt GH, Sackett DL, Cook DJ, et al. Users' guides to the medical literature II. How to use an article about therapy or prevention A. Are the results of the study valid? JAMA 1993;270:2598–2601.
Ziegler EJ, McCutchan JA, Fierer J, et al. Treatment of Gram-negative bacteremia and shock with human antiserum to a mutant Escherichia coli. N Engl J Med 1982; 307:1225–1230.
Lindquist L, Lundbergh P, Maasing R. Pepsin-treated human gamma globulin in bacterial infections. A randomized study in patients with septicaemia and pneumonia. Vox Sang 1981;40:329–337.
Grundman R, Hornung M. Immunoglobulin therapy in patients with endotoxemia and postoperative sepsis—a prospective randomized study. In: Bacterial Endotoxins: Pathophysiological Effects, Clinical Significance, and Pharmacological Control, Alan R. Liss, Inc. 1988:339–349.
Schedel I, Dreikhausen U, Nentwig B, et al. Treatment of Gram-negative septic shock with an immunoglobulin preparation: A prospective, randomized clinical trial. Crit Care Med 1991;19:1104–1113.
Calandra T, Glauser MP, Schellekens J, et al. Treatment of Gram-negative shock with human IgG antibody to Escherichia coli J5: A prospective, double-blind, randomized trial. J Infect Dis 1988;158:312–318.
Aitchison JM, Arbuckle DD. Anti-endotoxin in the treatment of severe surgical septic shock. S Afr Med J 1985;68: 787–789.
Kett DH, Quartin AA, Sprung CL, et al. An evaluation of the hemodynamic effects of HA-1A human monoclonal antibody. Crit Care Med 1994;22:1227–1234.
Greenman RL, Schein RMH, Martin MA, et al. A controlled clinical trial of E5 murine monoclonal IgM antibody to endotoxin in the treatment of Gram-negative sepsis. JAMA 1991;266:1097–1102.
Greenberg RN, Wilson KM, Kunz AY, et al. Observations using antiendotoxin antibody (E5) as adjuvant therapy in humans with suspected, serious, Gram-negative sepsis. Crit Care Med 1992;20:730–735.
Bone RC, Balk RA, Fein AM, et al. A second large controlled clinical study of E5, a monoclonal antibody to endotoxin: results of a prospective, multicenter, randomized, controlled trial. Crit Care Med 1995;23:994–1006.
Ziegler EJ, Fisher CJ, Sprung CL, et al. Treatment of Gramnegative bacteremia and septic shock with HA-1A human monoclonal antobody against endotoxin. N Engl J Med 1991; 324:429–436.
Wortel CH, von der Mohlen MAM, van Deventer SJH, et al. Effectiveness of a human monoclonal anti-endotoxin antibody (HA-1A) in Gram-negative sepsis: relationship to endotoxin and cytokine levels. J Infect Dis 1992;166:1367–1374.
McCloskey RV, Straube RC, Sanders C, et al. Treatment of septic shock with human monoclonal antobody HA-1A. Ann Intern Med 1994;121:1–5.
Willatts SM, Radford S, Leitermann M. Effect of the antiendotoxic agent, taurolidine, in the treatment of sepsis syndrome: a placebo-controlled, double-blind trial. Crit Care Med 1995;23:1033–1039.
Dhainaut J-F A, Tenaillon A, Le Tulzo Y, et al. Platelet-activating factor receptor antagonist BN 52021 in the treatment of severe sepsis: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Crit Care Med 1994;22: 1720–1728.
Fisher CJ, Slotman GJ, Opal SM, et al. Initial evaluation of human recombinant interleukin-1 receptor antagonist in the treatment of sepsis syndrome: a randomized, open-lable, placebo-controlled multicenter trial. Crit Care Med 1994;22: 12–21.
Fisher CJ, Dhainaut J-FA, Opal SM, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. JAMA 1994;271: 1836–1843.
Boermeester MA, van Leeuwen PAM, Coyle SM, et al. Interleukin-1 blockade attenuates mediator release and dysregulation of the hemostatic mechanism during human sepsis. Arch Surg 1995;130:739–748.
Dhainaut J-FA, Vincent JL, Richard C, et al. CDP571, a human antibody to human tumor necrosis factor-a: safety, pharmacokinetics, immune response, and influence of the antibody on cytokine concentrations in patients with septic shock. Crit Care Med 1995;23:1461–1469.
Cohen J, Carlet J, for the INTERSEPT Study Group. INTERSEPT: an international, multicenter, palcebo-controlled trial of monoclonal antibody to human tumor necrosis factora in patients with sepsis. Crit Care Med 1996;24:1431–1440.
Abraham E, Wunderink R, Silverman H, et al. Efficacy and safety of monoclonal antibody to human tumor necrosis factor-a in patients with sepsis syndrome. JAMA 1995;273: 934–941.
Reinhart K, Wiegand-Lohnert C, Grimminger F, et al. Assessment of the safety and efficacy of the monoclonal antitumor necrosis factor antibody-fragment, MAK 195F, in patients with sepsis and septic shock: a multicenter, randomized, placebo-controlled, dose-ranging study. Crit Care Med 1996;24:733–742.
Fisher CJ, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor:Fc fusion protein. N Engl J Med 1996;334:1697–1702.
Zeni F, Pain P, Vindimian M, et al. Effects of pentoxifylline on circulating cytokine concentrations and hemodynamics in patients with septic shock: results from a double-blind, randomized, placebo-controlled study. Crit Care Med 1996;24: 207–214.
Sprung CL, Caralis PV, Marcial EH, et al. The effects of high-dose corticosteroids in patients with septic shock. A prospective, controlled study. N Engl J Med 1984;311: 1137–1143.
The Veterans Administration Systemic Sepsis Cooperative Study Group. Effect of high-dose glucocorticid therapy on mortality in patients with clinical signs of systemic sepsis. N Engl J Med 1987;317:659–665.
Bone RC, Fisher CJ, Clemmer TP, Slotman GJ, Metz CA, Balk RA, and the Methylprednisolone Severe Sepsis Study Group. A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. N Engl J Med 1987;317:653–658.
Bone RC, Fisher CJ, Clemmer TP, et al. Early methylprednisolone treatment for septic syndrome and the adult respiratory distress syndrome. Chest 1987;92:1032–1036.
Slotman GJ, Fisher CJ, Bone RG, et al. Detrimental effects of high-dose methylprednisolone sodium succinate on serum concentrations of hepatic and renal function indicators insevere sepsis and septic shock. Crit Care Med 1993;21: 191–195.
Luce JM, Montgomery AB, Marks JD, et al. Ineffectiveness of high-dose methylprednisolone in preventing parenchymal lung injury and improving mortlaity in patients with septic shock. Am Rev Respir Dis 1988;138:62–68.
Marks JD, Marks CB, Luce JM, et al. Plasma tumor necrosis factor in patients with septic shock. Mortality rate, incidence of adult respiratory distress syndrome, and effects of methylprednisolone administration. Am Rev Respir Dis 1990;141:94–97.
Haupt MT, Jastremski MS, clemmer TP, et al. Effect of ibuprofen in patients with severe sepsis: a randomized, double-blind, multicenter study. Crit Care Med 1991;19: 1339–1347.
Bernard GR, Reines HD, Halushka PV, et al. Prostacyclin and thromboxane A2 formation is increased in human sepsis syndrome. Effects of cyclooxygenase inhibition. Am Rev Respir Dis 1991;144:1095–1101.
Guyatt GH, Meade MO. Outcome measures: methodologic principles. Sepsis 1997;1:pp.
Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990;263:1385–1389.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Meade, M.O., Creery, D. & Marshall, J.C. Systematic Review of Outcome Measures in Randomized Trials of Mediator-Directed Therapies in Sepsis. Sepsis 1, 27–33 (1997). https://doi.org/10.1023/A:1009707200575
Issue Date:
DOI: https://doi.org/10.1023/A:1009707200575