Introducing critical appraisal to studies of animal models investigating novel therapies in sepsis

Critical Care Medicine

Volumn 24, Issue 12, 1996, Pages 2059-2070

  Piper, Richard D ^a   Cook, Deborah J ^b   Bone, Roger C ^c   Sibbald, William J ^a,d  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

^c RUSH UNIVERSITY MEDICAL CENTER   (United States)

^d LONDON HEALTH SCIENCES CENTRE   (Canada)

Author keywords

animal models; clinical trials; critical appraisal; critical illness; cytokines; evidence based medicine; infection; lipopolysaccharide; sepsis; tumor necrosis factor

Indexed keywords

CYTOKINE; ENDOTOXIN; LIPOPOLYSACCHARIDE; TUMOR NECROSIS FACTOR;

ANIMAL EXPERIMENT; ARTICLE; CRITICAL ILLNESS; INFECTION; PRIORITY JOURNAL; SEPSIS;

EID: 0029855862     PISSN: 00903493     EISSN: None     Source Type: Journal    
DOI: 10.1097/00003246-199612000-00021     Document Type: Article

References (111)

1. Haynes RB, McKibbon KA, Fitzgerald D, et al: How to keep up with medical literature: III. Expanding the number of journals you read regularly. Ann Intern Med 1986; 105:474-478
2. Fink MP, Homer LD, Fletcher JR: Diminished pressor response to exogenous norepinephrine and angiotensin II in septic, unanesthetized rats: Evidence for a prostaglandin-mediated effect. J Surg Res 1985; 38:335-342
3. American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference Committee: ACCP/ SCCM Consensus Conference: Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 1992; 20:864-874
4. Bone RC, Fisher CJ, Clemmer TP, et al: Sepsis syndrome: A valid clinical entity. Crit Care Med 1989; 17:389-393
5. Le Gall JR, Lemeshow S, Leleu G, et al: Customized probability models for early severe sepsis in adult intensive care patients. Intensive Care Unit Scoring Group. JAMA 1995; 273:644-650
6. Bone RC, Fisher CJ, Clemmer TP, et al: 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
7. Bernard GR, Luce JM, Sprung CL, et al: High-dose corticosteroids in patients with the adult respiratory distress syndrome. N Engl J Med 1987; 317: 1565-1570
8. Ziegler EJ, Fisher CJ Jr, Sprung CL, et al: 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 1991; 324:429-436
9. The Centers for Disease Control: Increase in National Hospital Discharge Survey rates for septicemia - United States, 1979-1987. JAMA 1990; 263:937-938
10. Parrillo JE, Parker MM, Ognibene EP: Septic shock in humans. Advances in the understanding of pathogenesis, cardiovascular dysfunction and therapy. Ann Intern Med 1990; 113:227-242
11. National Center for Health Statistics: Increase in the national hospital discharge survey rates for septicemia - United States. MMWR Morb Mortal Wkly Rep 1990; 39:31-34
12. Friedman G, Gomez J, Shahla M, et al: Mortality from septic shock: Have we made progress? Abstr. Am J Respir Crit Care Med 1995; 151:A494
13. Sibbald WJ, Vincent JL: Round table conference on clinical trials for the treatment of sepsis. Crit Care Med 1995; 23:394-399
14. Guyatt GH, Sackett DL, Cook DJ: Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? JAMA 1994; 271:59-63
15. Oxman AD, Sackett DL, Guyatt GH: Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA 1993; 270:2093-2095
16. Quezado ZM, Natanson C, Hoffman WD: Looking back on HA-1A. Arch Intern Med 1994; 154:2393
17. Freeman BD, Natanson C: Clinical trials in sepsis and septic shock in 1994 and 1995. Current Opinion in Critical Care 1995; 1:349-357
18. Fisher CJ, Cook DJ: Critical evaluation of the design and conduct of previous clinical trials in sepsis. In: Clinical Trials for the Treatment of Sepsis. Sibbald WJ, Vincent J-L (Eds). Berlin, Springer-Verlag, 1995, pp 317-328
19. Teng NN, Kaplan HS, Hebert JM, et al: Protection against Gram-negative bacteremia and endotoxemia with human monoclonal IgM antibodies. Proc Natl Acad Sci U S A 1985; 82:1790-1794
20. Quezado ZM, Natanson C, Alling DW, et al: A controlled trial of HA-1A in a canine model of Gram-negative septic shock. JAMA 1993; 269:2221-2227
21. Bone RC: Systematic evaluation of the critical care literature: A case analysis. J Intensive Care Med 1995; 7:337-338
22. Guyatt GH, Rennie D: Users' guides to the medical literature. JAMA 1993; 270:2096-2097
23. Rennie D: Reporting randomized controlled trials. An experiment and a call for responses from readers. JAMA 1995; 273:1054-1055
24. Horton RC: Literature and medicine: Contributions to clinical practice. JAMA 1995; 123:965
25. Knaus WA, Sun X, Nystrom O, et al: Evaluation of definitions for sepsis. Chest 1992; 101:1656-1662
26. Fisher CJ Jr, Dhainault JA, Opal SM, et al: Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. JAMA 1994; 271:1836-1843
27. Abraham E, Wunderink R, Silverman H, et al: Efficacy and safety of monoclonal antibody to tumor necrosis factor α in patients with sepsis syndrome. A randomized, controlled, double-blind, multicentre clinical trial. JAMA 1995; 273:934-941
28. Mostafa SM, Van Saene H: Sepsis and inflammation: Need for clarification. Intensive Care Med 1994; 20:307
29. Vincent JL, Bihari D: Sepsis, severe sepsis or sepsis syndrome: Need for clarification. Intensive Care Med 1992; 18:255-257
30. Rangel-Frausto MS, Pittet D, Costigan M, et al: The natural history of the systemic inflammatory response syndrome (SIRS). JAMA 1995; 273: 117-123
31. Hayashi S, Gillam IC, Bondy G, et al: Molecular mechanisms of sepsis: Molecular biology of the cell. J Crit Care 1995; 10:82-95
32. Marik PE, Sibbald WJ: Effect of stored-blood transfusion on oxygen delivery in patients with sepsis. JAMA 1993; 269:3024-3029
33. Gatell JM, Trilla A, Latorre X, et al: Nosocomial bacteremia in a large Spanish teaching hospital: Analysis of factors influencing prognosis. Reviews in Infectious Diseases 1988; 10:203-210
34. Gallagher PG, Watanakunakorn C: Pseudomonas bacteremia in a community teaching hospital, 1980-1984. Reviews in Infectious Diseases 1989; 11:846-852
35. Cooper GS, Havlir DS, Shlaes DM, et al: Polymicrobial bacteremia in the late 1980s: Predictors of outcome and review of the literature. Medicine (Baltimore) 1990; 69:114-123
36. Barriere SL, Lowry SF: An overview of mortality risk prediction in sepsis. Crit Care Med 1995; 23:376-393
37. Greenman RL, Schein RM, Martin MA, et al: 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 1991; 266: 1097-1102
38. 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. The E5 Sepsis Study Group. Crit Care Med 1995; 23:994-1006
39. Guyatt GH, Sackett DL, Cook DJ: Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA 1993; 270: 2598-2601
40. Chalmers TC, Celano P, Sacks HS, et al: Bias in treatment assignment in controlled clinical trials. N Engl J Med 1983; 309:1358-1361
41. Colditz GA, Miller JN, Mosteller F: How study design affects outcomes in comparisons of therapy. I: Medical. Stat Med 1989; 8:441-454
42. Sacks H, Chalmers TC, Smith H Jr: Randomized versus historical controls for clinical trials. Am J Med 1982; 72:233-240
43. 2 during peritonitis and shock. Chest 1993; 104: 1254-1258
44. Raper RF, Rutledge FS, Sibbald WJ: Organ blood flow in high output normotensive sepsis. Crit Care Med 1986; 14:440
45. Hinshaw LB, Emerson TE Jr, Taylor FB Jr, et al: Lethal Staphylococcus aureus-induced shock in primates: Prevention of death with anti-TNF antibody. J Trauma 1992; 33:568-573
46. Wichterman KA, Baue AE, Chaudry IH: Sepsis and septic shock - A review of laboratory models and a proposal. J Surg Res 1980; 29:189-201
47. Fink MP, Heard SO: Laboratory models of sepsis and septic shock. J Surg Res 1990; 49:186-196
48. Rangel-Frausto MS, Pittet D, Costigan M, et al: The natural history of the systemic inflammatory response syndrome (SIRS). A prospective study. JAMA 1995; 273:117-123
49. Natanson C, Hoffman WD, Suffredini AF, et al: Selected treatment strategies for septic shock based on proposed mechanisms of pathogenesis. Ann Intern Med 1994; 120:771-783
50. Bagby GJ, Plessala KJ, Wilson LA, et al: Divergent efficacy of antibody to tumor necrosis factor-alpha in intravascular and peritonitis models of sepsis. J Infect Dis 1991; 163:83-88
51. Zanetti G, Heumann D, Gerain J, et al: Cytokine production after intravenous or peritoneal Gram-negative bacterial challenge in mice. Comparative protective efficacy of antibodies to tumor necrosis factor-alpha and to lipopolysaccharide. J Immunol 1992; 148: 1890-1897
52. Echtenacher B, Falk W, Mannel DN, et al: Requirement of endogenous tumor necrosis factor/cachectin for recovery from experimental peritonitis. J Immunol 1990; 145:3762-3766
53. Kollef MH, Wragge T, Pasque C: Determinants of mortality and multiorgan dysfunction in cardiac surgery patients requiring prolonged mechanical ventilation. Chest 1995; 107:1395-1401
54. Tiefenbrun J, Kim SI, Shoemaker WC: The relation of the distribution of pulmonary blood flow to lung function during hemorrhagic shock. Surg Gynecol Obstet 1974; 138:557-561
55. Kim SI, Desai JM, Shoemaker WC: Part II: Sequential respiratory changes in an experimental hemorrhagic shock preparation designed to simulate clinical shock. Ann Surg 1969; 170:166-173
56. Noshima S, Noda H, Herndon DN, et al: Left ventricular performance during continuous endotoxin-induced hyperdynamic endotoxemia in sheep. J Appl Physiol 1993; 74:1528-1533
57. Navaratnam N, Herndon DN, Woodson LC, et al: Endorphin mediation of mesenteric blood flow after endotoxemia in sheep. Crit Care Med 1992; 20: 402-408
58. Navaratnam RL, Morris SE, Traber DL, et al: Endotoxin (LPS) increases mesenteric vascular resistance (MVR) and bacterial translocation (BT). J Trauma 1990; 30:1104-13
59. Suffredini AF, Shelhamer JH, Neumann RD, et al: Pulmonary and oxygen transport effects of intravenously administered endotoxin in normal humans. Am Rev Respir Dis 1992; 145:1398-1403
60. Suffredini AF, Fromm RE, Parker MM, et al: The cardiovascular response of normal humans to the administration of endotoxin. N Engl J Med 1989; 321:280-287
61. Revhaug A, Michie HR, Manson JM, et al: Inhibition of cyclo-oxygenase attenuates the metabolic response to endotoxin in humans. Arch Surg 1988; 123:162-170
62. Suffredini AF, Fromm RE, Parker MM, et al: The cardiovascular response of normal humans to the administration of endotoxin. N Engl J Med 1989; 321:280-287
63. Martich GD, Danner RL, Ceska M, et al: Detection of interleukin 8 and tumor necrosis factor in normal humans after intravenous endotoxin: The effect of antiinflammatory agents. J Exp Med 1991; 173:1021-1024
64. Cannon JG, Tompkins RG, Gelfand JA, et al: Circulating interleukin-1 and tumor necrosis factor in septic shock and experimental endotoxin fever. J Infect Dis 1990; 161:79-84
65. Danner RL, Elin RJ, Hosseini JM, et al: Endotoxemia in human septic shock. Chest 1991; 99:169-175
66. McConnell JS, Cohen J: Release of endotoxin from Escherichia coli by quinolones. J Antimicrob Chemother 1986; 18:765-766
67. Danner RL, Elin RJ, Hosseini JM, et al: Endotoxemia in human septic shock. Chest 1991; 99:169-175
68. Dofferhoff AS, Nijland JH, de Vries-Hospers HG, et al: Effects of different types and combinations of antimicrobial agents on endotoxin release from Gram-negative bacteria: An in vitro and in vivo study. Scand J Infect Dis 1991; 23:745-754
69. Rokke O, Revhaug A, Osterud B, et al: Increased plasma levels of endotoxin and corresponding changes in circulatory performance in a porcine sepsis model: The effect of antibiotic administration. Prog Clin Biol Res 1988; 272:247-262
70. Shenep JL, Barton RP, Mogan KA: Role of antibiotic class in the rate of liberation of endotoxin during therapy for experimental Gram-negative bacterial sepsis. J Infect Dis 1985; 151:1012-1018
71. Baldwin G, Alpert G, Caputo GL, et al: Effect of polymyxin B on experimental shock from meningococcal and Escherichia coli endotoxins. J Infect Dis 1991; 164:542-549
72. Cohen J, Aslam M, Pusey CD, et al: Protection from endotoxemia: A rat model of plasmapheresis and specific adsorption with polymyxin B. J Infect Dis 1987; 155:690-695
73. Foca A, Matera G, Berlinghieri MC, et al: Teicoplanin reduces in vitro reactivity and murine lethality of salmonella minnesota R595 lipopolysaccharide. J Antimicrob Chemother 1992; 29:443-446
74. From AH, Fong JS, Good RA: Polymyxin B sulfate modification of bacterial endotoxin: Effects on the development of endotoxin shock in dogs. Infect Immun 1979; 23:660-664
75. Hughes B, Madan BR, Parratt JR: Polymyxin B sulphate protects cats against the haemodynamic and metabolic effects of E. coli endotoxin. Br J Pharmacol 1981; 74:701-707
76. Jackson JJ, Kropp H: Beta-Lactam antibiotic-induced release of free endotoxin: In vitro comparison of penicillin-binding protein (PBP) 2-specific imipenem and PBP 3-specific ceftazidime. J Infect Dis 1992; 165:1033-1041
77. Walterspiel JN, Kaplan SL, Mason EO Jr: Protective effect of subinhibitory polymyxin B alone and in combination with ampicillin for overwhelming Haemophilus influenzae type B infection in the infant rat: Evidence for in vivo and in vitro release of free endotoxin after ampicillin treatment. Pediatr Res 1986; 20:237-241
78. Palmer JD, Rifkind D: Neutralization of the hemodynamic effects of endotoxin by polymyxin B. Surg Gynecol Obstet 1974; 138:755-759
79. Flynn PM, Shenep JL, Stokes DC, et al: Polymyxin B moderates acidosis and hypotension in established, experimental Gram-negative septicemia. J Infect Dis 1987; 156:706-712
80. Fekety R: Polymyxins. In: Principles and Practice of Infectious Diseases. Third Edition. Mandell GL, Douglas GR, Bennett JE (Eds). New York, Churchill Livingstone, 1995, pp 323-325
81. Redl H, Bahrami S, Schlag G, et al: Clinical detection of LPS and animal models of endotoxemia. Immunobiology 1993; 187:330-345
82. Moore FD Jr, Moss NA, Revhaug A, et al: A single dose of endotoxin activates neutrophils without activating complement. Surgery 1987; 102:200-205
83. Bone RC: Toward an epidemiology and natural, history of SIRS (systemic inflammatory response syndrome). JAMA 1992; 268:3452-3455
84. Shatney CH, Lillehei RC: Serum complement levels in canine endotoxin shock: Relation to survival and to corticosteroid therapy. Adv Shock Res 1983; 9:265-274
85. Nomura S, Harasawa Y, Hayashi S: Antishock effect of U-67,590A, methyl-prednisolone suleptanate, associated with restoration of lowered vascular reactivity in endotoxemic rats. J Cardiovasc Pharmacol 1993; 22: 550-556
86. Zuckerman SH, Bendele AM: Regulation of serum tumor necrosis factor in glucocorticoid-sensitive and -resistant rodent endotoxin shock models. Infect Immun 1989; 57:3009-3013
87. Bone RC, Fisher CJ Jr, Clemmer TP, et al: 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
88. 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
89. The Veterans Administration Systemic Sepsis Cooperative Study Group: Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systemic sepsis. N Engl J Med 1987; 317:659-665
90. Loick HM, Traber LD, Hurst C, et al: Endoscopic laser flowmetry: A valid method for detection and quantitative analysis of inhalation injury. J Burn Care Rehabil 1991; 12:313-318
91. Piper RD, Pill M, Li F, et al: Microcirculatory changes in rat skeletal muscle in sepsis. Am Rev Respir Crit Care Med, In Press
92. Shenep JL, Mogan KA: Kinetics of endotoxin release during antibiotic therapy for experimental Gram-negative bacterial sepsis. J Infect Dis 1984; 150:380-388
93. Corrigan JJ Jr, Kiernat JF: Effect of polymyxin B sulfate on endotoxin activity in a Gram-negative septicemia model. Pediatr Res 1979; 13:48-51
94. Friedland IR, Jafari H, Ehrett S, et al: Comparison of endotoxin release by different antimicrobial agents and the effect on inflammation in experimental Escherichia coli meningitis. J Infect Dis 1993; 168:657-662
95. Mertsola J, Ramilo O, Mustafa MM, et al: Release of endotoxin after antibiotic treatment of Gram-negative bacterial meningitis. Pediatr Infect Dis J 1989; 8:904-906
96. Mustafa MM, Mertsola J, Ramilo O, et al: Increased endotoxin and interleukin-1 beta concentrations in cerebrospinal fluid of infants with coliform meningitis and ventriculitis associated with intraventricular gentamicin therapy. J Infect Dis 1989; 160:891-895
97. Hilf M, Yu VL, Sharp J, et al: Antibiotic therapy for Pseudomonas aeruginosa bacteremia: Outcome correlations in a prospective study of 200 patients. Am J Med 1989; 87:540-546
98. Galanos C, Freudenberg MA: Mechanisms of endotoxin shock and endotoxin hypersensitivity. Immunobiology 1993; 187:346-356
99. Burton RF: Energy and metabolism. In: Physiology By Numbers. New York, Cambridge University Press, 1994, pp 8-23
100. Zweifach BW: Aspects of comparative physiology of laboratory animals relative to the problem of experimental shock. Federation Proceedings 1961; Suppl 9:18-29
101. Nakano Y, Kasahara T, Mukaida N, et al: Protection against lethal bacterial infection in mice by monocyte-chemotactic and -activating factor. Infect Immun 1994; 62:377-383
102. Salyers AA, Whitt DD: Experimental approaches to investigating the host-bacterium interaction. In: Bacterial Pathogenesis. A Molecular Approach. Washington, DC, ASM Press, 1994, pp 73-89
103. Salyers AA, Whitt DD: Escherichia coli gastrointestinal infections. In: Bacterial Pathogenesis. A Molecular Approach. Washington, DC, ASM Press, 1994, pp 190-204
104. Cross AS, Opal SM, Sadoff JC, et al: Choice of bacteria in animal models of sepsis. Infect Immun 1993; 61: 2741-2747
105. Vincent JL, Bihari DJ, Suter PM, et al: The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA 1995; 274:639-644
106. Laupacis A, Sackett DL, Roberts RS: An assessment of clinically useful measures of the consequences of treatment. N Engl J Med 1988; 318:1728-1733
107. Cook DJ: Clinical trials in the treatment of sepsis: An evidence-based approach. In: Clinical Trials for the Treatment of Sepsis. Sibbald WJ, Vincent J-L (Eds). Berlin, Springer-Verlag, 1995, pp XIX-XXXI
108. Hill AB: Principles of Medical Statistics. 9th Edition. New York, Oxford University Press, 1971, pp 309-323
109. Goldie AS, Fearon KC, Ross JA, et al: Natural cytokine antagonists and endogenous antiendotoxin core antibodies in sepsis syndrome. The Sepsis Intervention Group. JAMA 1995; 274: 172-177
110. Marshall JC: Multiple organ dysfunction syndrome (MODS). In: Clinical Trials for the Treatment of Sepsis. Sibbald WJ, Vincent J-L (Eds). Berlin, Springer-Verlag, 1995, pp 123-138
111. Knaus WA, Wagner DP, Harrell FE: What determines prognosis in sepsis? In: Clinical Trials for the Treatment of Sepsis. Sibbald WJ, Vincent J-L (Eds). Berlin, Springer-Verlag, 1995, pp 141-156