Has mortality from sepsis improved and what to expect from new treatment modalities: Review of current insights

Surgical Infections

Volumn 10, Issue 4, 2009, Pages 339-348

  Van Ruler, Oddeke ^a   Schultz, Marcus J ^a   Reitsma, Johannes B ^a   Gouma, Dirk J ^a   Boermeester, Marja A ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ARGININE; CORTICOSTEROID; DROTRECOGIN; GLUTAMINE; INSULIN; NUCLEOTIDE; OMEGA 3 FATTY ACID; ANTIINFECTIVE AGENT; PROTEIN C;

ADULT RESPIRATORY DISTRESS SYNDROME; ANTIBIOTIC RESISTANCE; ANTIBIOTIC THERAPY; ANTICOAGULANT THERAPY; ARTIFICIAL VENTILATION; BLOODSTREAM INFECTION; CLINICAL TRIAL; CORTICOSTEROID THERAPY; COST EFFECTIVENESS ANALYSIS; CRITICALLY ILL PATIENT; DRUG EFFICACY; ENTERIC FEEDING; ERYTHROCYTE TRANSFUSION; HEMODYNAMICS; HUMAN; HYPERGLYCEMIA; INSULIN TREATMENT; INTENSIVE CARE UNIT; LOW DRUG DOSE; MORTALITY; PRIORITY JOURNAL; REVIEW; SEPSIS; SYSTEMATIC REVIEW; TRACHEOSTOMY; INTENSIVE CARE; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL; TIME;

ANTI-BACTERIAL AGENTS; HUMANS; INSULIN; INTENSIVE CARE; PROTEIN C; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SEPSIS; TIME FACTORS;

EID: 70350028681     PISSN: 10962964     EISSN: None     Source Type: Journal    
DOI: 10.1089/sur.2008.012     Document Type: Review

References (96)

1. Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med 2003;348:1546-1554.
2. Schellekens JFP, Verburgh HA. Sepsis. RIVM Nationaal Kompas Volksgezondheid 2007. Available at http:==www .rivm.nl=vtv=object-class=kom- sepsis.html
3. Finfer S, Bellomo R, Lipman J, et al. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med 2004;30:589-596.
4. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001;29:1303-1310.
5. Marshall JC. Clinical trials of mediator-directed therapy in sepsis: What have we learned? Intensive Care Med 2000; 26(Suppl 1):S75-S83.
6. Barie PS. Surviving sepsis. Surg Infect 2004;5:1-2.
7. Beilman GJ. New strategies to improve outcomes in the surgical intensive care unit. Surg Infect 2004;5:289-300.
8. Gluck T, Opal SM. Advances in sepsis therapy. Drugs 2004;64:837-859.
9. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med 2004;32:858-873. (Pubitemid 38344143)
10. van Houwelingen HC, Arends LR, Stijnen T. Advanced methods in meta-analysis: Multivariate approach and metaregression. Stat Med 2002;21:589-624.
11. Abraham E, Wunderink R, Silverman H, et al. Efficacy and safety of monoclonal antibody to human tumor necrosis factor alpha in patients with sepsis syndrome: A randomized, controlled, double-blind, multicenter clinical trial. TNF-alpha MAb Sepsis Study Group. JAMA 1995;273:934-941.
12. Abraham E, Glauser MP, Butler T, et al. p55 Tumor necrosis factor receptor fusion protein in the treatment of patients with severe sepsis and septic shock: A randomized controlled multicenter trial. Ro 45-2081 Study Group. JAMA 1997;277:1531-1538.
13. Abraham E, Anzueto A, Gutierrez G, et al. Double-blind randomised controlled trial of monoclonal antibody to human tumour necrosis factor in treatment of septic shock. NORASEPT II Study Group. Lancet 1998;351:929-933.
14. Abraham E, Reinhart K, Svoboda P, et al. Assessment of the safety of recombinant tissue factor pathway inhibitor in patients with severe sepsis: A multicenter, randomized, placebo-controlled, single-blind, dose escalation study. Crit Care Med 2001;29:2081-2089.
15. Abraham E, Laterre PF, Garbino J, et al. Lenercept (p55 tumor necrosis factor receptor fusion protein) in severe sepsis and early septic shock: A randomized, double-blind, placebo-controlled, multicenter Phase III trial with 1,342 patients. Crit Care Med 2001;29:503-510.
16. Abraham E, Reinhart K, Opal S, et al. Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: A randomized controlled trial. JAMA 2003;290:238-247.
17. Angus DC, Birmingham MC, Balk RA, et al. E5 murine monoclonal antiendotoxin antibody in gram-negative sepsis: A randomized controlled trial. E5 Study Investigators. JAMA 2000;283:1723-1730.
18. Annane D, Sebille V, Charpentier C, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002;288:862-871.
19. Baudo F, Caimi TM, de Cataldo F, et al. Antithrombin III (ATIII) replacement therapy in patients with sepsis and=or postsurgical complications: A controlled double-blind, randomized, multicenter study. Intensive Care Med 1998;24: 336-342.
20. Bernard GR, Wheeler AP, Russell JA, et al. The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group. N Engl J Med 1997;336:912-918.
21. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001;344:699-709.
22. 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.
23. 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.
24. Cohen J, Carlet J. INTERSEPT: An international, multicenter, placebo-controlled trial of monoclonal antibody to human tumor necrosis factor-alpha in patients with sepsis. International Sepsis Trial Study Group. Crit Care Med 1996;24:1431-1440.
25. Dhainaut JF, Tenaillon A, Hemmer M, et al. Confirmatory platelet-activating factor receptor antagonist trial in patients with severe gram-negative bacterial sepsis: A Phase III, randomized, double-blind, placebo-controlled, multicenter trial. BN 52021 Sepsis Investigator Group. Crit Care Med 1998;26:1963-1971.
26. Dhainaut JF, Laterre PF, Janes JM, et al. Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial. Intensive Care Med 2003;29:894-903.
27. Fisher CJ Jr, Dhainaut JF, 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. Phase III rhIL-1ra Sepsis Syndrome Study Group. JAMA 1994;271:1836-1843.
28. Fisher CJ Jr, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor:Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med 1996;334:1697-1702.
29. Galban C, Montejo JC, Mesejo A, et al. An immuneenhancing enteral diet reduces mortality rate and episodes of bacteremia in septic intensive care unit patients. Crit Care Med 2000;28:643-648.
30. 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.
31. Lopez A, Lorente JA, Steingrub J, et al. Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: Effect on survival in patients with septic shock. Crit Care Med 2004;32:21-30.
32. McCloskey RV, Straube RC, Sanders C, et al. Treatment of septic shock with human monoclonal antibody HA-1A: A randomized, double-blind, placebo-controlled trial. CHESS Trial Study Group. Ann Intern Med 1994;121:1-5.
33. Opal SM, Fisher CJ Jr, Dhainaut JF, et al. 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 1997;25:1115-1124.
34. Panacek EA, Marshall JC, Albertson TE, et al. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab0)2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med 2004;32: 2173-2182.
35. Reinhart K, Menges T, Gardlund B, et al. Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study. Crit Care Med 2001;29:765-769.
36. Rivers EP, Nguyen HB, Huang DT, Donnino M. Early goaldirected therapy. Crit Care Med 2004;32:314-315.
37. Warren BL, Eid A, Singer P, et al. Caring for the critically ill patient: High-dose antithrombin III in severe sepsis: A randomized controlled trial. JAMA 2001;286:1869-1878.
38. Ziegler EJ, Fisher CJ Jr, Sprung CL, et al. Treatment of gramnegative 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.
39. Marshall JC, Maier RV, Jimenez M, Dellinger EP. Source control in the management of severe sepsis and septic shock: An evidence-based review. Crit Care Med 2004;32:S513-S526.
40. Jimenez MF, Marshall JC. Source control in the management of sepsis. Intensive Care Med 2001;27:49-62.
41. Ibrahim EH, Sherman G, Ward S, et al. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest 2000;118:146-155.
42. Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: A risk factor for hospital mortality among critically ill patients. Chest 1999;115:462-474.
43. Barie PS, Hydo LJ, Shou J, et al. Influence of antibiotic therapy on mortality of critical surgical illness caused or complicated by infection. Surg Infect 2005;6:41-54.
44. de Jonge E, Schultz MJ, Spanjaard L, et al. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care: A randomised controlled trial. Lancet 2003;362:1011-1016.
45. Heininger A, Meyer E, Schwab F, et al. Effects of long-term routine use of selective digestive decontamination on antimicrobial resistance. Intensive Care Med 2006;32:1569-1576.
46. Messmer KF. Acceptable hematocrit levels in surgical patients. World J Surg 1987;11:41-46.
47. Blajchman MA. Transfusion-associated immunomodulation and universal white cell reduction: Are we putting the cart before the horse? Transfusion 1999;39:665-670.
48. Busch OR, Hop WC, Hoynck van Papendrecht MA, et al. Blood transfusions and prognosis in colorectal cancer. N Engl J Med 1993;328:1372-1376.
49. Hebert PC. Transfusion requirements in critical care (TRICC): A multicentre, randomized, controlled clinical study. Transfusion Requirements in Critical Care Investigators and the Canadian Critical Care Trials Group. Br J Anaesth 1998;81:25-33.
50. Prigent H, Maxime V, Annane D. Clinical review: Corticotherapy in sepsis. Crit Care 2004;8:122-129.
51. Prigent H, Maxime V, Annane D. Science review: Mechanisms of impaired adrenal function in sepsis and molecular actions of glucocorticoids. Crit Care 2004;8:243-252.
52. Burke CW. Adrenocortical insufficiency. Clin Endocrinol Metab 1985;14:947-976.
53. Annane D, Bellissant E, Bollaert PE, et al. Corticosteroids for severe sepsis and septic shock: A systematic review and meta-analysis. BMJ 2004;329:480.
54. Sprung CL, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl JMed 2008;358:111-124.
55. Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients. N Engl J Med 2001;345:1359-1367.
56. Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medical ICU. N Engl J Med 2006;354:449-461.
57. Brunkhorst F, Kuhnt E, Engel C, et al. Intensive insulin therapy in patients with severe sepsis and septic shock is associated with an increased rate of hypoglycemia: Results from a randomized multicenter study (VISEP). Infection 2005;33:19-20.
58. Marik PE, Varon J. Intensive insulin therapy in the ICU: Is it now time to jump off the bandwagon? Resuscitation 2007; 74:191-193.
59. Mackenzie I, Ingle S, Zaidi S, Buczaski S. Hypoglycaemia? So what! Intensive Care Med 2006;32:620-621.
60. Vriesendorp TM, DeVries JH, van Santen S, et al. Evaluation of short-term consequences of hypoglycemia in an intensive care unit. Crit Care Med 2006;34:2714-2718. (Pubitemid 44610935)
61. Bernard GR, Ely EW, Wright TJ, et al. Safety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis. Crit Care Med 2001;29:2051-2059.
62. Payen D, Sablotzki A, Barie PS, et al. International integrated database for the evaluation of severe sepsis and drotrecogin alfa (activated) therapy: Analysis of efficacy and safety data in a large surgical cohort. Surgery 2007;141:548-561.
63. De Pont ACJM, Bakx R, Boermeester MA, Schultz MJ. Analysis of efficacy and safety of drotrecogin alpha (activated) in surgical patients using an international integrated database. Surgery 2007;141:828-829.
64. Manns BJ, Lee H, Doig CJ, et al. An economic evaluation of activated protein C treatment for severe sepsis. N Engl J Med 2002;347:993-1000.
65. Angus DC, Linde-Zwirble WT, Clermont G, et al. Costeffectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis. Crit Care Med 2003;31:1-11.
66. Kanji S, Perreault MM, Chant C, et al. Evaluating the use of drotrecogin alfa (activated) in adult severe sepsis: A Canadian multicenter observational study. Intensive Care Med 2007;33:517-523.
67. Bertolini G, Iapichino G, Radrizzani D, et al. Early enteral immunonutrition in patients with severe sepsis: Results of an interim analysis of a randomized multicentre clinical trial. Intensive Care Med 2003;29:834-840.
68. Heyland DK, Novak F, Drover JW, et al. Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA 2001;286:944-953.
69. Eichacker PQ, Gerstenberger EP, Banks SM, et al. Metaanalysis of acute lung injury and acute respiratory distress syndrome trials testing low tidal volumes. Am J Respir Crit Care Med 2002;166:1510-1514.
70. The Acute Respiratory Distress Syndrome Network. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 2000;342:1301-1308.
71. Steinbrook R. How best to ventilate? Trial design and patient safety in studies of the acute respiratory distress syndrome. N Engl J Med 2003;348:1393-1401.
72. Hager DN, Krishnan JA, Hayden DL, Brower RG. Tidal volume reduction in patients with acute lung injury when plateau pressures are not high. Am J Respir Crit Care Med 2005;172:1241-1245.
73. Brower RG, Lanken PN, MacIntyre N, et al. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med 2004;351:327-336.
74. Guerin C, Gaillard S, Lemasson S, et al. Effects of systematic prone positioning in hypoxemic acute respiratory failure: A randomized controlled trial. JAMA 2004;292:2379-2387.
75. Gattinoni L, Tognoni G, Pesenti A, et al. Effect of prone positioning on the survival of patients with acute respiratory failure. N Engl J Med 2001;345:568-573.
76. Spronk PE, Schultz MJ. Is prone positioning reaching a turning point? Netherlands J Crit Care 2007;9:77.
77. Rumbak MJ, Newton M, Truncale T, et al. A prospective, randomized, study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Crit Care Med 2004;32:1689-1694.
78. Dongelmans DA, Schultz MJ. Early or late tracheostomy. Crit Care Med 2005;33:466.
79. Schultz MJ, Veelo DP, Spronk PE. Timing of tracheostomy in adult patients: Conclusions may be premature. BMJ 2005;331:404-405.
80. Pronovost PJ, Angus DC, Dorman T, et al. Physician staffing patterns and clinical outcomes in critically ill patients: A systematic review. JAMA 2002;288:2151-2162.
81. Breslow MJ, Rosenfeld BA, Doerfler M, et al. Effect of a multiple-site intensive care unit telemedicine program on clinical and economic outcomes: An alternative paradigm for intensivist staffing. Crit Care Med 2004;32:31-38.
82. Hugonnet S, Villaveces A, Pittet D. Nurse staffing level and nosocomial infections: Empirical evaluation of the casecrossover and case-time-control designs. Am J Epidemiol 2007;165:1321-1327.
83. Brun-Buisson C, Meshaka P, Pinton P, Vallet B. EPISEPSIS: A reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med 2004;30:580-588.
84. Friedman G, Silva E, Vincent JL. Has the mortality of septic shock changed with time. Crit Care Med 1998;26:2078-2086.
85. Vincent JL. Steroids in sepsis: Another swing of the pendulum in our clinical trials. Crit Care 2008;12:141.
86. Groeneveld AB, Molenaar N, Beishuizen B. Should we abandon corticosteroids during septic shock? No. Curr Opin Crit Care 2008;14:384-389.
87. Stuber F. Effects of genomic polymorphisms on the course of sepsis: Is there a concept for gene therapy? J Am Soc Nephrol 2001;12:60-64.
88. Papathanassoglou ED, Giannakopoulou MD, Bozas E. Genomic variations and susceptibility to sepsis. AACN Adv Crit Care 2006;17:394-422.
89. Arcaroli J, Fessler MB, Abraham E. Genetic polymorphisms and sepsis. Shock 2005;24:300-312.
90. Clark MF, Baudouin SV. A systematic review of the quality of genetic association studies in human sepsis. Intensive Care Med 2006;32:1706-1712.
91. Grossi P, Gasperina DD. Antimicrobial treatment of sepsis. Surg Infect 2006;7:87-91.
92. Schultz MJ, Royakkers AA, Levi M, et al. Intensive insulin therapy in intensive care: An example of the struggle to implement evidence-based medicine. PLoS Med 2006; 3:456.
93. Schultz MJ, Wolthuis EK, Moeniralam HS, Levi M. Struggle for implementation of new strategies in intensive care medicine: Anticoagulation, insulin, and lower tidal volumes. J Crit Care 2005;20:199-204.
94. Nguyen HB, Corbett SW, Steele R, et al. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med 2007;35:1105-1112.
95. Schlichting D, McCollam JS. Recognizing and managing severe sepsis: A common and deadly threat. South Med J 2007;100:594-600.
96. Kahn JM, Rubenfeld GD. Translating evidence into practice in the intensive care unit: The need for a systems-based approach. J Crit Care 2005;20:204-206.