A new method for removing endotoxin from plasma using hemocompatible affinity chromatography technology, applicable for extracorporeal treatment of septic patients

Journal of Endotoxin Research

Volumn 10, Issue 2, 2004, Pages 85-95

  Amoureux, Marie Claude ^a   Hegyi, Edit ^a   Le, Dzung ^a   Grandics, Peter ^a   Tong, Hung ^a   Szathmary, Susan ^a  

^a Clarigen Inc   (United States)

Author keywords

Endotoxin; Extracorporeal treatment; Hemocompatible affinity chromatography; Plasma; Septic patients

Indexed keywords

COMPLEMENT; ENDOTOXIN; FIBRINOGEN; OFLOXACIN; PROTHROMBIN; RESIN; THROMBIN ANTITHROMBIN COMPLEX; THROMBOPLASTIN; TUMOR NECROSIS FACTOR ALPHA;

AFFINITY CHROMATOGRAPHY; ARTICLE; BACTERIUM CULTURE; BLOOD CLOTTING TEST; CELL ACTIVATION; CELL ASSAY; COMPLEMENT ACTIVATION; CONTROLLED STUDY; ESCHERICHIA COLI; EXTRACORPOREAL CIRCULATION; HEMOSTASIS; HUMAN; HUMAN CELL; LIMULUS LYSATE TEST; MEDICAL INSTRUMENTATION; MEDICAL TECHNOLOGY; METHODOLOGY; MONOCYTE; NONHUMAN; PARTIAL THROMBOPLASTIN TIME; PLASMA; PROTHROMBIN TIME; PROVOCATION TEST; SCALE UP; SEPSIS; STENOTROPHOMONAS MALTOPHILIA; SUPERNATANT;

BLOOD COAGULATION TESTS; CHROMATOGRAPHY, AFFINITY; ENDOTOXINS; ENZYME-LINKED IMMUNOSORBENT ASSAY; ESCHERICHIA COLI; HUMANS; PSEUDOMONAS; RENAL DIALYSIS; SEPSIS; TUMOR NECROSIS FACTOR-ALPHA;

NEGIBACTERIA;

EID: 2342419214     PISSN: 09680519     EISSN: None     Source Type: Journal    
DOI: 10.1179/096805104225003834     Document Type: Article

References (69)

1. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associated costs of care. Crit Care Med 2001; 29: 1303-1310.
2. Cohen J, Carlet J. Intersept: an international, multicenter, placebo controlled trial of monoclonal antibody to human tumor necrosis factor-a in patients with sepsis. Crit Care Med 1996; 24: 1431-1440.
3. Dhainaut JFA, Vincent JL, Richard C. CDP571, a humanized antibody to human tumor necrosis factor-α: safety, pharmacokinetics, immune response, and influence of the antibody on cytokine concentrations in patients with septic shock. Crit Care Med 1995; 23: 1461-1469.
4. Dhainaut JFA, Mira JP, Brunet F. Platelet-activating factor receptor antagonist BM 52021 in the treatment of severe sepsis: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Crit Care Med 1994; 22: 1720-1728.
5. Fein AM, Bernard GR, Criner GJ et al. Treatment of severe systemic inflammatory response syndrome and sepsis with a novel bradykinin antagonist, deltibant (CP-0127). JAMA 1997; 277: 482-487.
6. Fisher Jr CJ, Opal SM, Dhainaut JF et al. Influence of an antitumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis. Crit Care Med 1993; 21: 318-327.
7. Fisher Jr CJ, Dhainaut JF, Opal SM et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. JAMA 1994; 271: 1836-1843.
8. Fisher Jr 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-label, placebo-controlled multicenter trial. Crit Care Med 1994; 22: 12-21.
9. Haupt MT, Jastremski MS, Clemmer TP et al. Effect of ibuprofen in patients with severe sepsis: a randomized, double-blind, multicenter study. The Ibuprofen Study Group. Crit Care Med 1991; 19: 1339-1347.
10. Opal SM, Fisher Jr CJ, Dhainaut JF et al. Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Crit Care Med 1997; 25: 1115-1124.
11. 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: 733-792.
12. Schulze C, Oesser S, Hein H, Seifert J. Risk of endotoxemia during the initial phase of gut decontamination with antimicrobial agents. Res Exp Med 2001; 200: 169-174.
13. Lepper PM, Held TK, Schneider EM, Bolke E, Gerlach H, Trautmann M. Clinical implications of antibiotic-induced endotoxin release in septic shock. Intensive Care Med 2002; 28: 824-833.
14. 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.
15. Opal SM. The clinical relevance of endotoxin in human sepsis: a critical analysis. J Endotoxin Res 2002; 8: 473-476.
16. Verbon A, Meijers JC, Spek CA et al. Effects of IC14, an anti-CD14 antibody, on coagulation and fibrinolysis during low-grade endotoxemia in humans. J Infect Dis 2003; 187: 55-61.
17. Stegmayr BG. Is there a future for adsorption techniques in sepsis? Blood Purif 2000; 18: 149-155.
18. Wright SD, Ramos RA, Tobias PS, Ulevitch RJ, Mathison JC. CD14, a receptor for complexes of lipopolysaccharide (LPS) and LPS binding protein. Science 1990; 249: 1431-1433.
19. Hoshino K, Takeuchi O, Kawai T et al. Cutting edge: Toll-like receptor 4 (TLR4)-deficient mice are hyporesponsive to lipopolysaccharide: evidence for TLR4 as the Lps gene product. J Immunol 1999; 162: 3749-3752.
20. Kitchens RL, Thompson PA, O'Keefe GE, Munford RS. Plasma constituents regulate LPS binding to, and release from, the monocyte cell surface. J Endotoxin Res 2000; 6: 477-482.
21. Geppert TD, Whitehurst CE, Thompson P, Beutler B. Lipopolysaccharide signals activation of tumor necrosis factor biosynthesis through the ras/raf-1/MEK/MAPK pathway. Mol Med 1994; 1: 93-103.
22. Horng T, Medzhitov R. Drosophila MyD88 is an adapter in the Toll signaling pathway. Proc Natl Acad Sci USA 2001; 98: 12654-12658.
23. Suzuki N, Suzuki S, Duncan GS et al. Severe impairment of interleukin-1 and Toll-like receptor signalling in mice lacking IRAK-4. Nature 2002; 416: 750-756.
24. Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med 2003; 348: 138-150.
25. Miyashima T, Hayashi K, Awai M. Initiation and recovery process of endotoxin induced disseminated intravascular coagulation (DIC): scanning and transmission electron microscopic observations of rat renal tissues. Acta Med Okayama 1989; 43: 115-126.
26. Van der Poll T, de Jonge E, Levi M. Regulatory role of cytokines in disseminated intravascular coagulation. Semin Thromb Hemost 2001; 27: 639-651.
27. Van der Poll T. Coagulation and inflammation. J Endotoxin Res 2001; 7: 301-304.
28. ten Cate JW, van der Poll T, Levi M, ten Cate H, van Deventer SJ. Cytokines: triggers of clinical thrombotic disease. Thromb Hemost 1997; 78: 415-419.
29. Magder S, Javeshghani D, Cernacek P, Giaid A. Distribution of endothelin-1 and endothelin converting enzyme-1 in porcine endotoxemia. Shock 2001; 16: 320-325.
30. Opal SM, Scannon PJ, Vincent JL et al. Relationship between plasma levels of lipopolysaccharide (LPS) and LPS-binding protein in patients with severe sepsis and septic shock. J Infect Dis 1999; 180: 1584-1589.
31. Brandtzaeg P, Kierulf P, Gaustad P et al. Plasma endotoxin as a predictor of multiple organ failure and death in systemic meningococcal disease. J Infect Dis 1989; 159: 195-204.
32. Bates DW, Parsonnet J, Ketchum PA et al. Limulus amebocyte lysate assay for detection of endotoxin in patients with sepsis syndrome. AMCC Sepsis Project Working Group. Clin Infect Dis 1998; 27: 582-591.
33. Casey LC, Balk RA, Bone RC. Plasma cytokine and endotoxin levels correlate with survival in patients with the sepsis syndrome. Ann Intern Med 1993; 119: 771-778.
34. Marshall JC, Walker PM, Foster DM et al. Measurement of endotoxin activity in critically ill patients using whole blood neutrophil dependent chemiluminescence. Crit Care 2002; 6: 342-348.
35. Yamamoto H. Direct hemoperfusion with polymyxin B-immobilized fiber improves shock and hypoxemia during endotoxemia in anesthetized sheep. J Endotoxin Res 2002; 8: 419-426.
36. Aoki H, Kodama M, Tani T, Hanasawa K. Treatment of sepsis by extracorporeal elimination of endotoxin using polymyxin B-immobilized fiber. Am J Surg 1994; 167: 412-417.
37. Cheadle WG, Hanasawa K, Gallinaro RN et al. Endotoxin filtration and immune stimulation improve survival from Gram-negative sepsis. Surgery 1991; 110: 785-791.
38. Shimada N, Abe S, Hisiki T et al. Reduction of plasma nitric oxide in a patient with endotoxic shock by hemoadsorption therapy. Nephron 1997; 75: 115.
39. Schimke J, Mathison J, Morgiewicz J, Ulevitch RJ. Anti-CD14 mAb treatment provides therapeutic benefit after in vivo exposure to endotoxin. Proc Natl Acad Sci USA 1998; 95: 13875-13880.
40. Krehmeier U, Bardenheuer M, Voggenreiter G, Obertacke U, Schade FU, Majetschak M. Effects of antimicrobial agents on spontaneous and endotoxin-induced cytokine release of human peripheral blood mononuclear cells. J Infect Chemother 2002; 8: 194-197.
41. Warren HS, Novitsky TJ, Ketchum PA, Roslansky PF, Kania S, Siber GR. Neutralization of bacterial lipopolysaccharides by human plasma. J Clin Microbiol 1985; 22: 590-595.
42. Kodama M, Aoki H, Tani T and Hanasawa K. Hemoperfusion using Polymycin B immobilized fiber column for the removal of endotoxin. In: Levin J, Alving CR, Munford RS, Stutz PL. (eds) Bacterial Endotoxin: Recognition and Effector Mechanisms. Amsterdam:Elsevier Science Publishers, 1993; 389-398.
43. Kitchens RL, Munford RS. CD14-dependent internalization of bacterial lipopolysaccharide (LPS) is strongly influenced by LPS aggregation but not by cellular responses to LPS. J Immunol 1998; 160: 1920-1928.
44. Kitchens RL, Thompson PA, Viriyakosol S, O'Keefe GE, Munford RS. Plasma CD14 decreases monocyte responses to LPS by transferring cell-bound LPS to plasma lipoproteins. J Clin Invest 2001; 108: 485-493.
45. Levin J, Tomasulo PA, Oser RS. Detection of endotoxin in human blood and demonstration of an inhibitor. J Lab Clin Med 1970; 75: 903-911.
46. Roth RI, Su D, Child AH, Wainwright NR, Levin J. Limulus antilipopolysaccharide factor prevents mortality late in the course of endotoxemia. J Infect Dis 1998; 177: 388-394.
47. Novitsky TJ, Limitations of the Limulus amebocyte lysate test in demonstrating circulating lipopolysaccharides. Ann NY Acad Sci 1998; 851: 416-421.
48. Berlot G, Lucangelo U, Galimberti G, Sganga G. Plasmapheresis in sepsis. Contrib Nephrol 2001; 132: 391-399.
49. Stegmayr BG. Apheresis as therapy for patients with severe sepsis and multiorgan dysfunction syndrome. Ther Apheresis 2001; 5: 123-127.
50. Tetta C, Gianotti L, Cavaillon JM et al. Coupled plasma filtration-adsorption in a rabbit model of endotoxic shock. Crit Care Med 2000; 28: 1526-1533.
51. Tetta C, Bellomo R, Brendolan A et al. Use of adsorptive mechanisms in continuous renal replacement therapies in the critically ill. Kidney Int Suppl 1999; 72: S15-S19.
52. Samtleben W, Randerson DH, Blumenstein M, Habersetzer R, Schmidt B, Gurland HJ. Membrane plasma exchange: principles and application techniques. J Clin Apheresis 1984; 2: 163-169.
53. Hurley JC. Endotoxemia: methods of detection and clinical correlates. Clin Microbiol Rev 1995; 8: 268-292.
54. Pearson FC, Dubczak J, Weary M, Bruszer G. Donohue G. Detection of endotoxin in the plasma of patients with Gram-negative bacterial sepsis by the Limulus amebocyte lysate assay. J Clin Microbiol 1985; 21: 865-868.
55. Baggerman C, Pathmamanoharan C, Spies F, Joosten JG, Junginger HE. Physicochemical properties of endotoxins in large volume parenterals. J Pharm Pharmacol 1985; 37: 521-527.
56. Aurell CA, Wistrom AO. Critical aggregation concentrations of Gram-negative bacterial lipopolysaccharides (LPS). Biochem Biophys Res Commun 1998; 253: 119-123.
57. Shalaby MR, Waage A, Aarden L, Espevik T. An overview of the history and biologic properties of tumor necrosis factors. Spring Semin Immunopathol 1986; 9: 33-37.
58. Tracey KJ, Cerami A. Tumor necrosis factor: an update review of its biology. Crit Care Med 1993; 21: 415-422.
59. Ash SR, Steczko J, Levy H, Blake DE, Carr DJ. Treatment of systemic inflammatory response syndrome by push-pull powdered sorbent apheresis: a Phase 1 clinical trial. Ther Apheresis 2001; 5: 497-505.
60. Zimmermann M, Busch K, Kuhn S, Zeppezauer M. Endotoxin adsorbent based on immobilized human serum albumin. Clin Chem Lab Med 1999; 37: 373-379.
61. Kluger MJ, Singer R, Eiger SM. Polymyxin B use does not ensure endotoxin-free solution. J Immunol Methods 1985; 83: 201-207.
62. Tani T, Hanasawa K, Endo Y et al. Therapeutic apheresis for septic patients with organ dysfunction: hemoperfusion using a polymyxin B immobilized column. Artif Organs 1998; 12: 1038-1044.
63. Nemoto H, Nakamoto H, Okada H et al. Newly developed immobilized polymyxin B fibers improve the survival of patients with sepsis. Blood Purif 2001; 19: 361-368.
64. Nakamura T, Ebihara I, Shimada N, Koide H. Changes in plasma erythropoietin and interleukin-6 concentrations in patients with septic shock after hemoperfusion with polymyxin B-immobilized fiber. Intensive Care Med 1998; 24: 1272-1276.
65. Aoki H, Kodama M, Tani T, Hanasawa K. Treatment of sepsis by extracarporeal elimination of endotoxin using polymyxin B-immobilized fiber. Am J Surg 1994; 167: 412-417.
66. Andersson M, Girard R, Cazenave P. Interaction of NK lysin, a peptide produced by cytolytic lymphocytes, with endotoxin. Infect Immun 1999; 67: 201-205.
67. Boos KS, Siedel D, von der Haar F. Process for the quantitative selective removal or preparative isolation of tumour necrosis factor (TNF) or/and lipopolysaccharides (LPS) from aqueous liquids, US patent 5,403,917,1993.
68. von Appen K, Weber C, Losert U, Schima H, Gurland HJ, Falkenhagen D. Microspheres based detoxification system: a new method in convective blood purification. Artif Organs 1996; 20: 420-425.
69. Samtleben W, Bengsch S, Boos KS, Seidel D. HELP apheresis in the treatment of sepsis. Artif Organs 1998; 22: 43-46.