Hemofiltration pp 101-113 | Cite as

Substitution Fluid for Hemofiltration

  • G. M. Eisenbach
  • S. Shaldon


New therapies in medicine offer benefits but often have inherent dangers which are only evident after the passage of time has tempered initial enthusiasm. Since the introduction of long-term end-stage renal therapy in 1960, the patient has been exposed to increasingly larger volumes of parenteral fluids. Thus, the patient on hemodialysis and hemodiafiltration is exposed to 25 000 1 of dialysate fluid per year, while the patient on hemofiltration or peritoneal dialysis receives only about 5000 1 per annum. As there are now patients alive who have undergone 20 years of hemodialysis and 10 years of hemofiltration or peritoneal dialysis, the cumulative magnitude of trace contamination with toxic elements of these fluids and its subsequent effect on the patient are slowly becoming better understood.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Lewins R (1831) Injection of saline solution in extraordinary quantities into the veins in cases of malignant cholera. Lancet ii: 243–244Google Scholar
  2. 2.
    Pharmacopeia of the United States of America, 12th Revision (USPXII). From Nov.1, 1942, Easton, Pa.Google Scholar
  3. 3.
    Duma RJ, Warner JF, Dalton HP (1971) Septicemia from intravenous infusions. N Engl J Med 284: 257PubMedCrossRefGoogle Scholar
  4. 4.
    Felts SK, Schaffner W, Melli MA, Koenig MG (1972) Sepsis caused by contaminated intravenous fluids. Ann Intern Med 77: 881PubMedCrossRefGoogle Scholar
  5. 5.
    Maki DG, Goldman DA, Rhame FS (1973) Infection control in intravenous therapy. Ann Intern Med 9: 867CrossRefGoogle Scholar
  6. 6.
    Meers PD, Calder MW, Mazhar MM, Lawry GM (1973) Intravenous infusion of contaminated dextrose solution. Lancet ii: 1189CrossRefGoogle Scholar
  7. 7.
    Mackel DC, Maki G, Anderson RL, Rhame TS, Bennet JV (1975) Nationwide epidemic of septicemia caused by by contaminated intravenous products: Mechanisms of intrinsic contamination. J Clin Microbiol 2: 486PubMedCentralPubMedGoogle Scholar
  8. 8.
    Maki DG, Rhame FS, Mackel DC, Bennet JV (1976) Nationwide epidemic of septicemia caused by contaminated intravenous products. Am J Med 60: 471PubMedCrossRefGoogle Scholar
  9. 9.
    Editorial (1976) Thomas Latta, what have we done? — The hazards of intravenous therapy. N Engl J Med 294: 1178–1180CrossRefGoogle Scholar
  10. 10.
    Maki DG (1981) Nosocomial bacteremia. An epidemiologic overview. Am J Med 70: 719–732PubMedCrossRefGoogle Scholar
  11. 11.
    Report of the Comptroller General the US (1976) Recalls of large volume parenterals (Liquid drugs administered intravenously or by other non-oral means). March 12, 1976 (MSD-76-67)Google Scholar
  12. 12.
    Frei U, Koch KM (1983) Fever and shock during hemofiltration. Contrib Nephrol 36: 107–114PubMedGoogle Scholar
  13. 13.
    Snell ES (1975) Gram-negative bacterial endotoxin and the pathogenesis of fever. Prog Drug Res 19: 402–411PubMedGoogle Scholar
  14. 14.
    Dinarello CA, Wolff SM (1978) Pathogenesis of fever in man. N Engl Med 298: 607–612CrossRefGoogle Scholar
  15. 15.
    Morrison DC, Ulevitch RJ (1978) The effects of bacterial endotoxins in host mediation systems. Am J Pathol 93: 527–617Google Scholar
  16. 16.
    Dinarello CA (1983) Pathogenesis of fever during hemodialysis. Contrib Nephrol 36: 90–99PubMedGoogle Scholar
  17. 17.
    Dinarello CA, Wolff SM (1982) Molecular basis of fever in humans. Am J Med 72: 799–819PubMedCrossRefGoogle Scholar
  18. 18.
    Levin J, Bang FB (1964) The role of endotoxin in the extracellular coagulation of Limulus blood. Bull John Hopkins Hosp 115: 265–274PubMedGoogle Scholar
  19. 19.
    Levin J, Bang FB (1964) A description of cellular coagulation in the Limulus. Bull John Hopkins Hosp 115: 337PubMedGoogle Scholar
  20. 20.
    Nandan R, Brown DR (1977) An improved in vitro pyrogen test: To detect picograms of endotoxin contamination in intravenous fluids using Limulus amebocyte lysate. J Lab Clin Med 89: 910–918PubMedGoogle Scholar
  21. 21.
    Dubczak J, Cotter R, Dastoli F (1979) Quantitative detection of endotoxin by nephelometry. In: Cohen E (ed) Biomedical applications of the horseshoe crab (Limulidae). Liss, New York, pp 403Google Scholar
  22. 22.
    Gardi A, Arpagaus GR (1980) Improved microtechnique for endotoxin assay by the limulus amebocyte lysate test. Anal Biochem 109: 382–385PubMedCrossRefGoogle Scholar
  23. 23.
    Greisman SE, Hornick B (1969) Comparative reactivity of rabbit and man to bacterial endotoxin. Proc Soc Biol Med 131: 1154CrossRefGoogle Scholar
  24. 24.
    Dabbah R, Ferry E, Gunther DA (1980) Pyrogenicity of E. coli 055: B 5 endotoxin by the USP rabbit test — a HIMA colloborative study. J Parent Drug Assoc 34: 212Google Scholar
  25. 25.
    Parenteral Drug Association, Interindustry Communication (1980) A response to the Federal Register (Jan. 18,1980) 45: 3668Google Scholar
  26. 26.
    U.S. Food and Drug Administration (1980) Human and veterinary drugs; availability of draft guidelines for use of Limulus amebocyte lysate. Fed Reg 45: 3668Google Scholar
  27. 27.
    Tominaga H, Tanaka S, Tominaga N (to be published) Endotoxin level of sterile injection solutions and substitution fluid for haemofiltration in Japan and Australia. NephronGoogle Scholar
  28. 28.
    Elin RJ, Wolff SM (1973) Bacterial endotoxins. In: Laskin AP, Lechevalier P (eds) CRC Handbook on microbiology, vol II. CRC Press Cleveland, pp 215–239Google Scholar
  29. 29.
    Nolan JP, McDevitt JJ, Goldman GS (1975) Endotoxin binding by charged and uncharged resins. Proc Soc Exp Biol 149: 766–770PubMedCrossRefGoogle Scholar
  30. 30.
    Kaden H (1975) The use of asbestos filter beds in the production of sterile and pyrogen-free solutions. Pharmazie 29: 752–753Google Scholar
  31. 31.
    Koppensteiner G, Kruger D, Osmers K, Woog H, Zimmermann G (1976) An experimental investigation of the elimination of pyrogens from parenteral medicines. Drugs Made Ger 19: 113–123Google Scholar
  32. 32.
    Hannecart-Pokorny E, Dekegel D, Dupuydt F (1973) Macromolecular structure of lipopolysaccharides from gram-negative bacteria. Eur J Biochem 38: 6–13CrossRefGoogle Scholar
  33. 33.
    Ribi E, Anacker RL, Brown R, Haskins WT, Malmgren B, Milner KC, Rudback JS (1966) Reaction of endotoxin and surfactants in physical and biological properties of endotoxin treated with sodium deoxycholate. J Bacterid 92: 1493–1509Google Scholar
  34. 34.
    Rogers SW, Gilleland HE jr, Eagon RG (1969) Characterization of a protein lipopolysaccharide complex released from cell walls of Pseudomonas aeruginosa by ethylendiamintetraacetic acid. Can J Microbiol 15: 743–748PubMedCrossRefGoogle Scholar
  35. 35.
    Rudback JA, Milner KC (1968) Reaction of endotoxin and surfactants III. Effect of sodium lauryl sulfate on the structure and pyrogenicity of endotoxin. Can J Microbiol 14: 1173–1178CrossRefGoogle Scholar
  36. 36.
    Sweadner KJ, Forte M, Nelsen LL (1977) Filtration removal of endotoxin (pyrogens) in solution in different states of aggregation. Appl Exp Microbiol 34: 382–385Google Scholar
  37. 37.
    Zimmermann G, Kruger D, Woog H (1976) Pyrogen elimination from parenteral medicines by means of molecular filtration. Drugs Made Ger 19: 123–128Google Scholar
  38. 38.
    Nelsen LL (1978) Removal of pyrogens from parenteral solutions by ultrafiltration. Pharm Tech May: 47–50Google Scholar
  39. 39.
    Dinarello CA, Shaldon S (1985) Pyrogen removal my membrane filtration. Blood Purification (in press)Google Scholar
  40. 40.
    Henderson LW, Besarab A, Michaels A, Bluemle LW jr (1967) Blood purification by ultrafiltration and fluid replacement (diafiltration). Trans Am Soc Artif Intern Org 13: 216Google Scholar
  41. 41.
    Quellhorst E, Rieger J, Doht B, Beckmann H, Jakob J, Kraft B, Scheler F (1976) Treatment of chronic uremia by an ultrafiltration kidney. First clinical experience. Proc Eur Dial Transplant Assoc 13: 314–321Google Scholar
  42. 42.
    Hamilton R, Ford C, Colton C, Cross R, Steinmüller S, Henderson LW (1971) Blood cleaning by diafiltration in uremic dogs and man. Trans Am Soc Artif Intern Org 17: 259Google Scholar
  43. 43.
    Quellhorst E, Fernandez E, Scheler F (1972) Treatment of uremia using an ultrafiltration-filtration unit. Proc Eur Dial Transplant Assoc 9: 584PubMedGoogle Scholar
  44. 44.
    Henderson LW (1982) The beginning of hemofiltration. Contrib Nephrol 32: 1–19PubMedGoogle Scholar
  45. 45.
    Ramperez D, Beau MG, Deschodt G, Flavier JL, Nielsson L, Mion C, Shaldon S (1981) Economic preparation of sterile pyrogen-free infusate for hemofiltration. Proc Eur Dial Transplant Assoc 18: 293–296PubMedGoogle Scholar
  46. 46.
    Keshaviah P, Luehmann D (to be published) The importance of water treatment in haemodialysis and haemofiltrationGoogle Scholar
  47. 47.
    Daul A, Graben N, Bock KD (1981) Septicaemie als Komplikation der Haemofiltration. Diagn Intensivther 6: 284–294Google Scholar
  48. 48.
    Herrath D v, Schaefer K, Huefler M, Pauls A, Koch KM (1982) Complications of Hemofiltration. Contrib Nephrol 32: 146–153Google Scholar
  49. 49.
    Herrath D v, Schaefer K, Huefler M, Pauls A, Koch KM, Goehl H, Ljuggren L, Gardiner P (1983) Complications of hemofiltration. Int J Artif Organs 6: 49–52Google Scholar
  50. 50.
    Pearson FC, Weary ME, Bohon J, Dabbah R (1982) Relative potency of “environmental” endotoxin as measured by the Limulus amebocyte lysate test and the USP rabbit pyrogen test. In: Watson SW, Levin J, Novitsky TJ (eds) Endotoxins and their detection with the Limulus ame-bocyte lysate test. Riss, New York, pp 65–77Google Scholar
  51. 51.
    Pearson FC, Bohon J, Lee W, Bruszer G, Sagona M, Dawe R, Jakubowski G, Morrison D, Dinarello C (1984) Comparison of chemical analyses of hollow-fiber dialyzer extracts. Art Org 8: 291–298CrossRefGoogle Scholar
  52. 52.
    Henne W, Schulze H, Pelger W, Tretzel J, Sengbusch G v (1984) Hollow-fiber dialyzers and their pyrogenicity by Limulus amebocyte lysate. Artif Organs 8: 299–305PubMedCrossRefGoogle Scholar
  53. 53.
    Pearson FC (1983) The preparation of hemofiltration solution and quality assurance issues. 1st annual meeting International Society of Hemofiltration, Frankfurt, 1983Google Scholar
  54. 54.
    FDA (1983) Draft guideline for validation of the limulus amebocyte lysate test as an endproduct endotoxin test for human and parenteral drugs, biological products and medical devices. Pharmacopeial Forum 9: 3012–3021Google Scholar
  55. 55.
    Henderson LW, Dinarello CA, Koch KM, Shaldon S (1983) Interleukin 1 hypothesis. Blood Purification 1: 1CrossRefGoogle Scholar
  56. 56.
    Mayr HU, Stec F, Canaud B, Mion CM, Shaldon S (to be published) Microbiological aspects of the batch preparation of replacement fluid for hemofiltration. Blood PurificationGoogle Scholar
  57. 57.
    Henderson LW, Beans F (1978) Successful production of sterile pyrogenfree electrolyte solution by ultrafiltration. Kidney Int 14: 522–525PubMedCrossRefGoogle Scholar
  58. 58.
    Henderson LW, Sanfelippo ML, Beans E (1978) “On-line” preparation of sterile pyrogen-free electrolyte solution. Trans Am Soc Artif Intern Organs 24: 465–467PubMedGoogle Scholar
  59. 59.
    Henderson LW (1980) Hemofiltration for the treatment of hypertensions associ associated with end-stage renal failure. Artif Organs 4: 103–107PubMedCrossRefGoogle Scholar
  60. 60.
    Shaldon S, Beau MC, Deschodt G, Flavier JL, Ramperez P, Nielsson L, Mion C (1982) Three years of experience with on-line preparation of sterile pyrogen-free infúsate for hemofiltration. Contrib Nephrol 32: 161–164PubMedGoogle Scholar
  61. 61.
    Shaldon S, Beau MC, Branger B, Deschodt G, Delisle Nichols HF, Oules R, Ramperez P, Mion C (1983) Economic preparation of sterile non-pyrogenic infúsate for hemofiltration. Dialysis Transplantation 12: 792–793Google Scholar
  62. 62.
    Shaldon S, Beau MC, Deschodt G, Flavier JL, Nielsson L, Ramperez P, Mion C (1983) Three years of experience with on-line preparation of sterile pyrogen-free infúsate for hemofiltration. Intern J Artif Organs 6: 25–26Google Scholar
  63. 63.
    Hildebrand U, Quellhorst E (1983) Central proportioning system for the production of substitution fluid. Oral presentation at the International Workshop of Hemofiltration, Frankfurt, 1983Google Scholar
  64. 64.
    Haas T, Villeboeuf F, Fournier JF, Mayrand B, DeViel E, Dongradi G (1984) The extemporaneous preparation of sterile, pyrogen-free reinjection fluid for hemofiltration. Dial Transplant 13: 559–562Google Scholar
  65. 65.
    Yamagami S, Kishimoto T, Tanaka H, Mackawa M (1982) On-line preparation of substitution fluid for hemofiltration ( Abstr ). Eur Dialysis Transplant Assoc abstr 19: 154Google Scholar
  66. 66.
    Pierides AM, Schniepp B, Johnson WJ (1981) Two year experience with over 500 sessions of postdilution hemofiltration. Trans Am Soc Artif Intern Organs 17: 618–622Google Scholar
  67. 67.
    Eisenbach GM (1984) Hemofiltration substitution fluid preparation: Past, present and some future aspects. 2nd Annual workshop of the International Society of Hemofiltration, MilanGoogle Scholar
  68. 68.
    Keshaviah P, Ebben J, Hirsch D, Luehmann D, Collins A, Shapiro F (1983) On-site preparation of substitution fluid for large scale delivery of hemofiltration (HF) (Abstr). Am Soc Nephrol annual meeting, p 49 AGoogle Scholar
  69. 69.
    Keshaviah P, Luehmann D, Hirsch J, Ebben J, Collins A, Shapiro F (1984) Central on-site preparation of substitution fluid for hemofiltration (Abstr). Am Soc Artif Intern Organs, 30th annual meeting 13: 46Google Scholar
  70. 70.
    Luehmann D, Hirsch D, Ebben J, Collins A, Shapiro F, Keshaviah P (1984) Central on-site preparation of substitution fluid for hemofiltration. Trans Am Soc Artif Intern Organs 30: 195–198PubMedGoogle Scholar
  71. 71.
    Shaldon S, Deschodt G, Branger B, Oules R, Gullberg CA, Mion C (1983) Experience with online haemofiltration ( Abstr ). Artif Organs 7: 57Google Scholar
  72. 72.
    Shaldon S, Beau BC, Mayr H, Gullberg CA (1984) In-line hemofiltration. Am Soc Artif Intern Organs, 30th annual meeting, 13: 55Google Scholar
  73. 73.
    Shaldon S, Beau BC, Mayr H, Gullberg CA (1984) In-line hemofiltration. Int Soc Nephrol, 9th int congress, Los Angeles, p 189 AGoogle Scholar
  74. 74.
    Shaldon S, Deschodt G, Granolleras C, Oules R, Gullberg CA, Mayr H (to be published) Experience with on-line hemofiltration. Artif OrgansGoogle Scholar
  75. 75.
    Fuchs C, Quellhorst E, Scheler F (1984) Prophylaxis and methods for early recognition of aluminium intoxication. Contrib Nephrol 38: 81–91PubMedGoogle Scholar
  76. 76.
    Salvadeo H, Minoia C, Segagni S, Villa G (1979) Trace metal changes in dialysis fluid and blood of patients on hemodialysis. Intern J Artif Organs 2: 17–21Google Scholar
  77. 77.
    Sancipriano GP, Fidelio T, Squiccimarro G, Ragni R (1983) Aluminium (Al) in bags for HF: critical limits. International workshop on hemofiltration, Frankfurt, 1983Google Scholar
  78. 78.
    Mason JC, Jones NF, Hilton PJ (1983) Aluminium in hemofiltration solutions. Lancet 1: 762–763PubMedCrossRefGoogle Scholar
  79. 79.
    Cumming AD, Simpson G, Bell D, Cowie J, Winney RJ (1982) Acute aluminium intoxication in patients on continous ambulatory peritoneal dialysis. Lancet 1: 103–104PubMedCrossRefGoogle Scholar
  80. 80.
    Herrath D v, Schaefer K, Hüfler M, Gawlik D, Gardiner PE (1983) Spurenelemente im off-line hergestellten Infusat für die Hämofiltration. Nieren- Hochdruckkr 12: 175–178Google Scholar
  81. 81.
    Fuchs C, Quellhorst E, Scheler F (1983) Einfluß verschiedener Behandlungsverfahren auf die Plasma-Aluminiumkonzentration bei chronisch niereninsuffizienten Patienten. Nieren Hoch-druckkr 12: 179–185Google Scholar
  82. 82.
    Klinkmann H, Falkenhagen D, Smollich BP (to be published) Investigation of the permeability of highly permeable polysulfone membranes for pyrogen. Contrib NephrolGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1986

Authors and Affiliations

  • G. M. Eisenbach
  • S. Shaldon

There are no affiliations available

Personalised recommendations