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WO1993014796A1 - Composition de dialyse peritoneale et procede pouvant etre utilise pendant ou apres la peritonite - Google Patents

Composition de dialyse peritoneale et procede pouvant etre utilise pendant ou apres la peritonite Download PDF

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Publication number
WO1993014796A1
WO1993014796A1 PCT/US1992/000972 US9200972W WO9314796A1 WO 1993014796 A1 WO1993014796 A1 WO 1993014796A1 US 9200972 W US9200972 W US 9200972W WO 9314796 A1 WO9314796 A1 WO 9314796A1
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WO
WIPO (PCT)
Prior art keywords
peritoneal
solution
patient
peritonitis
amino acids
Prior art date
Application number
PCT/US1992/000972
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English (en)
Inventor
Andrzej Breborowicz
Dimitrios G. Oreopoulos
Gerald H. Anderson
Original Assignee
Baxter International, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International, Inc. filed Critical Baxter International, Inc.
Priority to CA002102234A priority Critical patent/CA2102234C/fr
Priority to PCT/US1992/000972 priority patent/WO1993014796A1/fr
Publication of WO1993014796A1 publication Critical patent/WO1993014796A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/446—Superoxide dismutase (1.15)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/287—Dialysates therefor

Definitions

  • Peritoneal dialysis composition and method usable during and after peritonitis are disclosed.
  • the invention generally relates to peritone- al dialysis solutions, especially those used in the practice of continuous ambulatory peritoneal dialysis, or CAPD.
  • Peritoneal dialysis periodically infuses sterile aqueous solution into the peritoneal cavity. Diffusion exchange takes place between the solution and the bloodstream across the natural body membranes. The diffusion removes the waste products that the kid ⁇ neys normally excrete. The waste products typically consist of solutes like sodium and chloride ions, and the other compounds normally excreted through the kid ⁇ neys like as urea, creatinine, and water. The diffu ⁇ sion of water across the peritoneal membrane during dialysis is called ultrafiltration.
  • the inflammation of the peritoneum, called peritonitis is an undesired complication of peritoneal dialysis. The inflammation may lead to loss of mesothelial cells and the excessive growth of fibrous connective tissue in the peritoneum membrane, called fibrosis. These reactions can lead to the loss of ultrafiltration during dialysis.
  • peritonitis may lead to in ⁇ creased protein loss in the patient, with the patient not feeling well enough to eat to replace this loss.
  • peritoneal dialysis patients experiencing peritonitis often receive hypertonic dialysis solutions, typically containing glucose as an osmotic solute.
  • hypertonic solu- tions for these purposes may be counterproductive. Due to their low pH, high osmolarity, and the presence of glucose, the solutions may inhibit the necessary regeneration of mesothelial cells. They also may lead to the growth of fibroblasts, causing fibrosis.
  • conventional dialysis solutions also may include mix ⁇ tures of nutritionally essential amino acids (like methionine, tryptophan, and isoleucine) and nutrition- ally non-essential amino acids (like glycine and ala- nine) .
  • nutritionally essential amino acids like methionine, tryptophan, and isoleucine
  • nutrition- ally non-essential amino acids like glycine and ala- nine
  • peritoneal dialysis solutions that can be used during and immedi ⁇ ately • after peritonitis without potentially counterproductive effects.
  • the solutions would promote the replacement of mesothelial cells, minimize the formation of fibroblasts, and counter the atten- dant loss of ultrafiltration that peritonitis often causes .
  • the invention provides improved peritoneal dialysis solutions that can be used during and after episodes of peritonitis to protect the patient against the inflammatory reactions of peritonitis, fibrosis, and the loss of ultrafiltration.
  • the invention also provides improved peritoneal dialysis solutions that can be used after episodes of peritonitis to at least partially restore ultrafiltration characteristics lost due to peritonitis.
  • One aspect of the invention provides perito ⁇ neal dialysis solutions that maintain a positive ni ⁇ trogen balance during peritonitis without significant- ly inhibiting the proliferation of mesothelial cells.
  • This aspect of the invention replaces at least some individual amino acids in the dialysis solution with amino acids in their dipeptide form.
  • amino acids stunt the proliferation of mesothelial cells. By using these amino acids in their dipeptide form instead, significant improvements in the proliferation of mesothelial cells occur.
  • at least some amino acids like methionine, tryptophan, or isoleucine appear in their dipeptide form (for example, glycine-tryptophan) to achieve this beneficial effect.
  • peritoneal dialysis solu ⁇ tion of amino acids in dipeptide form with other es- sential and non-essential amino acids enhances the anabolic state of the patient suffering peritonitis.
  • the solution does not unduly inhibit the regeneration of mesothelial cells that is necessary to the patient's healing process.
  • Another aspect of the invention supplements peritoneal dialysis solution with compounds that act as scavengers of free radicals present within the peritoneal cavity. The inventors have discovered that the free radicals released by peritoneal cells during peritonitis can injure mesothelial and endothelial cells and may otherwise case disfunction of the peri ⁇ toneal membrane.
  • the scavengers are vitamin E, procysteine, superoxide dismutase, or chondroitin sul ⁇ fate.
  • chondroitin sulfate also beneficially changes the permeability of the peritoneal membrane during subsequent dialysis using conventional solutions. Chondroitin sulfate enhances the subsequent ultrafiltration characteristics of the peritoneal membrane using conventional dialysis solu ⁇ tion. It also decreases the absorption of glucose and transperitoneal loss of proteins with no change in urea diffusion.
  • Chondroitin sulfate therefore serves not only as a free radical scavenger to minimize cel- lular injury caused by inflammation during peritoni ⁇ tis, but it can be used after an episode of peritoni ⁇ tis to at least partially restore loss of ultrafiltra ⁇ tion characteristics caused by peritonitis.
  • Another aspect of the invention includes the degradation products of hyaluronic acid as an additive to a peritoneal dialysis solution to enhance the re ⁇ generation of the peritoneal mesothelium without fi ⁇ brosis.
  • the inventors believe that these degradation products, principally oligosaccarides, will increase the proliferation of endothelial cells without affect- ing fibroblasts growth.
  • additive compounds used alone or in combination in peritoneal dialysis solutions, can en ⁇ hance the regeneration of mesothelial cells and pre- vent the growth of fibroblasts. They can improve the nutritional status of the patient during peritonitis. They can actively decrease the degree of damage occur ⁇ ring during inflammation of the peritoneal membrane. They can restore the peritoneal membrane to its pre- peritonitis condition.
  • Fig. 1 is a chart showing the mean value in ° 6 Rb uptake by human mesothelial cells (HMC) through different pathways after being cultured for 7 days in medium with high concentrations (90 mM) of glucose, glycerol, and mannitol, expressed as a % of control where the HMC were cultured in normotonic medium; and
  • Fig. 2 is a graph showing the accumulation of ° 6 Rb during 72 hours in HMC exposed to different high glucose concentrations, expressed as a % of con- trol where the HMC were cultured in normotonic medium.
  • the CAPD patient After an episode of peritonitis, the CAPD patient typically receives a hypertonic peritoneal dialysis solution containing glucose. The intent is to counteract the loss of ultrafiltration that fre- quently occurs during peritonitis.
  • HMC human mesothelial cells
  • the inventors have also experimentally determined that about 60% of ° * 'Rb transport occurs through active Channel (l), the Na-K-ATPase pump; about 29% through active Channel (2) ; and about 11% through passive Channel (3).
  • HMC HMC were isolated from omentum following the method described in Van Bronswwijk et al. , "Cytotoxic Effects of Commercial Continuous Ambulatory Peritoneal Dialysis (CAPD) Fluids and of Bacterial Exoproducts on Human Mesothelial Cells in Vitro," Perit Dial Intern, 1989 (9) : 197-202.
  • the HMC were seeded into 75. c ⁇ r culture flasks and grown to confluency. Then, the HMC were harvested with trypsin-EDTA solution and seeded into 96-well culture plates and there again grown to confluency. The study used the confluent mesothelial monolayers cultured in the 96-well plates.
  • HMC HMC were incubated in the culture medium for 7 days with various osmotic solutions (90 mM and more of glucose or glycerol or mannitol) . After incuba ⁇ tion, potassium analog °°Rb was added to the medium. The uptake of °°Rb by HMC was measured and compared with the uptake in control HMC not. exposed to osmotic solutes (the control HMC having been cultured in a normotonic medium) .
  • Fig. 2 shows, the intracellular accumula ⁇ tion of 86 Rb in HMC exposed for 72 hours to increased concentrations of glucose diminished proportionally to the glucose concentration, compared to the accumula ⁇ tion in the control HMC.
  • HMC potassium loss both through diminished active influx, mostly by reduced Na-K-ATPase activity, and through an outflux of ion-rich water ("wash-out") from the cells due to a negative osmotic gradient. Also see Moreno et al. , "Increase in Serum Potassium Resulting from the Admin ⁇ istration of Hypertonic Mannitol and Other Solutions," J Lab Clin Med 1969; 73: 291-294.
  • the presence of these disfunctions does not promote the regeneration of mesothelial cells necessary to the healing process during and after a peritonitis episode.
  • the peritoneal dialysis solutions that em ⁇ body the features of the invention are specially for ⁇ mulated for patients for use during and immediately after episodes of peritonitis.
  • the solutions promote the healing process to avoid or at least minimize the injury and adverse physiological effects of peritoni ⁇ tis upon the dialysis regime of the patient.
  • the solutions that embody the features of the invention include: (1) physiological salts such as sodium chloride, calcium chloride and sodium acetate in ap ⁇ intestinalte concentrations to maintain a normal electro ⁇ lyte profile. Typical concentrations are from 116 to 140 mEq/liter of sodium; 0 to 6 mEq/liter of calcium, and 100 to 144 mEq/liter of chloride.
  • lactate or bicarbonate in appropri ⁇ ate concentrations to maintain a physiologically tol ⁇ erable pH of between about 5 to about 7.4. Typical concentrations are from 30 to 45 mEq/liter of lactate;
  • the solutions contain one or more of the following additives:
  • a preferred embodiment of the amino acid additive (4) comprises, based on one liter of solution, about 0.1 to 10 mM each of the nutritionally essential amino acids methionine, tryptophan, isoleucine, valine, leucine, lysine, histidine, threo ⁇ nine, and phenylalanine, at least some of which are present in their dipeptide form. When present as dipeptides, these amino acids do not inhibit mesothelial cell proliferation as much as they do when present as individual amino acids.
  • the most preferred embodiment includes at least tryptophan in its dipeptide form (glycine-tryp- tophan, or gly-trp) , as the individual amino acid tryptophan inhibits mesothelial cell proliferation more than an other individual amino acid.
  • glycine-tryp- tophan or gly-trp
  • the mixture also includes about 0.1 to 10 m each of arginine, alanine, proline, glycine, serine, tyrosine, cysteine (cystine) , and other individual, nutritionally non-essential amino acids as required to maintain a positive nitrogen balance in the patient.
  • Example illustrates the benefits of using amino acids in a dialysis solution, of which certain are in their dipeptide form.
  • EXAMPLE 2 This study evaluated the toxicity of. a mix ⁇ ture of essential and non-essential amino acids on the proliferation of HMC in conditions simulating perito ⁇ neal dialysis.
  • HMC prepared as described in Example 1 were exposed to essential and nonessential amino acids. Adverse effects were measured in terms of the impact upon cell proliferation (as measured by incorporation of 3H-thymidine) and the release of LDH from cell cy ⁇ toplasm.
  • HMC When HMC are exposed to tryptophan in a con ⁇ centration of 5 M for.24 hours, their proliferation is reduced by 82%, compared to the proliferation of control HMC cells not exposed to tryptophan. After 24 hours of exposure, tryptophan (5 mM) also increased the leakage of LDH from the mesothelial monolayer HMC by 740%, compared to the control HMC cells.
  • the inclusion of the dipep ⁇ tide form of the amino acid in the mixture reduced the undesired effect by about 50%.
  • Peritonitis activates peritonealmacrophages (as proved by others) .
  • the activation of the macrophages leads to the increased generation of free radicals.
  • the inventors believe that the increased generation of free radicals causes peritoneal peroxidation.
  • the use of compounds that scavenge free radicals in peritoneal dialysis solutions minimizes or alleviates peritoneal peroxidation during episodes of peritonitis.
  • the inventors have also shown that the increased presence of free radicals also injures meso- thelial cells in the peritoneum.
  • the free radicals probably also injure endothelial cells, too.
  • the free radicals can depolymerize hyaluronic acid and/or col ⁇ lagen in interstitium, causing disfunction of the peritoneal membrane.
  • these undesired effects of peritonitis also can be minimized or lessened by supplementing the dialysis solution with free radical scavengers.
  • rats infused with the vitamin E-sup- ple ented saline the concentration of malondialdehyde in the omentum (and therefore the severity of perito ⁇ neal peroxidation) was lower (4.53+/-0.30 uM/100 ug tissue) than in the rats infused with saline alone (9.38+/-0.90 uM/100 ug tissue).
  • the xanthine-xanthine oxidase system was added to dialysis solution (2.5% dextrose) .
  • the solution was infused into the peritoneal cavities of rats.
  • the increased presence of the free radicals generated by the infused oxidase system caused loss of ultrafiltration and increased glucose absorption, the same physiological effects observed during episodes of peritonitis.
  • This result further links the increased presence of free radicals to the inflammatory effects and injury of peritonitis.
  • the addition of free radical scavenger vita ⁇ min E (0.01%) reduced or totally reversed the adverse effects caused by the free radicals generated by the xanthine-xanthine oxidase system.
  • the free radical scavenger would have the same beneficial effect in the increased presence of the free radicals during perito ⁇ nitis.
  • the scavengers are selected from the group consisting of vitamin E, procysteine, superoxide dis utase, and chondroitin sulfate and are present in concentrations of about 0.01 to 0.5 g%.
  • the perito ⁇ neal dialysis solution includes chondroitin sulphate to change or restore transperitoneal transport after an episode of peritonitis.
  • EXAMPLE 4 Saline supplemented with chondroitin sul ⁇ phate (0.1 g%) was infused into the peritoneal cavity of rats over a period of six days. Then, conventional 2.5% Dianeal peritoneal dialysis solution (sold by Baxter Healthcare Corporation, Deerfield, Illinois) was infused into the peritoneal cavities of the rats. The chronic exposure to the chondroitin sul- phate modified the permeability of the peritoneal mem- brane during the subsequent dialysis with conventional dialysis solution. The net ultrafiltration measured after a dwell period of four hours was more than the ultrafiltration measured before exposure to the chondroitin sulphate.
  • This Example illustrates the benefits of using chondroitin sulphate in a dialysis solution to restore transperitoneal transport after an episode of peritonitis.
  • the chondroitin sulphate is present in a concentration of about 0.01 to 0.5 g .
  • peritoneal dialysis solution includes degradation products of hyaluronic acid to enhance the . regeneration of the peritoneal mesothelium without fibrosis.
  • the dialysis solutions containing one or more of the additives (4) to (7) when sterile, may be used as the peritoneal dialysis solution in a conven ⁇ tional CAPD procedure, using the techniques and equip ⁇ ment developed and sold by the Baxter Healthcare Cor- poration, Deerfield, Illinois.

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Abstract

Les solutions de dialyse péritonéale sont formulées spécifiquement pour être utilisées pendant et juste après une crise de péritonite. Ces solutions renfermant au moins un additif qui minimise le traumatisme et les effets physiologiques produits par la péritonite. Un de ces additifs est un mélange d'acides aminés qui suffit pour maintenir un bilan azoté positif, au mins un de ces acides aminés étant présent sous forme dipeptidique. Un autre additif est un composé qui épure les radicaux libres produits par les macrophages péritonéaux activés par la péritonite. Un autre additif est du chondroïtine sulfate qui modifie la perméabilité de la membrane péritonéale pendant la dialyse, à l'aide de solutions ne renfermant pas de congroïtine-sulfate. Un autre additif correspond aux produits de dégradation de l'acide hyaluronique et permet de stimuler la régénération du mésothélium péritonéal sans provoquer de fibrose.
PCT/US1992/000972 1992-02-04 1992-02-04 Composition de dialyse peritoneale et procede pouvant etre utilise pendant ou apres la peritonite WO1993014796A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA002102234A CA2102234C (fr) 1992-02-04 1992-02-04 Composition de dialyse peritoneale; methode applicable avant et apres la peritonite
PCT/US1992/000972 WO1993014796A1 (fr) 1992-02-04 1992-02-04 Composition de dialyse peritoneale et procede pouvant etre utilise pendant ou apres la peritonite

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CA002102234A CA2102234C (fr) 1992-02-04 1992-02-04 Composition de dialyse peritoneale; methode applicable avant et apres la peritonite
PCT/US1992/000972 WO1993014796A1 (fr) 1992-02-04 1992-02-04 Composition de dialyse peritoneale et procede pouvant etre utilise pendant ou apres la peritonite

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2407571A (en) * 2003-10-29 2005-05-04 Wivenhoe Technology Ltd Treatment of sugar solutions
EP2204387A1 (fr) * 2007-10-01 2010-07-07 Seikagaku Corporation Nouveau sulfate de chondroïtine à moindre masse moléculaire et son utilisation
RU2465810C1 (ru) * 2011-10-26 2012-11-10 Государственное учреждение здравоохранения Научно-исследовательский институт скорой помощи имени Н.В. Склифосовского Департамента здравоохранения г. Москвы Способ выбора хирургической тактики при перитоните на основании результатов диагностической видеолапароскопии
WO2013174863A1 (fr) 2012-05-23 2013-11-28 Altergon S.A. Chondroïtine destinée à être utilisée en médecine
RU2770281C1 (ru) * 2021-10-26 2022-04-15 Государственное бюджетное учреждение здравоохранения города Москвы «Научно-исследовательский институт скорой помощи им. Н.В. Склифосовского Департамента здравоохранения города Москвы» (ГБУЗ "НИИ СП ИМ. Н.В.СКЛИФОСОВСКОГО ДЗМ") Способ выбора тактики хирургического лечения при распространенном аппендикулярном перитоните

Citations (9)

* Cited by examiner, † Cited by third party
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US4339433A (en) * 1981-01-09 1982-07-13 Baxter Travenol Laboratories, Inc. Additives for peritoneal dialysis solutions
US4574085A (en) * 1981-05-15 1986-03-04 Baxter Travenol Laboratories, Inc. Method for using dialysis solution containing glycerol
US4761237A (en) * 1981-07-10 1988-08-02 Baxter Travenol Laboratories, Inc. Peritoneal dialysis solution containing carbohydrate polymers
US4828561A (en) * 1979-01-22 1989-05-09 Sterling Drug Inc. Bio compatible and blood compatible materials and methods
US4863907A (en) * 1984-06-29 1989-09-05 Seikagaku Kogyo Co., Ltd. Crosslinked glycosaminoglycans and their use
US4880629A (en) * 1985-04-25 1989-11-14 Terumo Kabushiki Kaisha Dialytic solution for peritoneal dialysis
US4886789A (en) * 1983-01-12 1989-12-12 M. L. Laboratories Plc Peritoneal dialysis and compositions for use therein
US4976683A (en) * 1986-06-20 1990-12-11 Abbott Laboratories Peritoneal dialysis method
US5039609A (en) * 1985-09-10 1991-08-13 Research Technologies, Inc. Osmotic agents for peritoneal dialysis

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4828561A (en) * 1979-01-22 1989-05-09 Sterling Drug Inc. Bio compatible and blood compatible materials and methods
US4339433A (en) * 1981-01-09 1982-07-13 Baxter Travenol Laboratories, Inc. Additives for peritoneal dialysis solutions
US4574085A (en) * 1981-05-15 1986-03-04 Baxter Travenol Laboratories, Inc. Method for using dialysis solution containing glycerol
US4761237A (en) * 1981-07-10 1988-08-02 Baxter Travenol Laboratories, Inc. Peritoneal dialysis solution containing carbohydrate polymers
US4886789A (en) * 1983-01-12 1989-12-12 M. L. Laboratories Plc Peritoneal dialysis and compositions for use therein
US4863907A (en) * 1984-06-29 1989-09-05 Seikagaku Kogyo Co., Ltd. Crosslinked glycosaminoglycans and their use
US4880629A (en) * 1985-04-25 1989-11-14 Terumo Kabushiki Kaisha Dialytic solution for peritoneal dialysis
US5039609A (en) * 1985-09-10 1991-08-13 Research Technologies, Inc. Osmotic agents for peritoneal dialysis
US4976683A (en) * 1986-06-20 1990-12-11 Abbott Laboratories Peritoneal dialysis method

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2407571A (en) * 2003-10-29 2005-05-04 Wivenhoe Technology Ltd Treatment of sugar solutions
EP2204387A1 (fr) * 2007-10-01 2010-07-07 Seikagaku Corporation Nouveau sulfate de chondroïtine à moindre masse moléculaire et son utilisation
EP2204387A4 (fr) * 2007-10-01 2011-08-24 Seikagaku Kogyo Co Ltd Nouveau sulfate de chondroïtine à moindre masse moléculaire et son utilisation
KR101480585B1 (ko) 2007-10-01 2015-01-08 세이가가쿠 고교 가부시키가이샤 신규 저분자화 콘드로이틴황산 및 그 용도
US9149572B2 (en) 2007-10-01 2015-10-06 Seikagaku Corporation Chondroitin sulfate having decreased molecular weight and use thereof
RU2465810C1 (ru) * 2011-10-26 2012-11-10 Государственное учреждение здравоохранения Научно-исследовательский институт скорой помощи имени Н.В. Склифосовского Департамента здравоохранения г. Москвы Способ выбора хирургической тактики при перитоните на основании результатов диагностической видеолапароскопии
WO2013174863A1 (fr) 2012-05-23 2013-11-28 Altergon S.A. Chondroïtine destinée à être utilisée en médecine
RU2770281C1 (ru) * 2021-10-26 2022-04-15 Государственное бюджетное учреждение здравоохранения города Москвы «Научно-исследовательский институт скорой помощи им. Н.В. Склифосовского Департамента здравоохранения города Москвы» (ГБУЗ "НИИ СП ИМ. Н.В.СКЛИФОСОВСКОГО ДЗМ") Способ выбора тактики хирургического лечения при распространенном аппендикулярном перитоните

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Publication number Publication date
CA2102234C (fr) 2008-11-18
CA2102234A1 (fr) 1993-08-05

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