Sterile low bicarbonate dialysis concentrate solutions

Abstract

The present invention relates to a sterile calcium-free low bicarbonate dialysis concentrate composition for use in conjunction with regional citrate anti-coagulation in the context of either dialysis or hemofiltration. Methods of use of the sterile calcium free low bicarbonate dialysis concentrate compositions are also disclosed. The low bicarbonate concentrate takes into account the fact that citrate is hepatically metabolized into bicarbonate, thus minimizing metabolic complications.

1 . A sterile dialysis concentrate composition for use in a dialysis solution comprising sodium chloride (NaCl) 90.72±9.0 g/l, magnesium chloride (MgCl2) 0.96±0.9 g/l, and sodium bicarbonate (NaHCO3) 28.35±2.8 g/l.  
   
   
       2 . A kit for preparing a dialysis solution comprising the sterile dialysis concentrate composition of  claim 1  and optionally instructions for its use.  
   
   
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       13 . A sterile calcium free low bicarbonate dialysis concentrate composition comprising sodium chloride (NaCl), magnesium chloride (MgCl2), and a concentration of sodium bicarbonate (NaHCO3) sufficiently low so as to allow preparation of a sterile calcium free dialysis solution for continuous renal replacement therapy comprising sodium chloride (NaCl), magnesium chloride (MgCl2) and an effective bicarbonate concentration between 20-30 mmol/l.  
   
   
       14 . A kit for preparing a dialysis solution comprising the sterile dialysis concentrate composition of  claim 13  and optionally instructions for its use.  
   
   
       15 . The kit of  claim 14  further comprising sterile water sufficient to dilute the concentrate to a solution comprising Na, Mg, Cl, and HCO3 25.0±2.5 mmol/l.  
   
   
       16 . A method of preparing a sterile dialysis solution comprising diluting a sterile, dialysis concentrate composition of  claim 13  in a sufficient amount of sterile water to prepare a dialysis solution comprising Na, Mg, Cl, and HCO3 25.0±2.5 mmol/l.  
   
   
       17 . A method for providing continuous renal replacement therapy to a patient comprising administering a sterile dialysis solution prepared according to the method of  claim 16  in conjunction with a regional citrate anti-coagulant solution to a patient in need thereof.  
   
   
       18 . A method of preparing a sterile dialysis solution or infusate comprising diluting a sterile, dialysis concentrate composition of  claim 13  in a sufficient amount of sterile water to prepare an infusate comprising Na, Mg, Cl, and HCO3 25.0±2.5 mmol/l.  
   
   
       19 . A method for treating acute renal failure in a critically ill patient without introducing calcium into the blood removed from the patient during dialysis comprising administering a sterile dialysis solution prepared according to the method of  claim 18  in conjunction with a regional citrate anti-coagulant solution to a patient in need thereof.  
   
   
       20 . A method for providing hemofiltration to a patient comprising administering a sterile infusate prepared according to the method of  claim 18  in conjunction with a regional citrate anti-coagulant solution to a patient in need thereof.  
   
   
       21 . A sterile dialysis solution comprising the concentrate as claimed in  claim 13  and a physiologically acceptable diluent.  
   
   
       22 . The sterile dialysis solution according to  claim 21  comprising Na, Mg, Cl, and HCO3 25.0±2.5 mmol/l.  
   
   
       23 . A method of preparation of a sterile calcium-free bicarbonate concentrate according to  claim 13  as an infusate for hemofiltration.  
   
   
       24 . A method of preparation of a sterile, calcium free bicarbonate concentrate according to  claim 13  as a dialysis solution for use in metabolic acidosis.  
   
   
       25 . A method for correcting bicarbonate levels in a patient during dialysis comprising providing a dialysate mixture having a bicarbonate level sufficiently low so as to minimize the risk of metabolic complication in the patient between 20-30 mmol/litre, wherein should the patient's bicarbonate level drop below the preferred level, bicarbonate diffuses from the dialysate across the semipermable membrane to the patient to correct the problem, and wherein if there is an excess of bicarbonate in the blood of the patient then bicarbonate diffuses from the blood to the dialysate to correct the problem.  
   
   
       26 . A sterile calcium free low bicarbonate concentrate containing magnesium chloride, sodium chloride, and a concentration of bicarbonate sufficiently low so as to allow preparation of a sterile calcium free dialysis solution for continuous renal replacement therapies such as dialysis and hemofiltration, wherein the effective bicarbonate level in the resulting dialysis solution is between 20-30 mmol/litre to minimize the risk of metabolic complications in a patient.  
   
   
       27 . A method for treating acute renal failure in a critically ill patient comprising dialyzing blood from the patient, without introducing calcium into the blood removed from the patient during dialysis, by using a sterile dialysis solution having a bicarbonate concentration between 20-30 mmol/litre.  
   
   
       28 . The method of  claim 27  wherein the dialysis solution further comprises at least one of potassium, glucose, and ketones such as b hydroxy-butyrate.  
   
   
       29 . A sterile calcium free dialysis concentrate, for use in the preparation of a dialysis solution for continuous renal replacement therapy, and having a bicarbonate level sufficiently low so as to minimize the risk of metabolic complications in a patient and comprising sodium chloride, magnesium chloride, and sodium bicarbonate at an effective concentration in the dialysis solution between 20-30 mmol/litre.  
   
   
       30 . A calcium free low bicarbonate sterile dialysis concentrate composition for use in the preparation of a sterile dialysis solution for continuous renal replacement therapy comprising sodium chloride, magnesium chloride and a concentration of sodium bicarbonate (NaHCO 3 ) sufficiently low so as to allow