Bicarbonate-based solutions for dialysis therapies

Abstract

Bicarbonate containing solutions for use during medical treatment are provided. The bicarbonate containing solution of the present invention includes at least two separate components including a bicarbonate concentrate and an electrolyte concentrate which can be readily and sterilely mixed to form a ready-to-use formulation for patient administration, particularly as applied to the treatment of acute renal failure associated with critically ill patients in an intensive care setting.

1 . A dialysis solution comprising: 
 a first part including a bicarbonate concentrate; and    a second part including an electrolyte concentrate at least including potassium, wherein a mixed solution of the first part and the second part includes about 5 mmol/L or less of potassium.    
   
   
       2 . The dialysis solution of  claim 1 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       3 . The dialysis solution of  claim 1 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       4 . The dialysis solution of  claim 1 , wherein the dialysis solution is selected from the group consisting of a hemodialysis solution, a continuous renal replacement therapy solution, an infusion solution, and a peritoneal dialysis solution.  
   
   
       5 . The dialysis solution of  claim 1 , wherein the dialysis solution does not include at least one of acetate and lactate.  
   
   
       6 . A dialysis solution comprising: 
 a first part including a bicarbonate concentrate; and    a second part including an electrolyte concentrate at least including potassium at about 11 mmol/L or less.    
   
   
       7 . The dialysis solution of  claim 6 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       8 . The dialysis solution of  claim 6 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       9 . The dialysis solution of  claim 6 , wherein the dialysis solution is selected from the group consisting of a hemodialysis solution, a continuous renal replacement therapy solution, an infusion solution, and a peritoneal dialysis solution.  
   
   
       10 . The dialysis solution of  claim 6 , wherein the dialysis solution does not include at least one of acetate and lactate.  
   
   
       11 . A dialysis solution comprising: 
 a first part including a bicarbonate concentrate;    a second part including an electrolyte concentrate; and    each of the bicarbonate concentrate and the electrolyte concentrate including a physiological acceptable amount of potassium.    
   
   
       12 . The dialysis solution of  claim 11 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       13 . The dialysis solution of  claim 11 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       14 . The dialysis solution of  claim 11 , wherein the dialysis solution is selected from the group consisting of a hemodialysis solution, a continuous renal replacement therapy solution, an infusion solution, and a peritoneal dialysis solution.  
   
   
       15 . The dialysis solution of  claim 11 , wherein the dialysis solution does not include at least one of acetate and lactate.  
   
   
       16 . A method of providing dialysis comprising: 
 providing a dialysis solution including a bicarbonate concentrate and an electrolyte concentrate, wherein the electrolyte concentrate at least includes potassium;    mixing the bicarbonate concentrate and the electrolyte concentrate to form a mixed solution including about 5 mmol/L or less of potassium; and    using the mixed solution during dialysis.    
   
   
       17 . The method of  claim 16 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       18 . The method of  claim 16 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       19 . The method of  claim 16 , wherein the dialysis solution is used during dialysis selected from the group consisting of hemodialysis, continuous renal replacement therapy, and peritoneal dialysis.  
   
   
       20 . The method of  claim 16 , wherein the dialysis solution is infused into the patient as an infusion solution.  
   
   
       21 . The method of  claim 16 , wherein the dialysis solution does not include at least one of acetate and lactate.  
   
   
       22 . A method of providing dialysis comprising: 
 providing a dialysis solution including a bicarbonate concentrate and an electrolyte concentrate, wherein the electrolyte concentrate at least includes potassium at about 11 mmol/L or less;    mixing the bicarbonate concentrate and the electrolyte concentrate to form a mixed solution; and    using the mixed solution during dialysis.    
   
   
       23 . The method of  claim 22 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       24 . The method of  claim 22 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       25 . The method of  claim 22 , wherein the dialysis solution is used during dialysis selected from the group consisting of hemodialysis, continuous renal replacement therapy solution, and peritoneal dialysis solution.  
   
   
       26 . The method of  claim 22 , wherein the dialysis solution is infused into the patient as an infusion solution.  
   
   
       27 . The method of  claim 22 , wherein the dialysis solution does not include at least one of acetate and lactate.  
   
   
       28 . A method of providing dialysis comprising: 
 providing a dialysis solution including a bicarbonate concentrate and an electrolyte concentrate, wherein the bicarbonate concentrate and the electrolyte concentrate each include a physiological amount of potassium;    mixing the bicarbonate concentrate and the electrolyte concentrate to form a mixed solution; and    using the mixed solution during dialysis.    
   
   
       29 . The method of  claim 28 , wherein the mixed solution further comprises about 100 mmol/L to about 173 mmol/L of sodium, about 0 mmol/L to about 2.0 mmol/L of calcium, about 0 mmol/L to about 1.5 mmol/L of magnesium, about 20 mmol/L to about 45 mmol/L of bicarbonate, about 70 mmol/L to about 130 mmol/L of chloride, about 0 mmol/L to about 45 mmol/L of lactate, about 0 mmol/L to about 45 mmol/L of acetate, about 0 g/L to about 2.5 g/L of anhydrous glucose, and about 0 g/L to about 1.1 g/L of hydrous dextrose.  
   
   
       30 . The method of  claim 28 , wherein the first part is stored in a first chamber of a multi-chamber container and the second part is stored in a second chamber of the multi-chamber container.  
   
   
       31 . The method of  claim 28 , wherein the dialysis solution is used during dialysis selected from the group consisting of hemodialysis, continuous renal replacement therapy solution, and peritoneal dialysis solution.  
   
   
       32 . The method of  claim 28 , wherein the dialysis solution is infused into the patient as an infusion solution.  
   
   
       33 . The method of  claim 28 , wherein the dialysis solution does not include at least one of acetate and lactate.