Albumin-based colloid composition and method of use in treating hypovolemia and multiorgan dysfunction

Abstract

A composition comprising an albumin-based colloid and its use in treating hypovolemic conditions such as capillary leak syndrome and shock are disclosed.

1 - 11 . (canceled) 
     
     
         12 . A method for the prevention of mammalian tissue injury resulting from at least one hypovolemic condition comprising the administration of a therapeutic amount of a composition comprising a PEGylated albumin-based colloid to a mammal at risk of such tissue injury. 
     
     
         13 . The method of  claim 12 , where the risk of tissue injury is due to sepsis, shock, burn, trauma, surgery, predisposition to capillary leak, hyperviscosity states, hypoalbuminemia, leukopheresis, nutritional albumin deficiency, nephritic syndrome, liver failure, and/or anorexia. 
     
     
         14 . The method of  claim 12 , in which the composition is used as a hyperosmotic agent driving ultrafiltration in peritoneal dialysis patients. 
     
     
         15 . A method for forming a PEGylated albumin-based colloid comprising modifying at least one albumin with at least one polyethylene oxide wherein the albumin is modified by using N-hydroxysuccinamide esters. 
     
     
         16 - 17 . (canceled) 
     
     
         18 . A method for forming a PEGylation product of albumin, comprising the steps of dissolving albumin in potassium phosphate to form form an albumin solution;
 activating methoxy polyethylene glycol with cyanuric chloride and dissolving in water to form a methoxy polyethylene glycol solution;   adding the methoxy polyethylene glycol solution to the albumin solution to form a mixture;   stirring the mixture for a suitable time at about room temperature;   dialyzing the mixture against a phosphate buffered saline solution at about 40° C. for a suitable time; and   collecting the resulting PEGylation product of albumin.   
     
     
         19 . The method of  claim 18 , in which the serum albumin is human albumin, bovine serum albumin, lactalbumin, recombinant albumin or ovalbumin. 
     
     
         20 . The method of  claim 18 , in which the ratio of a volume of the methoxy glycol solution to a volume of the albumin solution is in the range of about 1 to about 3. 
     
     
         21 - 23 . (canceled) 
     
     
         24 . The method of  claim 12  wherein the PEGylated albumin has a molecular excluded volume and a hydrodynamic radius sufficiently large to preclude the composition from leaking through a patient's capillaries. 
     
     
         25 - 33 . (canceled)