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.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a sterile concentrate dialysis solution. More particularly, it relates to a sterile calcium-free low bicarbonate concentrate solution for use in dialysis and hemofiltration. BACKGROUND OF THE INVENTION [0002] The purification of blood and separation of fluids using dialysis can be advantageously used in many medical applications, particularly conditions where renal function has significantly declined. Dialysis removes wastes from blood through a semipermeable membrane by diffusive or convective processes. There are two principal dialysis methods used to support patients requiring renal replacement therapy: hemodialysis and peritoneal dialysis [0003] Hemodialysis, involves the removal of solutes and fluids (such as urea, creatinine and uric acid) from the blood through a dialysis membrane by diffusion into a dialysate. The dialysis membrane is a semipermeable membrane which is typically made of cellulose. Blood solutes co...

AI Technical Summary

Benefits of technology

[0023] This invention generally relates to concentrates and corresponding diluted dialysis solutions with reduced bicarbonate concentrations and methods and uses therefor. CRRT requires the addition of an anti-coagulent such as citrate to either the dialysate or directly infused into the blood entering the extracorporeal circuit to prevent thrombosis. Citrate is an organic acid which is hepatically metabolized to bicarbonate. Research has shown that patients differ in their sensitivity to bicarbonate in the dialysate. For instance, in some patients excessive bicarbonate may result in alkalemia, whereas, in some patients insufficient bicarbonate may result in acidemia. Therefore, if citrate is used as the anti-coagulent, then it is important that the concentration of bicarbonate in the dialysate be relatively low, depending on the sensitivity of the individual patient. Usage of a low bicarbonate dialysate solution of the invention takes into account the bicarbonate derived from citrate, and as a result the total effective bicarbonate concentration is accounted for and effectively controlled. Thus, metabolic complications are effectively minimized. The low bicarbonate sterile solution of the invention typically contains a bicarbonate concentration within the range of 5-30 mmol / l, preferably between 20-30 mmol / l, and more preferably 25±2.5 mmol / l. The solutions with bicarbonate concentrations below 25 mmol / L may have sodium citrate added to them up to 20 mmol / L to act as an anticoagulant.

[0029] The concentrates offer a convenient means to prepare sterile and pyrogen free solutions at the bedside or in the pharmacy to avoid extemporaneous mixing. The low bicarbonate concentrate of the first embodiment of the invention may be provided as a sterile concentrate in unit dosage to be added to a fixed volume of sterile water in PVC bags or as a prediluted sterile solution containing Na 140±14 mmol / l, Mg 0.75±0.07 mmol / l, Cl 116.5±11 mmol / l, and HCO3 25.0±2.5 mmol / l. The concentrate and the dilute solution contained in glass or CO2 impermeable plastic bags are stable and able to be stored for prolonged periods (up to 2 years). The storage must be at temperatures from 10° C. to 40° C.

Problems solved by technology

For instance, in some patients excessive bicarbonate may result in alkalemia, whereas, in some patients insufficient bicarbonate may result in acidemia.