THERAPY PREDICTION AND OPTIMIZATION OF SERUM POTASSIUM FOR RENAL FAILURE BLOOD THERAPY, ESPECIALLY HOME HEMODIALYSIS

• US 20140042092A1
• Filed: 08/16/2013
• Published: 02/13/2014
• Est. Priority Date: 04/16/2010
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Akonur, Alp, Leypoldt, John Kenneth, Agar, Baris Ugar, Lo, Yin-Cheng
• Granted Patent: US 9,132,219 B2
• Time in Patent Office: Days
• US Class Current: 210/646
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1611 Weight of the patient
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2202/0498 Urea
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

A method of predicting serum potassium concentrations in a patient during hemodialysis includes measuring serum potassium concentrations of the patient over a hemodialysis treatment session time and an ultrafiltration rate calculated by a difference between pre- and post-dialytic body weight of the patient during an initial hemodialysis treatment session divided by a total treatment time of the treatment session and estimating a potassium mobilization clearance and a pre-dialysis distribution volume of potassium for the patient. Serum potassium concentrations of the patient can then be predicted at any time during any hemodialysis treatment session with the estimated potassium mobilization clearance and pre-dialysis distribution volume of potassium of the patient.

Claims

1. A method of predicting serum potassium concentrations in a patient during hemodialysis, the method comprising:

measuring serum potassium concentrations (“

C”

) of the patient over a hemodialysis treatment session time and an ultrafiltration rate (“

Q_UF”

) calculated by a difference between pre- and post-dialytic body weight of the patient during an initial hemodialysis treatment session divided by a total treatment time of the treatment session;

estimating K_M and V_PRE for the patient using a non-linear least squares fitting to the equations;

2. The method of claim 1, wherein K_M is determined using the equation:

3. The method of claim 1, wherein D is determined using the equation:

4. The method of claim 3, wherein D is calculated by assuming that K_OA is 80% or about 80% of that for urea.

5. The method of claim 3, wherein K_OA is determined for using the equation:

6. The method of claim 1, wherein C of the patient is measured every 15 minutes during the hemodialysis treatment session.

7. The method of claim 1, wherein C of the patient is measured every 30 minutes during the hemodialysis treatment session.

8. The method of claim 1, wherein t_tx is 2 hours.

9. The method of claim 1, wherein t_tx is 4 hours.

10. The method of claim 1, wherein t_tx is 8 hours.

11. The method of claim 1, wherein T is 30 minutes.

12. The method of claim 1, wherein T is 1 hour.

13. The method of claim 1 comprising determining V_POST using the equation:

V_POST=V_PRE−

Q_UF×

t_tx 

 

(eqn. 1-I)

and providing therapy to the patient based on the value of V_POST.

14. A method of predicting serum potassium concentrations in a patient during hemodialysis, the method comprising:

measuring serum potassium concentrations (“

C”

) of the patient over a hemodialysis treatment session time for an ultrafiltration rate (“

Q_UF”

)=0 during an initial hemodialysis treatment session;

estimating K_M and V_PRE for the patient using a non-linear least squares fitting to the equations;

15. The method of claim 14, wherein K_M is determined using the equation:

16. The method of claim 14, wherein D is determined using the equation:

17. The method of claim 16, wherein D is determined using the equation:

18. The method of claim 16, wherein D is calculated by assuming that K_OA is 80% or about 80% of that for urea.

19. The method of claim 16, wherein K_OA is determined using the equation:

20. The method of claim 14, wherein C of the patient is measured every 15 minutes during the hemodialysis treatment session.

21. The method of claim 14, wherein C of the patient is measured every 30 minutes during the hemodialysis treatment session.

22. The method of claim 14, wherein the total duration of the hemodialysis treatment session is 2 hours.

23. The method of claim 14, wherein the total duration of the hemodialysis treatment session is 4 hours.

24. The method of claim 14, wherein the total duration of the hemodialysis treatment session is 8 hours.

25. The method of claim 14, wherein T is 30 minutes.

26. The method of claim 14, wherein T is 1 hour.

27. The method of claim 14 comprising determining V_POST using the equation:

V_POST=V_PRE 

 

(eqn. 2-J)

and providing therapy to the patient based on the value of V_POST.

28. A computing device comprising:

a display device;

an input device;

a processor; and

a memory device that stores a plurality of instructions, which when executed by the processor, cause the processor to operate with the display device and the input device to;

(a) receive data relating to serum potassium concentrations (“

C”

) of a hemodialysis patient over a hemodialysis treatment session time and an ultrafiltration rate (“

Q_UF”

) calculated by a difference between pre- and post-dialytic body weight of the hemodialysis patient during a hemodialysis treatment session divided by a total treatment time of the treatment session;

(b) estimate K_M and V_PRE for the patient using a non-linear least squares fitting to the equations;

29. The computing device of claim 28, wherein if Q_UF=0, then

30. The computing device of claim 28, wherein the processor operates with the display device and the input device to receive data relating to at least one of K_R, D or a sampling time for collecting the serum potassium concentration.

31. A method of determining steady state, pre-dialysis serum potassium levels in a hemodialysis patient, the method comprising:

obtaining a net generation of potassium (“

G”

) of the hemodialysis patient_;

determining steady state, pre-dialysis serum potassium levels (“

C_SS-PRE”

) of the hemodialysis patient using the equation;

32. The method of claim 31, wherein n C_tx and n C_i are determined using the equations:

33. The method of claim 31, wherein there is negligible net ultrafiltration or fluid removal from the patient during hemodialysis therapies and no weight gain between hemodialysis therapies, Q_UF=0, and wherein n C_tx and n C_i are determined using the equations:

34. The method of claim 32, wherein the patient parameter is G, K_M or V_PRE.

35. The method of claim 31, wherein the treatment parameter is t_tx, D or F.

36. The method of claim 32, wherein K_M is determined using the equation:

37. The method of claim 31, wherein G is calculated using the equation:

38. The method of claim 31, wherein D is determined using the equation:

39. The method of claim 38, wherein D is calculated by assuming that K_OA is 80% or about 80% of that for urea.

40. The method of claim 38, wherein K_OA is determined using the equation:

41. The method of claim 31 comprising determining a level of potassium intake so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

42. The method of claim 31 comprising determining a potassium binder administered to the patient so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

43. The method of claim 31 comprising determining a total hemodialysis treatment session time so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

44. The method of claim 31 comprising determining the frequency F so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

45. The method of claim 31 comprising determining a required blood flowrate and/or a dialysate flowrate so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

46. The method of claim 31 comprising determining an amount of potassium added to the dialysate so that C_SS-PRE of the hemodialysis patient ranges between about 3.5 mEq/L and 5.3 mEq/L.

47. The method of claim 31, wherein K_M and V_PRE are determined by measuring serum potassium concentrations (“

C”

) of the hemodialysis patient over a hemodialysis treatment session time and an ultrafiltration rate (“

Q_UF”

) calculated by a difference between pre- and post-dialytic body weight of the patient during an initial hemodialysis treatment session divided by a total treatment time of the treatment session, and calculating K_M and V_PRE for the hemodialysis patient using a non-linear least squares fitting to the equations;

48. A computing device comprising:

a display device;

an input device;

a processor; and

a memory device that stores a plurality of instructions, which when executed by the processor, cause the processor to operate with the display device and the input device to;

(a) receive data relating to a net generation of potassium (“

G”

) from at least a dietary potassium intake of a hemodialysis patient or a urea kinetic modeling of the hemodialysis patient;

(b) determine steady state, pre-dialysis serum potassium levels (“

C_SS-PRE”

) of the patient using the equation;

49. The computing device of claim 48, wherein the processor operates with the display device and the input device to receive data relating to at least one of C_D, D, K_R, K_M, V_PRE, t_tx, F and C_PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum potassium concentration,

wherein K_M is a potassium mobilization clearance of the patient, V_PRE is a pre-dialysis distribution volume of potassium of the patient, and C_PRE is a pre-dialysis plasma potassium concentration.

50. The computing device of claim 48, wherein the computing device displays a treatment regimen of the hemodialysis patient so that C_SS-PRE is within a desired range.

51. A computing device comprising:

a display device;

an input device;

a processor; and

a memory device that stores a plurality of instructions, which when executed by the processor, cause the processor to operate with the display device and the input device to;

(a) determine a net generation of potassium (“

G”

) using the equation;

52. The computing device of claim 51, wherein the processor operates with the display device and the input device to receive data relating to at least one of C_D, D, K_R, K_M, V_PRE, t_tx, F and C_PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum potassium concentration,

wherein K_M is a potassium mobilization clearance of the patient, V_PRE is a pre-dialysis distribution volume of potassium of the patient, and C_PRE is a pre-dialysis plasma potassium concentration.

53. The computing device of claim 51, wherein the computing device displays a treatment regimen of the hemodialysis patient so that C_SS-PRE is within a desired range.