Therapy prediction and optimization for renal failure blood therapy, especially home hemodialysis

• US 8,868,350 B2
• Filed: 04/15/2011
• Issued: 10/21/2014
• 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, Lo, Ying-Cheng, Agar, Baris Ugur
• Primary Examiner(s): Breene, John
• Assistant Examiner(s): BLOSS, STEPHANIE E
• Application Number:
  US13/088,044
• Publication Number:
  US 20110257891A1
• Time in Patent Office: 1,285 Days
• Field of Search: 210/646, 210/647, 210/739, 210/96.2, 604/5.01, 604/4.01, 604/6.01, 604/6.09, 604 65- 67, 702/19, 600/309, 600/322, 436103-105
• US Class Current: 702/19
• 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 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• 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 phosphorus concentrations in a patient during hemodialysis includes measuring serum phosphorus 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 phosphorous mobilization clearance and a pre-dialysis distribution volume of phosphorus for the patient. Serum phosphorus concentrations of the patient can then be predicted at any time during any hemodialysis treatment session with the estimated phosphorous mobilization clearance and pre-dialysis distribution volume of phosphorus of the patient.

Claims

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

measuring serum phosphorus 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_D is determined using the equation:

3. The method of claim 1, wherein K_D is determined for any time t using the equation:

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

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

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

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

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

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

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

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

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

V_POST=V_PRE−

Q_UF×

t_tx

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

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

measuring serum phosphorus 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;

14. The method of claim 13, wherein K_D is determined using the equation:

15. The method of claim 13, wherein K_D is determined for any time t using the equation:

16. The method of claim 13, wherein K_M is determined using the equation:

17. The method of claim 13, wherein C of the patient is measured every 15 minutes during the hemodialysis treatment session.

18. The method of claim 13, wherein C of the patient is measured every 30 minutes during the hemodialysis treatment session.

19. The method of claim 13, wherein t_tx is 2 hours.

20. The method of claim 13, wherein t_tx is 4 hours.

21. The method of claim 13, wherein t_tx is 8 hours.

22. The method of claim 13, wherein T is 30 minutes.

23. The method of claim 13, wherein T is 1 hour.

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

V_POST=V_PRE

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

25. 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 phosphorus 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;

26. The computing device of claim 25, wherein if Q_UF=0, then

27. The computing device of claim 25, wherein the processor operates with the display device and the input device to receive data relating to at least one of K_R, K_D or a sampling time for collecting the serum phosphorus concentration.

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

obtaining a net generation of phosphorus (“

G”

) of the hemodialysis patient;

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

C_SS-PRE”

) of the hemodialysis patient using the equation;

29. The method of claim 28, wherein n C_tx and n C_i are determined using the equations:

30. The method of claim 28, 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:

31. The method of any one of claim 29 or 30, wherein the patient parameter is G, K_M or V_PRE.

32. The method of claim 29 or 30, wherein the treatment parameter is t_tx, K_D or F.

33. The method of claim 29 or 30, wherein K_M is determined using the equation:

34. The method of claim 28, wherein G is calculated using the equation:

35. The method of claim 28, wherein K_D is determined using the equation:

36. The method of claim 28, wherein K_D is determined for any time t using the equation:

37. The method of claim 28, wherein G is determined using the equation:

38. The method of claim 28 comprising determining a level of phosphorus intake so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

39. The method of claim 28 comprising determining a phosphorus binder administered to the patient so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

40. The method of claim 28 comprising determining the total hemodialysis treatment session time so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

41. The method of claim 28 comprising determining the frequency F so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

42. The method of claim 28 comprising determining a required blood flowrate and/or a dialysate flowrate so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

43. The method of claim 28 comprising determining an amount of phosphorus salt supplements added to the dialysate so that C_SS-PRE of the hemodialysis patient ranges between about 3.6 mg/dl and 5.0 mg/dl.

44. The method of claim 28, wherein K_M and V_PRE are determined by measuring serum phosphorus 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;

45. 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 phosphorus (“

G”

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

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

C_SS-PRE”

) of the patient using the equation;

46. The computing device of claim 45, wherein the processor operates with the display device and the input device to receive data relating to at least one of K_R, K_D, K_M, V_PRE, t_tx, F, C_PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus concentration.

47. The computing device of claim 45, wherein the computing device displays a treatment regimen of the hemodialysis patient so that C_SS-PRE is within a desired range.

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) determine a net generation of phosphorus (“

G”

) 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 K_R, K_D, K_M, V_PRE, t_tx, F, C_PRE about a month before a hemodialysis treatment session or a sampling time for collecting the serum phosphorus 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.