Apparatus and method for automatically performing peritoneal equilibration tests

• US 5,670,057 A
• Filed: 04/28/1995
• Issued: 09/23/1997
• Est. Priority Date: 04/28/1995
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Chen, Chi, Emerson, Paul, Keshaviah, Prakash
• Primary Examiner(s): Kim, John
• Application Number:
  US08/434,302
• Time in Patent Office: 879 Days
• Field of Search: 210/645, 210/646, 210/647, 210/739, 210/929, 210/85, 210/86, 210/97, 210/252, 604/28, 604/29, 604/30, 604/65, 364/413.01, 364/413.02
• US Class Current: 210/739
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation

Abstract

There is disclosed a method and apparatus for automatically conducting peritoneal equilibration testing. The method involves removing a sample of overnight dwell fluid from a patient in an amount sufficient to determine the concentration of a metabolite in the drain fluid. The concentration of the metabolite in the sample is then detected and the overnight dwell fluid is drained and weighed. A known weight of dialysate fluid is instilled into a patient and thereafter there are periodically withdrawn samples of the dialysate fluid and the concentration of metabolite in each sample is determined. The ratio of metabolite concentration of each of the periodically drawn samples to metabolite concentration for the overnight dwell fluid is determined. The patient is then drained after a predetermined dwell time and the volume of drained dialysate is determined. The mass transfer area coefficient of the patient'"'"'s peritoneal membrane is then obtained as a function of the measured variables. Means are provided for conducting the method for each of the steps described.

Claims

1. A method of automatically conducting peritoneal equilibration tests, comprising:

removing a sample of overnight dwell fluid through a line from a patient in an amount sufficient to determine the concentration of a metabolite therein, said line being connected to control means for controlling removal of said sample;

detecting the concentration of at least one metabolite in said sample of overnight dwell fluid with detecting means for detecting said concentration, said detecting means being connected to said line and associated with said control means;

draining all overnight dwell fluid from a patient through said line under control of said control means to result in a drained overnight dwell fluid, and determining the weight of said drained overnight dwell fluid with weight means for weighing, associated with said control means;

instilling a known weight of dialysate fluid into a patient through said line under control of said control means;

periodically drawing samples of said dialysate fluid, under control of said control means, to result in periodically drawn samples of dialysate fluid, and determining the concentration of the metabolite in each one of said periodically drawn samples of dialysate fluid, with said detecting means;

determining the ratio of said metabolite concentration detected for each one of said periodically drawn samples of dialysate fluid to the metabolite concentration detected of said sample of overnight dwell fluid or other estimate of plasma water concentration, said determination being done by said control means;

draining the patient of said instilled dialysate fluid after a predetermined dwell time under control of said control means, and determining the volume of said drained dialysate fluid; and

determining the mass transfer area coefficient of the patient'"'"'s peritoneal membrane as a function of said known volume of dialysate fluid infused, known volume of drained dialysate fluid and the determined ratios of said metabolite concentration for each of said periodically drawn samples of dialysate fluid, to the metabolite concentration of said sample of overnight dwell fluid or other estimate of plasma water concentration.

2. A method as in claim 1 wherein said plasma water concentration is C_On determined from said periodically drawn samples of dialysate fluid by performing a curve fit to a one minus exponential function of the form C_Do +(P-C_Do) 1-e.sup.γ

(t-to) !, where C_Do is a first plasma water concentration at a time "t₀ ", "t" is the time at which respective periodically drawn samples are drawn, "P" is a number empirically correlated to the plasma water concentration, and "γ

" is an independent parameter of a Levenberg-Marguardt nonlinear fitting method, so that C_ON =mP+b, where "m" and "b" are determined from a database of peritoneal equilibration test (PET) data.

3. A method as in claim 2 wherein said metabolite measured further comprises one of creatinine and phosphate.

4. A method as in claim 3 further comprising measuring a plurality of different metabolites.

5. A method as in claim 1 wherein said metabolite measured is urea or creatinine.

6. A method as in claim 1 wherein said ratios of concentration of metabolite in the overnight sample to concentration for any periodically drawn sample of dialysate fluid is used to project the ratio at any given time based on the slope of in (1-C_Di /C_ON) versus t_i which is assumed to be a straight line, where t_i is the time at which any sample is withdrawn, C_Di is the concentration of metabolite for any periodically drawn sample of dialysate fluid, so that said ratio at time t is -(exp (f (slope_urea)t+intercept)-1.0), where f (slope) is an empirically derived function of said slope.

7. A method as in claim 6 wherein said metabolite measured is urea or creatinine.

8. A method as in claim 1 wherein the mass transfer area coefficient calculated is compared to a set of standard values to determine the degree of transport of a patient'"'"'s peritoneal membrane.

9. A method as in claim 1 wherein said plasma water concentration is C_ON determined from said periodically drawn samples of dialysate fluid by performing a curve fit to a one minus exponential function of the form C_Do +(P-CD_Do) 1-e.sup.γ

(t-to) !, where C_Do is a first plasma water concentration at a time "t₀ ", "t" is the time at which respective periodically drawn samples are drawn, "P" is a number empirically correlated to the plasma water concentration, and "γ

" is an independent parameter determined from a nonlinear least squares fitting method, so that C_On =mP+b, where "m" and "b" are determined from a database of peritoneal equilibration test (PET) data.

10. An apparatus for automatically conducting peritoneal equilibration tests, comprising:

means for removing a sample of overnight dwell fluid from a patient for determining the amount of a metabolite in said sample;

means for detecting the concentration of metabolite in said sample;

means for draining all overnight dwell fluid from a patient and for instilling a known weight of dialysate fluid into said patient;

means for weighing said overnight dwell fluid drained from said patient;

said means for removing a sample of overnight dwell fluid being also for periodically drawing samples of instilled dialysate fluid and said means for detecting being for detecting the amount of metabolite in each periodically drawn sample;

means for determining the volume of said instilled dialysate after withdrawal from said patient after a predetermined dwell time; and

calculating means for determining the mass transfer area coefficient of the patient'"'"'s peritoneal membrane as a function of the determined volume of dialysate infused, known volume of drained dialysate and the ratios of the determined metabolite for each periodically drawn sample to the determined metabolite in the sample of overnight dwell fluid or other estimate of the plasma water concentration.

11. An apparatus as in claim 10 further comprising means for determining the plasma water concentration from periodically drawn samples of dialysate fluid by performing a curve fit to a one minus exponential function of the form C_Do +(P-C_Do) 1-e.sup.γ

(t-to) !, where C_Do is a first plasma water concentration at time "t₀ ", "t" is the time at which respective periodically drawn samples are drawn, "P" is a number empirically correlated to the plasma water concentration, and "γ

" is an independent parameter of a Levenberg-Marguardt nonlinear fitting method, for having C_ON =mP+b, where "m" and "b" are determined from a database of peritoneal equilibration test (PET) data.

12. An apparatus as in claim 11 further comprising means for measuring at least one of creatinine and phosphate.

13. An apparatus as in claim 12 wherein said means for measuring further comprises means for measuring a plurality of different metabolites.

14. An apparatus as in claim 10 wherein said means for detecting is for detecting the concentration of urea or creatinine.

15. An apparatus as in claim 10 further comprising means for projecting the ratio of concentration of metabolite in the overnight sample to concentration of any periodically drawn sample at any time based on a calculation of ln (1-C_Di /C_ON) versus t_i which is assumed to be a straight line, where t_i is the time at which any sample is withdrawn, C_Di is the concentration of any referenced sample withdrawn at different times t_i and C_ON is the overnight dwell sample concentration.

16. An apparatus as in claim 15 wherein said means for detecting is for detecting the concentration of urea or creatinine.

17. An apparatus as in claim 10 further comprising comparing means for comparing the mass transfer area coefficient calculated to a set of stored standard values to determine the degree of area and permeability of a patient'"'"'s peritoneal membrane.

18. An apparatus as in claim 10 further comprising means for determining the plasma water concentration from periodically drawn samples of dialysate fluid by performing a curve fit to a one minus exponential function of the form C_Do +(P-C_Do) 1-e.sup.γ

(t-to) !, where C_Do is a first plasma water concentration at time "t₀ ", "t" is the time at which respective periodically drawn samples are drawn, "P" is a number empirically correlated to the plasma water concentration, and "γ

" is an independent parameter determined from a nonlinear least squares fitting method, so that C_ON =mP+b, where "m" and "b" are determined from a database of peritoneal equilibration test (PET) data.