Device for extracorporeal blood treatment and method for calculating the heat balance in an extracorporeal blood treatment device

Abstract

An apparatus for extracorporeal blood treatment comprising a control unit (100) programmed to calculate, during extracorporeal blood treatment, a mass balance rate (J soln ) of a selected solute as a function of solute concentration (C soln ) in dialysis fluid and / or infusion fluid, as a function of patient solute concentration (Cp soln ), as a function of fluid flow rate (Qpbp, Qpre, Qpost, Qdial, Qanc) and as a function of filtration flow rate (Qfil) or patient fluid removal rate (Qpfr); calculate an energy balance (E soln ) generated by the selected solute as a function of the calculated mass balance rate (J soln ) and as a function of specific energy load (Emet soln ) of each solute.

Description

Technical Field

[0001] This invention relates to an apparatus for extracorporeal blood processing and a method for calculating heat balance.

[0002] Extracorporeal blood processing involves removing blood from a patient, processing the blood outside the patient's body, and returning the processed blood to the patient. Extracorporeal blood processing is commonly used to remove unwanted substances or molecules from a patient's blood and to add desired substances or molecules to the blood. Extracorporeal blood processing is used for patients who cannot effectively remove substances from their blood, such as when a patient has temporary or permanent kidney failure. For example, these and other patients may receive extracorporeal blood processing to add or remove substances from their blood to maintain acid / base balance, remove excess body fluid, or perform extracorporeal gas exchange procedures.

[0003] This invention relates primarily to a continuous renal replacement therapy (CRRT) system. The CRRT system is configured to provide treatment designed for patients in an acute disease state who have temporarily and completely lost their renal function. The CRRT monitor should be able to provide various treatment methods (SCUF, CCVH, CVVHDF). Background Technology

[0004] During extracorporeal blood treatment, the exchange of substances between the device used for extracorporeal blood treatment and the patient also implies the exchange of energy / thermal loads. These energy / thermal loads are generated due to solutes in the treatment fluid. The treatment fluid is a potential source of these heats, which can be difficult to identify and may lead to complications of over- or under-supply.

[0005] For example, continuous renal replacement therapy (CRRT) treatments aid energy uptake by providing patients with glucose and citrate, particularly during regional citrate anticoagulation (RCA). This treatment generates significant energy when citrate is infused into patients at levels higher than physiological. The literature by New et al. (“Continuous renal replacement therapy: a potential source of calories in the critically ill” Am J Clin Nutr 2017; 105:1559-63) discloses that the caloric load of citrate and glucose (when using the anticoagulant citrate dextran solution, solution A (ACD-A)) during continuous venous-venous hemofiltration (CVVH) has been estimated to exceed 500 kcal / day, equivalent to approximately 30% of a patient's daily energy requirements. In the case of ACD-A combined with a high-lactate replacement fluid, CRRT treatment can provide over 1300 kcal / day.

[0006] Excessive energy intake (overfeeding) is associated with a variety of complications in critically ill patients, including hypercapnia, liver dysfunction, azotemia, immune dysfunction, and hyperglycemia, and may also be associated with increased mortality in patients in the intensive care unit (ICU).

[0007] Currently, when performing extracorporeal blood processing, the energy / heat load generated by the solutes in the treatment fluid is not taken into account, which may lead to the aforementioned oversupply complications.

[0008] The object of the present invention is to provide a device for extracorporeal blood processing that reduces, minimizes or compensates for the above-mentioned disadvantages.

[0009] The purpose of this invention is to provide patients with a better energy balance (load or loss) during extracorporeal blood processing.

[0010] The purpose of this invention is to avoid excessive supply during in vitro blood processing.

[0011] The purpose of this invention is to reduce the risk of critical illness in patients receiving this treatment, particularly to reduce multiple complications in critically ill patients and improve their outcomes.

[0012] Another objective of this invention is to raise awareness among staff about the fact that this treatment provides heat to patients.

[0013] Another objective of this invention is to improve the comfort of patients receiving this treatment.

[0014] Another objective of this invention is to reduce the workload of clinical staff. Summary of the Invention

[0015] The device according to one or more of the appended claims achieves at least one of the above objectives individually or in any combination.

[0016] The present invention provides an extracorporeal blood processing apparatus and method that enables the assessment of the exchange of energy / heat load to / from the patient due to at least one solute in the treatment fluid during processing.

[0017] The following describes apparatuses and methods according to various aspects of the present invention that are capable of achieving one or more of the above-described objectives.

[0018] In a first independent aspect, an apparatus for extracorporeal blood processing is provided, comprising:

[0019] A blood circuit, coupled to the processing unit, includes a blood removal line and a blood return line that can be connected to the patient's vascular system;

[0020] A blood pump, configured as a pump section coupled to a blood circuit;

[0021] The effluent line connects to the processing unit;

[0022] At least one infusion line and / or dialysis line, at least one infusion line being connected to the blood circuit and the dialysis line being connected to the processing unit;

[0023] In this embodiment, at least one infusion line and dialysis line are connected to or are capable of being connected to at least one source of at least one fluid;

[0024] The control unit, at least connected to the blood pump, is programmed to receive:

[0025] The solute concentration of at least one selected solute in at least one fluid;

[0026] At least one patient parameter related to the patient solute concentration of at least one selected solute in the patient's blood; optionally, the patient parameter is the patient solute concentration;

[0027] The specific energy load of at least one selected solute;

[0028] The measured or set fluid flow rate of at least one fluid passing through at least one infusion line and / or dialysis line;

[0029] The filtration flow rate or the patient fluid removal rate measured or set in the processing unit.

[0030] During extracorporeal blood processing, the control unit is programmed to:

[0031] Calculate the mass balance rate of at least one selected solute based on solute concentration, patient parameters, fluid flow rate, and filtration flow rate or patient fluid removal rate.

[0032] The energy balance resulting from at least one selected solute during in vitro blood processing is calculated based on the calculated mass balance rate and the specific energy load.

[0033] Optionally, the control unit is programmed to receive the blood flow rate through the blood circuit.

[0034] Optionally, the extracorporeal blood processing is programmed to also calculate the energy balance based on the blood flow rate.

[0035] In a second independent aspect, a method is provided for calculating the heat balance in a device for extracorporeal blood processing, wherein the method includes:

[0036] Considering:

[0037] The solute concentration of at least one selected solute in at least one fluid passing through at least one infusion line and / or dialysis line of a device for extracorporeal blood processing;

[0038] At least one patient parameter related to the patient solute concentration of at least one selected solute in the patient's blood; optionally, the patient parameter is the patient solute concentration;

[0039] Specific energy loading of at least one selected solute;

[0040] The measured or set fluid flow rate of at least one fluid in at least one infusion line and / or dialysis line;

[0041] The filtration flow rate or the patient fluid removal rate is measured or set in the processing unit of a device for extracorporeal blood processing.

[0042] During extracorporeal blood processing:

[0043] Calculate the mass balance rate of at least one selected solute based on solute concentration, patient parameters, fluid flow rate, and filtration flow rate or patient fluid removal rate; and

[0044] The energy balance generated during in vitro blood processing due to at least one selected solute is calculated based on the calculated mass balance rate and the specific energy load.

[0045] The concentration of at least one selected solute in the patient's blood can be plasma concentration, plasma water concentration, or whole blood concentration.

[0046] In the third aspect according to aspect 1 or 2, the control unit is connected to the interface and configured to display the calculated energy balance through the interface, or the method includes displaying the calculated energy balance through the interface; optionally, the device for extracorporeal blood processing includes the interface.

[0047] In the third aspect according to aspect 1, 2 or 3, the control unit is connected to an infusion pump for administering nutritional products to a patient and is configured to also control the infusion pump based on a calculated energy balance, or the method includes controlling the infusion pump based on a calculated energy balance.

[0048] In the third aspect according to aspect 3, the device includes or is connected to an application device configured to administer a nutritional product to a patient during extracorporeal blood processing; the application device includes a nutrient line and an infusion pump coupled to the nutrient line; the nutrient line is in fluid communication with a nutrient bag and a blood return line and / or directly in fluid communication with the patient.

[0049] In the third or fourth aspect according to aspect 1, 2 or 3, the control unit is connected to a support tool (Clinical Decision Support, CDS) for processing nutrition, which is installed on a computer; the computer is connected to an administration device configured to administer nutritional products to a patient, the administration device including a nutrition line and an infusion pump coupled to the nutrition line; the support tool is also configured to control the infusion pump based on an energy balance calculated from the control unit.

[0050] In the fourth aspect according to any one of aspects 1 to 3, calculating the energy balance includes multiplying the mass balance rate of at least one selected solute by its respective specific energy load to obtain the energy balance of the selected solute.

[0051] In the fifth aspect according to any one of aspects 1 to 4, the energy balance is calculated using the following equation:

[0052] E soln =J soln x Emet soln

[0053] in:

[0054] E soln The energy balance of the selected solute n;

[0055] J soln The mass equilibrium rate of the selected solute n;

[0056] Emet soln The specific energy loading of the selected solute n;

[0057] in:

[0058] J soln >0 is the solute used to be added to the patient; and

[0059] J soln <0 is the solute used for removal from the patient.

[0060] In the sixth aspect according to any one of aspects 1 to 5, at least one selected solute comprises a plurality of selected solutes, and the control unit is programmed to sum the energy balance of all selected solutes, or the method comprises summing the energy balance of all selected solutes to obtain a total energy balance due to the selected solutes.

[0061] In the seventh aspect according to aspect 6, calculating the energy balance includes multiplying the mass balance rate of each selected solute by its respective specific energy load to obtain the energy balance of each selected solute.

[0062] In the eighth aspect as described in aspect 6 or 7, the total energy balance is calculated using the following equation:

[0063] E = ∑E soln =∑J soln x Emet soln

[0064] in:

[0065] E. Total energy balance;

[0066] E soln The energy balance of the selected solute n;

[0067] J soln The mass equilibrium rate of the selected solute n;

[0068] Emet soln The specific energy loading of the selected solute n.

[0069] In the ninth aspect according to any one of aspects 1 to 8, the control unit is programmed to calculate the mass balance rate of at least one selected solute or each selected solute as the difference between the rate of the selected solute entering the blood and the rate of the selected solute leaving the blood, or the method includes calculating the mass balance rate of at least one selected solute or each selected solute as the difference between the rate of the selected solute entering the blood and the rate of the selected solute leaving the blood.

[0070] In the tenth aspect according to any one of aspects 1 to 9, the mass balance of at least one selected solute or each selected solute is calculated using the following equation:

[0071] J soln =Jinf soln -Jeff soln

[0072] in:

[0073] J soln The mass equilibrium rate of the selected solute n;

[0074] Jinf soln The rate at which the selected solute n enters the bloodstream;

[0075] Jeff soln The rate at which the selected solute n leaves the blood.

[0076] In the eleventh aspect according to aspect 9 or 10, the control unit is programmed to calculate the rate of at least one selected solute or each selected solute entering the blood based on the fluid flow rate of at least one fluid passing through at least one infusion line and based on the solute concentration in said at least one fluid, or the method includes calculating the rate of at least one selected solute or each selected solute entering the blood based on the fluid flow rate of at least one fluid passing through at least one infusion line and based on the solute concentration in said at least one fluid.

[0077] In the 12th aspect according to any one of aspects 9 to 11, the rate of entry into the bloodstream of at least one selected solute or each selected solute is calculated using the following equation:

[0078] Jinf soln =Qinf p x Cinf soln

[0079] in:

[0080] Jinf soln The rate at which the selected solute n enters the bloodstream;

[0081] Qinf p The flow velocity of the fluid passing through the infusion line p;

[0082] Cinf psoln The concentration of the selected solute n in the infusion pipeline p.

[0083] In the 13th aspect according to any one of aspects 1 to 12 above, at least one infusion line includes: a pre-blood pump line and / or a pre-infusion line and / or a post-infusion line and / or at least one auxiliary infusion line; optionally, at least one auxiliary infusion line includes: an anticoagulant solution line, such as a heparin line or a citrate line and / or a calcium line.

[0084] In the 14th aspect according to aspect 13, as described in any one of aspects 9 to 12, the rate of at least one selected solute entering the bloodstream, or the rate of each selected solute, is calculated using the following equation:

[0085] Jinf soln =Qpbp Cpbp soln +Qpre Cpre soln +Qpost Cpost soln +Qanc Canc soln

[0086] in:

[0087] Jinf soln The rate at which the selected solute n enters the bloodstream;

[0088] Qpbp is the flow rate of the fluid passing through the pre-blood pump line;

[0089] Qpre is the flow rate of the fluid passing through the pre-infusion line;

[0090] Qpost refers to the flow rate of fluid passing through the post-infusion line;

[0091] Qanc refers to the flow rate of fluid passing through the auxiliary pipeline;

[0092] Cpbp soln The concentration of solute n selected in the pre-blood pump line;

[0093] Cpre soln The concentration of the selected solute n in the pre-infusion line;

[0094] Cpost soln The concentration of solute n selected in the post-infusion line;

[0095] Canc soln The concentration of the selected solute n in the auxiliary pipeline.

[0096] In any of aspects 9 to 12 and 14, or in the 15th aspect according to aspect 13 when any of aspects 9 to 12, the control unit is programmed to calculate the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the filtration flow rate and patient parameters, or the method includes calculating the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the filtration flow rate and patient parameters.

[0097] In the 16th aspect according to aspect 15, the control unit is programmed to calculate the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the fluid flow rate of the fluid flowing through the dialysis line, or the method includes calculating the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the fluid flow rate of the fluid flowing through the dialysis line.

[0098] In the 17th aspect according to aspect 15 or 16, the control unit is programmed to calculate the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the clearance of the solute for the processing unit, or the method includes calculating the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood based on the clearance of the solute for the processing unit.

[0099] In the 18th aspect according to aspect 17, the control unit is programmed to calculate a clearance rate based on the diffusion mass transfer coefficient of the solute for the processing unit, or the method includes calculating a clearance rate based on the diffusion mass transfer coefficient of the solute for the processing unit.

[0100] In the 19th aspect according to aspect 18, the control unit is programmed to calculate clearance based on parameters of the filtration flow rate, the fluid flow rate of the fluid passing through the dialysis tubing, the blood flow rate in the blood circuit, and the patient's blood, or the method includes calculating clearance based on parameters of the filtration flow rate, the fluid flow rate of the fluid passing through the dialysis tubing, the blood flow rate in the blood circuit, and the patient's blood.

[0101] In the 20th aspect according to aspect 19, the parameters of the patient's blood include:

[0102] α soln The partition coefficient of solute n between plasma water and red blood cells (RBCs);

[0103] βkin soln An empirical parameter (dependent on solute kinetics across the RBC membrane) is defined as the fraction of RBC water volume to be considered in mass transfer calculations for solute n.

[0104] Fp plasma water volume fraction;

[0105] Frbc (fraction of water volume in erythrocytes);

[0106] Hct hematocrit

[0107] In the 21st aspect according to any one of aspects 17 to 20, the control unit is programmed to calculate the clearance rate by the following equation, or the method includes calculating the clearance rate by the following equation:

[0108] K soln =[(Qwinlet x Qdial)-(f soln x(Qwinlet-Qfil)x(Qdial+Qfil))] / [Qdial-f soln x(Qwinlet-Qfil)]

[0109] in:

[0110] f soln =[((Qwinlet-Qfil) / Qwinlet)x((Qdial+Qfil) / Qdial)] 1 / γsoln

[0111] γ soln =exp(Qfil / (K0) soln )x S)-1

[0112] Qfil=Qpbp+Qpre+Qpost+Qpfr+Qanc

[0113] Qwinlet=Qpwinlet+(βkin soln xα soln x Qrbcwinlet)

[0114] Qpwinlet=Qpw+Qpbp+Qpre+Qanc=Fp x(1-Hct)x Qb+Qpbp+

[0115] Qpre+Qanc

[0116] Qrbcwinlet=Qrbcw=Frbc x Qrbc=Frbc x Hct x Qb

[0117] in:

[0118] K0 soln The diffusion mass transfer coefficient of solute n used in the processing unit;

[0119] S-processing unit filter surface area;

[0120] α soln The partition coefficient of solute n between plasma water and red blood cells (RBCs);

[0121] βkin soln An empirical parameter (dependent on solute kinetics across the RBC membrane) is defined as the fraction of RBC water volume to be considered in mass transfer calculations for solute n.

[0122] Fp plasma water volume fraction;

[0123] Frbc (fraction of water volume in erythrocytes);

[0124] Hct hematocrit;

[0125] Qfil filter flow rate;

[0126] Qpbp is the flow rate of the fluid passing through the pre-blood pump line;

[0127] Qpre is the flow rate of the fluid passing through the pre-infusion line;

[0128] Qanc refers to the flow rate of fluid passing through the auxiliary pipeline;

[0129] The flow rate of the fluid passing through the dialysis tubing in Qdial;

[0130] Qb blood flow rate;

[0131] Qwinlet filter inlet water flow rate;

[0132] Qrbcw Red blood cell water flow rate;

[0133] Qpw plasma flow rate.

[0134] The diffusion mass transfer coefficient of solute n, "K0" soln "Specific to each filter membrane-solute combination. The filter type of the processing unit can be known to the control unit, and the product "K0" soln "x S" can be a value embedded in the control unit. For example, once a filter is installed, the filter type data can be automatically recognized by the control unit, or it can be entered by querying the user.

[0135] In the 22nd aspect according to aspect 16, the control unit is programmed to calculate the clearance rate using the following approximation (simplified equation), or the method includes calculating the clearance rate using the following approximation (simplified equation):

[0136] K sol =Qfil + Qdial

[0137] in:

[0138] K sol Clearance rate;

[0139] Qfil filter flow rate;

[0140] The flow rate of the fluid passing through the dialysis tubing in Qdial.

[0141] In the 23rd aspect according to any one of aspects 15 to 21, the control unit is programmed to calculate the concentration of a selected solute at the inlet of the processing unit based on patient parameters, and to calculate the rate at which the selected solute leaves the blood based on the concentration of the selected solute at the inlet of the processing unit, or the method includes calculating the concentration of a selected solute at the inlet of the processing unit based on patient parameters, and to calculate the rate at which the selected solute leaves the blood based on the concentration of the selected solute at the inlet of the processing unit.

[0142] In the 24th aspect according to aspect 23, the control unit is programmed to calculate the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood using the following equation, or the method includes calculating the rate of at least one selected solute leaving the blood or the rate of each selected solute leaving the blood using the following equation:

[0143] Jeff soln =Qdial x Cdial soln +K soln x(Cpw_inlet soln -Cdial soln )+Qfil x

[0144] Cdial soln

[0145] in:

[0146] Jeff soln The rate at which the selected solute n leaves the blood;

[0147] The flow rate of the fluid passing through the dialysis tubing in Qdial;

[0148] Cdial soln The concentration of the selected solute n in the dialysis tubing;

[0149] K soln The clearance rate of solute n;

[0150] Qfil filter flow rate;

[0151] Cpw_inlet soln The concentration of the selected solute n (plasma water concentration) at the inlet of the processing unit.

[0152] In the 25th aspect according to aspect 23 or 24, the concentration of the selected solute at the inlet of the processing unit is a function of the concentration of the selected solute n in the patient's blood.

[0153] In the 26th aspect according to aspect 23, 24, or 25, the control unit is programmed to calculate the concentration of a selected solute at the inlet of the processing unit using the following equation, or the method includes calculating the concentration of a selected solute at the inlet of the processing unit using the following equation:

[0154] Cpw_inlet soln =(Qw Cpw soln +Qpbp Cpbp soln +Qpre Cpre soln +Qanc

[0155] Canc soln ) / (Qwinlet)

[0156] in:

[0157] Qw=Qpw+βkin soln α soln Qrbcw=[Fp(1-Hct)+βkin soln α soln

[0158] Frbc Hct]Qb

[0159] Qwinlet=Qpwinlet+(βkin soln α soln Qrbcwinlet)

[0160] Qpwinlet=Qpw+Qpbp+Qpre+Qanc=Fp(1-Hct)Qb+Qpbp+

[0161] Qpre+Qanc

[0162] Qrbcwinlet=Qrbcw=Frbc Qrbc=Frbc Hct Qb

[0163] in:

[0164] Cpw_inlet soln The concentration of the selected solute n (plasma water concentration) at the inlet of the processing unit; α soln The partition coefficient of solute n between plasma water and red blood cells (RBCs);

[0165] βkin solnAn empirical parameter (dependent on solute kinetics across the RBC membrane) is defined as the fraction of RBC water volume to be considered in mass transfer calculations for solute n.

[0166] Fp plasma water volume fraction;

[0167] Frbc (fraction of water volume in erythrocytes);

[0168] Hct hematocrit;

[0169] Cpbp soln The concentration of solute n selected in the pre-blood pump line;

[0170] Cpre soln The concentration of the selected solute n in the pre-infusion line;

[0171] Canc soln The concentration of solute n selected in the auxiliary pipeline;

[0172] Qpbp is the flow rate of the fluid passing through the pre-blood pump line;

[0173] Qpre is the flow rate of the fluid passing through the pre-infusion line;

[0174] Qanc refers to the flow rate of the fluid passing through the auxiliary pipeline;

[0175] Qb blood flow rate;

[0176] Cpw soln The patient's solute concentration (plasma water concentration) of the selected solute n in the patient's blood.

[0177] In accordance with aspect 3, or in aspect 27 of any of aspects 4 to 26, the control unit is programmed to receive patient parameters via an interface, or the method includes receiving patient parameters via an interface.

[0178] In the 28th aspect according to any one of aspects 1 to 27, the control unit is operatively connected to or capable of being connected to a device configured to measure and / or store patient parameters; the control unit is configured to receive patient parameters from said device.

[0179] In aspect 29 as described in aspect 28, the device configured to measure and / or store patient parameters is an online monitoring device or analyzer, such as a hospital blood gas analyzer or electronic medical record (EMR) system.

[0180] In the 30th aspect according to aspect 29, the apparatus for extracorporeal blood processing includes the means configured to measure and / or store patient parameters.

[0181] In the 31st aspect according to any one of aspects 27 to 30, the blood concentration parameter may be the patient's plasma solute concentration or the patient's plasma aqueous solute concentration, and the control unit is programmed to receive the patient's plasma solute concentration and calculate the patient's plasma aqueous solute concentration, or the method includes receiving the patient's plasma solute concentration and calculating the patient's plasma aqueous solute concentration.

[0182] In aspect 32, as described in any one of aspects 1 to 31, patient parameters are measured, estimated, or set.

[0183] In aspect 33 according to any one of aspects 1 to 32, at least one selected solute includes citrate and / or glucose and / or lactate and / or other metabolites such as carbohydrates, protein peptides, ketone bodies, amino acids, and triglycerides.

[0184] In aspect 34 as described in aspect 33, the patient’s blood glucose concentration is correlated with energy balance via a table or chart.

[0185] In aspect 35 as described in aspect 33, the concentration of citrate in the patient's blood is set to be equal to zero or estimated as the steady-state patient citrate concentration.

[0186] In aspect 36 as described in aspect 33, the mass balance of citrate is calculated by assuming a steady state of patient citrate concentration.

[0187] In the 37th aspect according to aspect 36, the control unit is programmed to calculate the mass balance rate of citrate using the equations of aspects 14 and 24 and the following equation, or the method includes calculating the mass balance rate of citrate using the equations of aspects 14 and 24 and the following equation:

[0188] J cit =Cp cit x K cit_met

[0189] Qp x Cp cit +Qpbp x Cpbp cit +Qpre x Cpre cit =Qpwinlet x Cpw_inlet cit

[0190] in:

[0191] Qp plasma flow rate

[0192] Plasma flow rate at the inlet of the Qpwinlet processing unit

[0193] Cp cit Patient plasma systemic citrate concentration

[0194] K cit_met Patient citrate metabolism clearance rate

[0195] In aspect 38 as described in aspect 33, the concentration of lactate in the patient's blood is correlated with energy balance via a table or chart.

[0196] In aspect 39, as described in any one of aspects 1 to 36, each infusion line is connected to its respective fluid source.

[0197] In the 40th aspect according to any one of aspects 1 to 39, the at least one fluid includes dialysis fluid and / or replacement fluid and / or anticoagulant solution, such as citrate or heparin.

[0198] In the 41st aspect according to any one of aspects 1 to 40, the device for extracorporeal blood processing is a continuous renal replacement therapy (CRRT) device.

[0199] In aspect 42 as described in aspect 41, the CRRT device is configured to provide various treatments, such as CCVH, CVVHDF, and SCUF.

[0200] In the 43rd aspect according to any one of aspects 1 to 42, the device for extracorporeal blood processing is configured to apply local citrate anticoagulation (RCA).

[0201] In aspect 44 as described in aspect 43, an anticoagulant citrate dextran solution (solution A (ACD-A)) is used to apply local citrate anticoagulant (RCA).

[0202] In the 45th aspect according to any one of aspects 1 to 43, the control unit is programmed to calculate the heat balance (load or loss) over a given time period by integrating the energy balance over that time period, such as the daily heat balance, or the method includes calculating the heat balance (load or loss) over that time period by integrating the energy balance over that time period, such as the daily heat balance.

[0203] Other features of the invention will become more apparent from the following detailed description of some embodiments of the invention, illustrated by means of non-limiting examples in the accompanying drawings. Attached Figure Description

[0204] The description will now refer to the accompanying drawings provided by way of non-limiting embodiments, in which:

[0205] - Figure 1 An extracorporeal blood processing device according to the present invention is illustrated schematically;

[0206] - Figure 2 This is a flowchart of a method for calculating heat balance according to the present invention. Detailed Implementation

[0207] Figure 1 The diagram schematically illustrates a device 1 for extracorporeal blood processing. Device 1 can be a continuous renal replacement therapy (CRRT) device configured to provide various treatments such as CCVH, CVVHDF, and SCUF. Device 1 includes a processing or filtering unit 2 having a main chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5. Depending on the treatment, the semipermeable membrane 5 of the processing unit 2 can be selected to have different properties and performance.

[0208] The blood circuit is coupled to the main chamber 3 of the processing unit 2. The blood circuit includes a blood removal line 6 connected to an inlet 3a of the main chamber 3 and a blood return line 7 connected to an outlet 3b of the main chamber 3. The blood removal line 6 and the blood return line 7 are configured to connect to the cardiovascular system of the patient “P”.

[0209] In use, the blood removal line 6 and the blood return line 7 are connected to a needle, catheter, or other access device, which is then positioned in fluid communication with the patient's "P" vascular system, allowing blood to be drawn through the blood removal line 6, flow through the main chamber 3, and then return to the patient's vascular system through the blood return line 7. An air separator (such as a degassing chamber 8) may be present on the blood return line 7. Additionally, a monitoring valve 9 may be present on the blood return line 7, downstream of the degassing chamber 8. Blood flow through the blood circuit is controlled by a blood pump 10 (e.g., a peristaltic blood pump) acting on the blood removal line 6 or the blood return line 7. Figure 1 The implementation shows a blood pump 10 coupled to a pump section of a blood removal line 6.

[0210] The dialysis circuit is connected to the secondary chamber 4 of the filtration unit 2 and includes a dialysis line 11 connected to an inlet 4a of the secondary chamber 4 and an effluent line 12 connected to an outlet 4b of the secondary chamber 4 and connected to a discharge pipe (not shown). An effluent pump 13 is located on the effluent line 12 and is capable of recovering fluid from the secondary chamber 4. The dialysis line 11 is connected to a source 14 of fresh dialysis fluid, such as a bag or preparation device, and the dialysis pump 15 is located on the dialysis line 11 and is capable of pumping fluid into the secondary chamber 4.

[0211] The device 1 also includes an infusion circuit, which includes at least one infusion line. Figure 1 The infusion circuit shown in the implementation scheme includes a pre-blood pump line 16, a pre-infusion line 17, and a post-infusion line 18.

[0212] A pre-infusion line 16 is connected to a blood removal line 6 upstream of the blood pump 10 and to a first source 19 for infusion fluid, such as a bag. A pre-infusion pump 20 is located on the pre-infusion line 16 and is capable of pumping fluid from the first source 19 into the blood circuit. A pre-infusion line 17 is connected to the blood removal line 6 downstream of the blood pump 10 and upstream of the processing unit 2, and is connected to a second source 21 for infusion fluid, such as a bag. A pre-infusion pump 22 is located on the pre-infusion line 17 and is capable of pumping fluid from the second source 21 into the blood circuit.

[0213] The pre-infusion line 18 is connected downstream of the processing unit 2 to the blood return line 7 and to a third source 23 for the infusion fluid, such as a bag. The post-infusion pump 24 is located on the post-infusion line 18 and is capable of pumping fluid from the third source 23 to the blood circuit.

[0214] The infusion circuit may also include two auxiliary infusion lines: namely, a heparin line 25 with a syringe 26 and a citrate line 27 with a citrate bag 28. These two auxiliary lines are already in place with all other infusion lines. Figure 1 The diagram is shown, but as described in detail below, it will be used depending on the type of treatment being performed. In practice, some treatments may require only citrate anticoagulation or only heparin anticoagulation, while another line may be absent or removed. In certain specific treatments without any anticoagulation, both auxiliary lines may be absent.

[0215] The control unit 100 connects to and controls the blood pump 10, effluent pump 13, dialysis pump 15, pre-blood pump 20, pre-infusion pump 22, and post-infusion pump 24 to regulate the blood flow rate "Qb" in the blood circuit, the fluid flow rate "Qdial" through the dialysis line 11, the fluid flow rate "Qeff" through the effluent line 12, the fluid flow rate "Qpbp" through the pre-blood pump line 16, the fluid flow rate "Qpre" through the pre-infusion line 17, and the fluid flow rate "Qpost" through the post-infusion line 18. The control unit 100 can also control the syringe 26 and / or pump on the citrate line 27 to control the supply and flow rate "Qanc" of auxiliary fluids (such as heparin and / or citrate solution). By controlling the fluid flow rate "Qdial" through the dialysis line 11 and / or the fluid flow rate "Qeff" through the effluent line 12, the control unit 100 is also configured to control / regulate the filtration flow rate "Qfil" and / or the patient fluid removal rate "Qpfr" in the processing unit 2. A flow rate sensor (not shown) may be placed on the infusion line and connected to the control unit 100 for better control of the fluid supply and flow rate.

[0216] Control unit 100 may be an electronic control unit including at least a CPU, memory, and input / output devices. Control unit 100 includes or is connected to interface 110, which is configured to display data and / or allow user input of data. For example, the interface includes a display, such as a touch screen, and / or buttons or a keyboard.

[0217] The dialysis fluid and infusion fluid may contain a solute with an energy / caloric load, and the control unit 100 is able to assess the exchange of energy / caloric load to / from the patient “P” due to the solute during treatment.

[0218] The solute may include any solute with an energy / caloric load, such as citrate and / or glucose and / or lactate and / or other metabolites, such as protein peptides, ketone bodies, amino acids, triglycerides.

[0219] Infusion fluids may include replacement fluids and / or anticoagulant solutions, such as citrate or heparin.

[0220] Energy / heat balance (load or loss) can be displayed by interface 110 to help clinical staff take responsibility for the effects of said balance imposed by treatment.

[0221] Energy / heat balance can also be used to perform further automated control of device 1.

[0222] For example, the device includes an administration device 130 configured to administer a nutritional product to patient P during treatment. Such an administration device 130 includes a nutrition line 131 having a first end in fluid communication with a nutrition bag 132 and a second end for infusing the nutritional product (e.g., as a nutritional solution) into a blood return line 7 or directly into the patient's vascular system. An infusion pump 133 is coupled to the nutrition line 131 to deliver the nutritional product.

[0223] The control unit 100 is connected to the infusion pump 133 and is configured to also control the infusion pump 133 based on the calculated energy / caloric balance to deliver the correct amount of nutritional product. Thus, the amount of nutritional product administered to patient P also takes into account the calculated energy / caloric load from the solute.

[0224] The control unit can also be connected to a clinical decision support system (CDS – not shown in the figure) for handling nutrition, which is installed on a computer. The computer is connected to an administration device configured to administer nutritional products to the patient, the administration device including a nutrition line and an infusion pump coupled to the nutrition line. The CDS is also configured to control the infusion pump based on a calculated energy balance.

[0225] Furthermore, the control unit 100 can be programmed to calculate the heat balance over a given time period, such as the daily heat balance, by integrating the energy balance over that time period.

[0226] Equation

[0227] In order to calculate the exchange of energy / heat load, the control unit 100 is configured / programmed to receive the following data.

[0228] Prescription parameters for extracorporeal blood processing:

[0229] - Blood flow rate "Qb";

[0230] - The flow rate of the fluid passing through the pre-blood pump line 16 is “Qpbp”;

[0231] - The flow rate of the fluid passing through the pre-infusion line 17, “Qpre”;

[0232] - The flow rate of the fluid passing through the post-infusion line 18, “Qpost”;

[0233] - The flow rate of the fluid passing through dialysis tubing 11 is "Qdial";

[0234] - The flow rate of the fluid passing through auxiliary pipelines 25 and 27 is "Qanc";

[0235] - Filter flow rate "Qfil" or patient fluid removal rate "Qpfr".

[0236] The solute concentration of the selected solute (e.g., citrate, glucose, lactate) in the dialysis fluid and / or infusion fluid, for example:

[0237] -Cpbp soln The concentration of solute n selected in the pre-blood pump line;

[0238] -Cpre soln The concentration of the selected solute n in the pre-infusion line;

[0239] -Cpost soln The concentration of solute n selected in the post-infusion line;

[0240] -Canc soln The concentration of solute n selected in the auxiliary pipeline;

[0241] -Cdial soln The concentration of the selected solute n in the dialysis line.

[0242] Specific energy loading of each selected solute (e.g., citrate, glucose, lactate)

[0243] Emetsoln ".

[0244] Patient data:

[0245] - The concentration of the selected solute (e.g., citrate, glucose, lactate) in the patient's blood (“Cp”) soln "Plasma solute concentration or "Cpw" soln "Plasma water solute concentration";

[0246] -Patient weight "BW";

[0247] -Hematocrit "Hct".

[0248] Other data:

[0249] -α soln The partition coefficient of solute n between plasma water and red blood cells (RBCs);

[0250] -βkin soln An empirical parameter (dependent on solute kinetics across the RBC membrane) is defined as the fraction of RBC water volume to be considered in mass transfer calculations for solute n.

[0251] -Fp = 0.95 plasma water volume fraction (constant);

[0252] -Frbc = 0.85% of the water volume fraction in erythrocytes (constant);

[0253] -K0 soln The diffusion mass transfer coefficient of solute n for the processing unit (specific to each filter membrane-solute combination);

[0254] -S Processing unit filter surface area.

[0255] The data can be input by clinical staff through interface 110, or transmitted from the database portion of device 1 or a remote database connected to device 1 to control unit 100.

[0256] Control unit 100 is programmed / configured to calculate the clearance rate "K" of each "membrane-solute" combination using the following equation. soln ":

[0257] (1)K soln =[(Qwinlet x Qdial)-(f soln x(Qwinlet-Qfil)x(Qdial+Qfil))] / [Qdial-f soln x(Qwinlet-Qfil)]

[0258] in:

[0259] -fsoln =[((Qwinlet-Qfil) / Qwinlet)x((Qdial+Qfil) / Qdial)] 1 / γsoln

[0260] -γ soln =exp(Qfil / (K0) soln )x S)-1

[0261] -Qwinlet=Qpwinlet+(βkin soln xα soln x Qrbcwinlet)

[0262] -Qpwinlet=Qpw+Qpbp+Qpre+Qanc=Fp x(1-Hct)x Qb+Qpbp+Qpre+Qanc

[0263] -Qrbcwinlet=Qrbcw=Frbc x Qrbc=Frbc x Hct x Qb

[0264] Since the previous equation (1) for solute removal requires knowledge of the specific mass transfer coefficient (or resistance) and this parameter may be unknown, the following approximation of solute removal can be considered, especially in the context of CRRT:

[0265] (2)K sol =Qfil + Qdial

[0266] This simplified equation typically overestimates the actual clearance rate.

[0267] Control unit 100 is programmed / configured to calculate the water flow rate "Qw" that matches the solute distribution volume considered for a given solute "n" using the following equation:

[0268] (3)Qw=[Fp x(1-Hct)+βkin soln xα soln x Frbc x Hct]x Qb

[0269] Control unit 100 is programmed / configured to calculate the water flow rate "Qwinlet" at the inlet of processing unit 2, which matches the solute distribution volume considered for a given solute "n", using the following equation:

[0270] (4)Qwinlet=Fp x(1-Hct)x Qb+Qpbp+Qpre+Qanc+(βkin soln xα soln x Frbc x Hctx Qb)

[0271] Control unit 100 is programmed / configured to calculate the concentration "Cpw_inlet" of each selected solute "n" at the inlet of processing unit 2 using the following equation. soln (Plasma water concentration):

[0272] (5)Cpw_inlet soln =(Qw x Cpw) soln +Qpbp x Cpbp soln +Qpre x Cpre soln +Qanc xCanc soln ) / (Qwinlet)

[0273] in:

[0274] -Qw is calculated using equation (3);

[0275] -Qwinlet is calculated using equation (4);

[0276] -Cpw soln It refers to the concentration of water-soluble substances in the patient's plasma.

[0277] Control unit 100 is programmed / configured to calculate the rate "Jinf" of each selected solute "n" entering the bloodstream via the following equation. soln (e.g., in mmol / h) and the rate at which each selected solute "n" leaves the blood (Jeff) soln ":

[0278] (6) Jinf soln =Qpbp x Cpbp soln +Qpre x Cpre soln +Qpost x Cpost soln +Qanc xCanc soln

[0279] (7) Jeff soln =Qdial x Cdial soln +K soln x(Cpw_inlet soln -Cdial soln )+Qfil xCdial soln

[0280] in:

[0281] -K soln Calculate using equation (1) or (2);

[0282] -Cpw_inlet soln Calculate using equation (5).

[0283] Control unit 100 is programmed / configured to calculate the mass balance rate for each selected solute using the following equation:

[0284] (8)J soln =Jinf soln -Jeff soln

[0285] in:

[0286] -Jinf soln Calculate using equation (6);

[0287] -Jeff soln Calculate using equation (7);

[0288] in:

[0289] J soln >0 is the solute used to be added to the patient; and

[0290] J soln <0 is the solute used for removal from the patient.

[0291] Control unit 100 is programmed / configured to calculate total energy balance using the following equation:

[0292] (9) E=∑E soln =∑J soln x Emet soln

[0293] in:

[0294] -E soln Energy balance for each selected solute "n";

[0295] -J soln The mass balance rate of each selected solute “n” calculated by equation (8);

[0296] -Emet soln The specific energy loading of each selected solute "n".

[0297] Patient solute concentration

[0298] To calculate the mass transfer of each selected solute from blood to effluent (Equations 5 and 7), the model requires the solute concentration "Cpw" in the patient's venous blood pumped into the blood circuit. soln ".

[0299] This concentration can be derived from the patient's solute concentration "Cp". soln The measured value can be manually transferred to the control unit 100 (e.g., via a query from the user interface 110) or via device 1 and apparatus 120 (in Figure 1 (Illustrated in the image) The digital connection between the device and the patient is automatically transferred, and the device is configured to measure and / or store patient solute concentrations.

[0300] Such a device 120 can be an online monitoring device or analyzer, such as a blood gas analyzer or electronic medical record (EMR) system in a hospital. Other alternatives could be a device 1 that embeds an online monitoring device or has the ability to periodically generate blood / plasma samples into an integrated measuring device.

[0301] However, the above options may not always be possible (e.g., for citrate), and this will be supported by the assumption that it is specific to each solute.

[0302] Patient glucose concentration

[0303] blood Grape Glucose concentrations are physiologically controlled within a relatively narrow range (baseline 3.9–6.1 mM) and increase significantly after meals (up to 7.8 mM in healthy individuals). Both hypoglycemia and hyperglycemia lead to various systemic symptoms.

[0304] In this situation, displaying an estimate of calorie load without knowing the patient's blood glucose concentration could be seriously misleading. When no patient data is available for the system, an option is to report the dependence of calories on the patient's blood glucose in a table or graph (see Example A4 below).

[0305] Patient citrate concentration

[0306] Citrate is not typically part of standard patient monitoring, and the measurement technology is only available in a limited number of hospitals. In this case, the cited option of accessing the patient's blood concentration appears to be ineffective.

[0307] However, baseline blood citrate concentrations were almost zero (i.e., about 0.1 mM) in healthy subjects and ICU patients who did not receive extracorporeal blood therapy with citrate anticoagulation (RCA). For patients with RCA under CRRT, it could reach levels of about 0.5 mM, and particularly values ​​in the 0.5–1 mM range.

[0308] Therefore, the simple assumption of citrate is to consider zero patient citrate concentration to estimate the heat load.

[0309] A better approach is to integrate a simple estimate of the patient's citrate concentration into the model, assuming a "normal" metabolic clearance rate. The relevant specific equations are reported below.

[0310] The following equation (10) expresses the systemic citrate concentration in the patient's plasma under steady state.

[0311] (10)J cit =Cp cit x K cit_met or Cp cit =J cit / K cit_met

[0312] in:

[0313] K cit_met Patient citrate metabolism clearance rate

[0314] Cp cit Patient plasma systemic citrate concentration

[0315] The patient's citrate metabolism clearance rate can be estimated as 700 x BW / 72.

[0316] Considering Qanc = 0, the previous equation (8) for citrate becomes:

[0317] (11)J cit =(Qpbp x Cpbp) cit +Qpre x Cpre cit +Qpost x Cpost cit )–(Qdial xCdial cit +K cit x(Cpw_inlet cit –Cdial cit )+Qfil x Cdial cit )

[0318] The expression for the citrate plasma water concentration at the inlet of processing unit 2 is as follows:

[0319] (12)Qp x Cp cit +Qpbp x Cpbp cit +Qpre x Cpre cit =Qpwinlet x Cpw_inlet cit

[0320] in:

[0321] Qp plasma flow rate

[0322] Plasma flow rate at the inlet of the Qpwinlet processing unit

[0323] Cp cit Patient plasma systemic citrate concentration

[0324] therefore,

[0325] Cpw_inlet cit=(Qp x Cp) cit +Qpbp x Cpbp cit +Qpre x Cpre cit ) / Qpwinlet

[0326] and

[0327] (13)J cit =(Qpbp x Cpbp) cit +Qpre x Cpre cit +Qpost x Cpost cit )–(Qdial xCdial cit +K cit x(((Qp x Cp cit +Qpbp x Cpbp cit +Qpre x Cpre cit ) / Qpwinlet)–Cdial cit )+Qfil x Cdial cit )

[0328] (14)J cit =[(Qpbp x Cpbp) cit +Qpre x Cpre cit )x(1–K cit / Qpwinlet)+(Qpost xCpost cit )+(K cit –Qfil-Qdial)x Cdial cit ] / [1+(K cit / K cit_met )x(Qp / Qpwinlet)]

[0329] Patient lactate concentration

[0330] In healthy subjects, baseline plasma lactate concentration was approximately 1 ± 0.5 mM and increased significantly with exercise.

[0331] In ICU patients, plasma lactate levels may increase significantly above physiological levels in certain clinical situations, such as septic shock.

[0332] Therefore, in the absence of lactate measurement data provided to the system, the background is relatively similar to that of blood glucose. To prevent misleading information, the caloric load should be reported in tabular or graphical form within the lactate concentration range.

[0333] Another general aspect of patient solute concentration is that plasma concentration "Cp" is usually measured. solnThe equation described (e.g., equation 5) refers to the plasma water concentration "Cpw". soln The protein volume fraction (Fp) should be corrected, assuming the default value or based on the total protein concentration in the plasma.

[0334] Example

[0335] Consider CRRT device 1 and Table 1 below contains definitions and symbols for CRRT flow and fluid composition.

[0336] Table 1

[0337] Loop ID Brief description Flow rate solute concentration Pbp Pre-blood pump infusion Qpbp <![CDATA[Cpbp glu ,Cpbp cit ,Cpbp lac ]]> Pre Pre-filter infusion Qpre <![CDATA[Cpre glu ,Cpre cit ,Cpre lac ]]> Post Post-filtration infusion Qpost <![CDATA[Cpost glu ,Cpost cit ,Cpost lac ]]> Dial dialysis circuit Qdial <![CDATA[Cdial glu ,Cdial cit ,Cdial lac ]]>

[0338] The solutes considered are glucose, citrate, and lactate because they have significant specific energy contribution (defined as the amount of energy produced during metabolism), significant concentrations in the patient or CRRT fluid, and significant mass transfer along the CRRT process.

[0339] The modeling parameters for the selected solute are reported in Tables 2, 3, and 4 below.

[0340] Table 2 - Glucose

[0341]

[0342]

[0343] Table 3 - Citrate

[0344] parameter unit value mw g / mol - <![CDATA[K0 cit x S]]> ml / min 109 <![CDATA[βkin cit ]]> Dimensionless 0 <![CDATA[α cit ]]> Dimensionless - <![CDATA[Emet cit ]]> kJ / mmol 0.66

[0345] Table 4 - Lactate

[0346]

[0347]

[0348] Example A: Citrate anticoagulation using ACD-A solution

[0349] Using ACD-A (anticoagulant citrate dextran solution, solution A) as the anticoagulant solution, a series of examples "A" is established around the citrate anticoagulant formulation; based on the high glucose content of the ACD-A solution, it is assumed that all other fluids are glucose-free. The use of fluids containing lactate (alternatives and dialysate) is also considered in this series of examples.

[0350] The composition of the fluid is shown in Table 5 below.

[0351] Table 5

[0352] fluid circuit pbp pre post dial Glucose (mM) 124 0 0 0 Citrate (mM) 113 0 0 0 Lactate (mM) 0 3 3 3

[0353] Example A1 – CVVHDF Processing Using ACD-A

[0354] Table 6

[0355]

[0356] Table 7

[0357]

[0358] Table 8

[0359]

[0360] Example A2 – Same as A1, the patient has hyperglycemia.

[0361] Table 9

[0362]

[0363]

[0364] Table 10

[0365]

[0366] Example A3 – Same as A1, but with higher dialysis flow rate and CRRT dose.

[0367] Table 11

[0368]

[0369] Table 12

[0370]

[0371] Example A4 – Except for the variable patient glucose concentration, the dependence of the same calories on patient blood glucose as in A1 is reported in Table 12A below.

[0372] Table 12A

[0373]

[0374]

[0375] Assuming an effective treatment time of approximately 22 hours per day, the heat load calculated for the first embodiment A1 corresponds to more than 900 kJ / day; this amount represents approximately 10% of the patient's daily energy expenditure.

[0376] Examples A2, A3, and A4 illustrate the high sensitivity of caloric load to patient parameters (Examples A2 and A4) or prescription parameters (Example A3). In Example A3, with an outflow dose of approximately 40 ml / kg / h, the caloric load decreased to a negligible level (approximately 300 kJ / day). All Examples A show that lactate contributes minimally to patients with moderately elevated lactate levels when combined with solutions containing lactate concentrations above the physiological range.

[0377] Example B: Citrate anticoagulation using a "diluted" citrate solution

[0378] A series of examples, "B," is established around a citrate anticoagulant formulation using a glucose-free, "diluted" citrate solution as the anticoagulant solution. This series of examples also considers the use of lactate-free fluids (alternatives and dialysate).

[0379] The composition of the fluid is shown in Table 13 below.

[0380] Table 13

[0381] fluid circuit pbp pre post dial Glucose (mM) 0 0 6 6 Citrate (mM) 18 0 0 0 Lactate (mM) 0 0 0 0

[0382] Example B1 - Treatment with CVVHDF using diluted citrate - low glycemic range

[0383] Table 14

[0384]

[0385]

[0386] Table 15

[0387]

[0388] Table 16

[0389]

[0390]

[0391] Example B2 – Same as B1, but with a high glycemic range

[0392] Table 17

[0393]

[0394] Table 18

[0395]

[0396] Example B3 - Same as B1, but with a higher CRRT dose

[0397] Table 19

[0398]

[0399]

[0400] Table 20

[0401]

[0402] All “B” embodiments result in a thermal load rate that is negligible relative to the patient’s energy consumption.

[0403] Example B2 is a negative caloric load embodiment, which means that the net effect of CRRT treatment is energy loss via metabolites. Example B2 considers the use of glucose-containing dialysate and infusion fluid; with the use of glucose-free fluid, the caloric loss in Example B2 would be 17.6 kJ / h, which is still negligible to some extent relative to the patient's overall metabolism.

[0404] Example C: No anticoagulant

[0405] A set of examples "C" were established for heparin or non-anticoagulant cases, wherein citrate was not present in any fluid. These examples illustrate the effect of glucose and lactate content in the fluid.

[0406] The fluid compositions of Examples C1 and C2 are shown in Table 21 below.

[0407] Table 21

[0408] fluid circuit pbp pre post dial Glucose (mM) 0 6 6 6 Citrate (mM) 0 0 0 0 Lactate (mM) 0 3 3 3

[0409] Example C1 - CVVH treatment in standard anticoagulant / fluids containing glucose and lactate

[0410] Table 22

[0411]

[0412] Table 23

[0413]

[0414]

[0415] Table 24

[0416]

[0417] Example C1 of two - Same as C1, with unspecified patient lactate and glucose concentrations, the dependence of patient lactate and glucose on calories is reported in Table 24 of two below.

[0418] Table 24 Part 2

[0419]

[0420]

[0421] Example C2 – Same as C1, but with a higher CRRT dose

[0422] Table 25

[0423]

[0424] Table 26

[0425]

[0426]

[0427] Example C3 – Same as C1, but the fluid does not contain glucose or lactate.

[0428] The fluid composition of Example C3 is shown in Table 27 below.

[0429] Table 27

[0430] fluid circuit pbp pre post dial Glucose (mM) 0 6 6 6 Citrate (mM) 0 0 0 0 Lactate (mM) 0 3 3 3

[0431] Table 28

[0432]

[0433] Example C1 illustrates that when patients have “normal” glucose and lactate levels, and when using fluids with glucose and lactate concentrations in the high physiological range (and exceeding lactate levels), a typical CRRT prescription without citrate anticoagulation results in a smaller patient caloric load.

[0434] In this prescription, the increase in CRRT dosage has a marginal effect on heat load.

[0435] On the other hand, using a glucose- and lactate-free fluid significantly shifts the heat load to the negative range, achieving heat loss within 10% of the baseline patient's metabolism (approximately 840 kJ in Example C3).

[0436] Although the invention has been described in conjunction with embodiments that are now considered to be the most practical and preferred, it should be understood that the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications included within the scope of the appended claims.

Claims

1. An apparatus for extracorporeal blood processing, comprising: Processing unit (2); A blood circuit, coupled to the processing unit (2) and including a blood removal line (6) and a blood return line (7) that can be connected to the vascular system of the patient (P). A blood pump (10) is configured to be coupled to the pump portion of the blood circuit; The outflow pipeline (12) is connected to the processing unit (2); At least one infusion line (16, 17, 18, 25, 27) and / or dialysis line (11), the at least one infusion line (16, 17, 18, 25, 27) being connected to the blood circuit, and the dialysis line (11) being connected to the processing unit (2). Wherein, at least one infusion line (16, 17, 18, 25, 27) and / or the dialysis line (11) is connected to or can be connected to a fluid source (14, 19, 21, 23, 26, 28). Control unit (100), at least connected to the blood pump (10) and programmed to receive: The solute concentration (C) of the selected solute in the fluid soln ); The patient solute concentration (Cp) of the selected solute in the patient's blood. soln Relevant patient parameters; The specific energy loading (Emet) of the selected solute soln ); The measured or set fluid flow rate (Qpbp, Qpre, Qpost, Qdial, Qanc) of the fluid flowing in at least one infusion line (16, 17, 18, 25, 27) and / or the dialysis line (11). The processing unit (2) measures or sets the filtration flow rate (Qfil) or the patient fluid removal rate (Qpfr). During the in vitro blood processing, the control unit (100) is programmed to: According to the solute concentration (C) soln Based on the patient parameters, the fluid flow rates (Qpbp, Qpre, Qpost, Qdial, Qanc), and the filtration flow rate (Qfil) or the patient fluid removal rate (Qpfr), the mass balance rate (J) of the selected solute is calculated. soln ); According to the calculated mass balance rate (J) soln And according to the specific energy load (Emet) soln ), calculate the energy balance (E) resulting from the selected solute during the in vitro blood treatment. soln ).

2. The device according to claim 1, wherein, The patient parameter is the patient solute concentration (Cp). soln ).

3. The device according to claim 1, wherein, The control unit (100) is connected to the interface (110) and is configured to display the calculated energy balance (E) through the interface (110). soln ).

4. The device according to claim 1, wherein, The control unit (100) is connected to an infusion pump (133) for administering nutritional products to the patient (P) and is configured to also administer the calculated energy balance (E) according to the calculated energy balance (E) soln ) to control the infusion pump (133).

5. The device of claim 1, comprising or connected to an application device (130) configured to apply a nutritional product to a patient (P) during the extracorporeal blood treatment; the application device (130) comprising a nutrient line (131) and an infusion pump (133) coupled to the nutrient line (131); the nutrient line (131) being in fluid communication with a nutrient bag (132) and with the blood return line (7) or directly with the patient (P).

6. The device according to claim 5, wherein, The control unit (100) is connected to a nutrition support tool installed on a computer; the computer is connected to the application device (130), and the support tool is configured to also control the infusion pump (133) based on the energy balance calculated from the control unit (100).

7. The device according to any one of claims 1 to 6, wherein, The selected solutes include a variety of selected solutes, and the control unit (100) is programmed to balance the energy (E) of each of the selected solutes. sol1 E soln Summing these values ​​yields the total energy balance (E) resulting from the selected solute.

8. The device according to claim 7, wherein, Calculating the energy balance (E) includes: calculating the mass balance rate (J) for each selected solute. soln ) multiplied by their respective specific energy loads (Emet) soln To obtain the energy balance (E) of the selected solute. soln ).

9. The apparatus according to any one of claims 1 to 6, comprising a plurality of sources (14, 19, 21, 23, 26, 28) for each fluid, wherein, Calculate the selected solute (sol) n The mass balance rate (J) soln This includes calculating the mass equilibrium rate (J) of the selected solute. soln ).

10. The device according to any one of claims 1 to 6, wherein, The control unit (100) is programmed to control the mass balance rate (J) of the selected solute. soln ) is calculated as the rate at which the selected solute enters the bloodstream (Jinf) soln ) and the rate at which the selected solute leaves the blood (Jeff soln The difference between ).

11. The device according to claim 10, wherein, The control unit (100) is programmed to adjust the flow rate (Qpbp, Qpre, Qpost, Qanc) of the fluid flowing in the at least one infusion line (16, 17, 18, 25, 27) and the solute concentration (C) in the fluid. soln ), calculate the rate at which the selected solute enters the bloodstream (Jinf soln ).

12. The device according to claim 10, wherein, The control unit (100) is programmed to calculate the rate (Jeff) of the selected solute leaving the bloodstream based on the filtration flow rate (Qfil) and the patient parameters. soln ).

13. The device according to claim 12, wherein, The control unit (100) is programmed to calculate the rate (Jeff) of the selected solute leaving the blood based on the fluid flow rate (Qdial) of the fluid passing through the dialysis tubing (11). soln ).

14. The device according to claim 12, wherein, The control unit (100) is programmed to operate according to the solute removal rate (K) of the processing unit (2). soln ), calculate the rate at which the selected solute leaves the blood (Jeff soln ).

15. The device according to claim 14, wherein, The control unit (100) is programmed to operate according to the diffusion mass transfer coefficient (K0) of the solute for the processing unit (2). soln ), calculate the clearance rate (K) soln ).

16. The device according to claim 12, wherein, The control unit (100) is programmed to calculate the concentration (Cpw_inlet) of the selected solute at the inlet of the treatment unit (2) based on the patient parameters. soln ), and based on the concentration of the selected solute at the inlet of the processing unit (2) (Cpw_inlet) soln ) Calculate the rate at which the selected solute (soln) leaves the blood (Jeff) soln ).

17. The device of claim 12, comprising or connected to a means (120) configured to measure or store the patient parameters, and the control unit (100) being configured to receive the patient parameters from the means (120).

18. The device according to claim 17, wherein, The device (120) configured to measure or store the patient parameters is an online monitoring device or analyzer or a hospital's electronic medical record (EMR) system.

19. The device according to any one of claims 1 to 6, wherein, The selected solute includes citrate, glucose, or lactate.

20. The device according to claim 19, wherein, The patient's blood glucose concentration is correlated with the energy balance using a table or chart.

21. The device according to claim 19, wherein, The citrate concentration in the patient's blood was set to zero or estimated as the steady-state patient citrate concentration.

22. The device according to claim 19, wherein, The concentration of lactate in the patient's blood is correlated with the energy balance using a table or chart.

23. The device according to any one of claims 1 to 6, wherein, The at least one infusion line (16, 17, 18, 25, 27) includes: a pre-blood pump line (16) and / or a pre-infusion line (17) and / or a post-infusion line (18) and / or an auxiliary infusion line (27, 28).

24. The device according to any one of claims 1 to 6, wherein, The fluid may include a replacement fluid or an anticoagulant solution.

25. The device according to any one of claims 1 to 6, wherein, The device used for extracorporeal blood processing is a continuous renal replacement therapy (CRRT) device configured to apply local citrate anticoagulation (RCA).

26. The device according to any one of claims 1 to 6, wherein, The control unit (100) is programmed to calculate the heat balance over a given time period by integrating the energy balance over that time period.

27. The device according to claim 18, wherein, The analyzer in question is a blood gas analyzer.

28. An apparatus for extracorporeal blood processing, comprising: Processing unit (2); A blood circuit, coupled to the processing unit (2) and including a blood removal line (6) and a blood return line (7) that can be connected to the vascular system of the patient (P). Blood pump (10), a pump portion coupled to the blood circuit; The outflow pipeline (12) is connected to the processing unit (2); Dialysis tubing (11) is connected to the processing unit (2); At least one infusion line connected to the blood circuit and comprising one or more of the following: Pre-blood pump tubing; Pre-infusion line; Post-infusion line; and Auxiliary infusion pipeline; Wherein, at least one infusion line and the dialysis line (11) are connected to a fluid source; A control unit (100), connected to the blood pump (10) and programmed to calculate the heat balance over a given time period by integrating the energy balance over that time period, is programmed to receive: The concentration of a selected solute in the fluid, wherein the selected solute includes citrate, glucose, or lactate; The patient solute concentration of the selected solute in the patient's blood; The specific energy loading of the selected solute; The measured or set fluid flow rate of the fluid flowing in at least one infusion line; The measurement or setting of the fluid flow rate in the dialysis line (11); The processing unit (2) measures or sets the filtration flow rate or the patient fluid removal rate. During the in vitro blood processing, the control unit (100) is programmed to: Based on the patient solute concentration, the fluid flow rate in the at least one infusion line, and the filtration flow rate or the patient fluid removal rate, calculate the mass balance rate of the selected solute based on the solute concentration: The energy balance resulting from the selected solute during the in vitro blood treatment is calculated based on the calculated mass balance rate and the specific energy load.

29. The device according to claim 28, wherein, The energy balance is calculated using the following equation: AND soln = J soln x Emet soln in: E soln It is the energy balance of the selected solute n; J soln It is the mass equilibrium rate of the selected solute n; Emet soln It is the specific energy loading of the selected solute n; in: J soln > 0 is the solute to be added to the patient; and J soln < 0 is the solute used for removal from the patient.

Images