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Control the Dialysis Dose
Diascan ® Kt/V Control the Dialysis Dose
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Why Monitor to Control Dialysis Dose During Every Treatment?
25% of dialysis treatments are not delivered as prescribed Collection techniques for lab samples can vary Laboratory errors can occur during processing of lab © 2007 Gambro Lundia AB Rev F
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Up to One in 4 Dialysis Treatments Are Not Delivered As Prescribed
A study published in 1997 showed that of the treatments with a lower Kt/v the most frequent causes were: Treatment times were less than what was prescribed Access recirculation which decreased the amount of blood processed Blood flow delivered was less than what was prescribed © 2007 Gambro Lundia AB Rev F
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Collection Techniques for Lab Samples
A questionnaire regarding collection techniques for lab samples was sent to a random sample of 202 dialysis units participating in a NKF collaborative study © 2007 Gambro Lundia AB Rev F
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The Results of That Study Found That There Was A:
5% error in lab samples collected pre-dialysis 8% - 42% error in lab samples collected post dialysis Large variability in collection techniques for lab samples collected post dialysis Large variability in the timing of when lab samples were drawn © 2007 Gambro Lundia AB Rev F
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Collection Technique Errors for Lab Samples
Some of the errors found in this study were: Dilution of the pre-dialysis lab sample with heparin or saline Obtaining a post dialysis lab sample from recirculated, rather than systemic blood Excessive delay in obtaining a post dialysis lab sample © 2007 Gambro Lundia AB Rev F
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Urea Measurement Errors
Another study found that up to 55% of patients had a month to month variation in urea Kt/v that would alter the determination of whether they are adequately treated Read the slide. These studies confirm the clinical usefulness of utilizing conductivity monitoring to assess delivered dose of dialysis with every treatment. © 2007 Gambro Lundia AB Rev F
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Kt/v Laboratory Results
Typically there is a +/- 25% confidence interval around urea kinetic model derived data for Kt/v. This is due to assumptions about the dialyzer clearance and the patient’s volume used in the calculations © 2007 Gambro Lundia AB Rev F
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Controlling the Dialysis Dose Improves Dialysis Therapy
According to Gotch: A substantial improvement in the quality of dialysis therapy can be obtained using conductivity monitoring Monitoring the delivered dose of dialysis at each treatment can provide a level of precision not known in the past © 2007 Gambro Lundia AB Rev F
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Diascan® The conductivity control and monitor system in dialysis machines is a highly accurate measurement system that is available to be exploited for other applications such as Diascan Diascan is a monitoring system that allows real time, non-invasive, and automatic monitoring of patient and dialyzer parameters It computes these parameters from conductivity measurements made on the dialysate side © 2007 Gambro Lundia AB Rev F
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Conductivity Can Be Used to Measure Clearance
Sodium is measured by conductivity on the dialysis machine For example: ms/cm conductivity would be approximately equal to 140 mEq/l sodium Conductivity measurement by a dialysis machine is 10 times more precise than sodium measurement by a laboratory The size of ionized sodium (NaCl) is 58.5 Daltons and urea is 60 Daltons. Therefore these two substances will have the same ability to cross the dialyzer membrane © 2007 Gambro Lundia AB Rev F
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Several Independent Studies Show Urea Clearance Directly Correlates to Ionic Clearance
100 200 300 400 Ionic Clearance (ml/min) Urea Clearance ml/min Oggionno n = 84 Paris n = 87 London n = 191 These three, independent controlled studies show that there is a direct correlation between Urea Kt/V and Ionic Kt/V Ref: L Mercadal (Paris) - EDTA 98 Ref: R. Lindsay (London-Ontario) - ASN 97 Ref: Di Filippo (Oggionno) - unpublished data 97 12
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Correlation between Kt/V as measured by urea and Ionic Kt/V
2.0 1.5 0.5 1.0 Ionic Kt/V Urea Kt/V In this more recent controlled study, there is a direct correlation between Urea Kt/V and Ionic Kt/V Ref: McIntyre, NDT, 2003 © 2007 Gambro Lundia AB Rev F
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Ionic Clearance Ionic Clearance is the average clearance per minute of ionized substances, for example: sodium correlated to urea removal Reflective of actual removal of waste products from the body Reflects everything that is occurring during a patient’s treatment, i.e. dialyzer size, pump speed, dialysate flow, treatment time, access recirculation, etc. © 2007 Gambro Lundia AB Rev F
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Plasma Conductivity (PC)
PC represents plasma ionic concentration, for example: sodium PC governs intra/extra cellular shifts by altering concentration gradients A patient’s PC can be used to determine conductivity levels for conductivity profiling The patient’s plasma water sodium is approximately equal to 10 x PC 10 x 14.0 ms/cm PC = 140 mEq/l plasma water sodium © 2007 Gambro Lundia AB Rev F
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Plasma Conductivity (PC) and Patient Plasma Sodium
Dialysate conductivity is comprised of about 95% sodium which effects the dialysate’s osmolality Changes to the dialysate’s conductivity result in changes to the dialysate’s osmolality For example: increases to the conductivity result in an increase to the dialysate’s osmolality Patient plasma water is comprised of about 95% sodium which effects the patient’s osmolality Changes to the dialysate’s conductivity result in changes to the patient’s plasma water and osmolality For example: increases to the conductivity result in an increase to the patient’s osmolality © 2007 Gambro Lundia AB Rev F
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Plasma Sodium as compared to Plasma Conductivity (PC):
130 135 140 145 150 13.5 14.0 14.5 15 Plasma Water Sodium mEq/l (Na pw) PC mS/cm This axis indicates patient serum sodium levels The data points fall within a directly proportional line which indicates that there is a direct correlation between serum sodium and Diascan readings This axis indicates PC levels as measured by Diascan® 10 x PC ≈ Na pw Ref: F.Locatelli et al. IJAO 1995. © 2007 Gambro Lundia AB Rev F
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The studies just referenced confirm the clinical usefulness of utilizing conductivity monitoring to assess delivered dose of dialysis with every treatment © 2007 Gambro Lundia AB Rev F
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PC and Ionic Mass Balance
Diascan® displays plasma conductivity(pc) and ionic mass balance (IMB) on the conductivity view IMB is an estimation of the cumulative amount of sodium (in mmol) removed during the treatment This is useful for: Evaluating Na and UF profiles Providing information on patient’s inter-dialytic sodium intake IMB will vary based on conductivity and UFR © 2007 Gambro Lundia AB Rev F
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Ionic Mass Balance (IMB) allows the physician to approximately evaluate the amount of sodium removed during the treatment Patient plasma conductivity approximates the patient’s serum sodium. Multiply the plasma conductivity by 10 (13.85 x 10 ≈ mEq/L) Diascan displays Plasma Conductivity and Ionic Mass Balance in the Conductivity view. (Press “Enter” twice) What is Ionic Mass Balance? Ionic Mass Balance is an estimation of the cumulative total of sodium (in mmol) transferred across the dialyzer membrane during the treatment. Again since dialysate is 95% sodium we can measure how much sodium is being transferred. IMB is: Useful for evaluating Na and UF profile Useful information on patients inter-dialytic sodium intake Will vary based on Conductivity and UFR Also note on this slide that Diascan readings were taken hourly and that at the 2 hour mark the machine came out of conductivity. (Press “Enter” three times to point out these conductivity changes) © 2007 Gambro Lundia AB Rev F
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Ionic Measurement of Clearance (Kt/V or Kt)
Diascan® provides the physician with an indication of dialysis efficiency every treatment by measuring ionic clearance, Ionic Kt/V If the patient’s dry weight and Volume of Distribution is not entered into Diascan, only a Kt value will be displayed Diascan provides information about patient plasma conductivity to assist the physician in making decisions for conductivity profiling The clinical benefit is that EACH dialysis treatment can be monitored for clearance providing a trend for quality assurance. This is used in addition to the monthly labs but not to replace monthly Kt/V lab samples © 2007 Gambro Lundia AB Rev F
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Ref : From Dr Fourmont - AFIDTN 1998
Quality Assurance of Kt/V 0.25 0.5 0.75 1 1.25 1.5 1.75 2-Jan 7-Jan 9-Jan 16-Jan 19-Jan 21-Jan 23-Jan 26-Jan 28-Jan 30-Jan 6-Feb 9-Feb 11-Feb 13-Feb 16-Feb 20-Feb 23-Feb 25-Feb 27-Feb 2 Months follow up of Ionic Kt/V Ref : From Dr Fourmont - AFIDTN 1998 This Quality Assurance tool shows that this patient is being adequately treated even though there were four treatments that did not adequately meet his regular dialysis dose © 2007 Gambro Lundia AB Rev F
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One Biosensor: Two Purposes
Ionic Measurement: One Biosensor: Two Purposes Measurement of Ionic Clearance 2. Measurement of Plasma Conductivity (PC) © 2007 Gambro Lundia AB Rev F
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Measurement of Ionic Clearance and PC
The value derived from these measurements closely determines the patient’s sodium level which allows the determination of PC and Ionic Clearance Ionic Clearance is reflective of actual removal of waste products from the body Outlet conductivity then monitors for a change in value of inlet conductivity The machine automatically changes the inlet conductivity (1 mS/cm over 2 minutes) © 2007 Gambro Lundia AB Rev F
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Clinical Significance of Ionic Clearance
At a Blood Flow Rate of 300 ml/min Blood pump Outlet conductivity If the Ionic Clearance is 200 ml/min Inlet conductivity Then 200 mL of blood are cleared of urea and made equal to the dialysate ionic content Ionic Clearance represents the quantity of blood cleared each minute © 2007 Gambro Lundia AB Rev F
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References Desassis, J., Dallaporta, B., Zins, B., Dupuis, E., Kolko, A., Hemidialysis, E. Rist Medical Center, Paris, France. [PUB432] Establishment of a Relation between In Vitro Urea Clearance of Dialyser and In Vivo Ionic Dialysance: A Step towards the Use of Ionic Dialysance as a Tool for Quality Control in Hemodialysis. ASN (ABS) 2003 2003 McIntyre, C.W., Lambie, S.H., Taal, M. W., Fluck, R. J. Assessment of haemodialysis adequacy by ionic dialysance: intra-patient variability of delivered treatment. Nephrol Dial Transplant (2003) 18: 2002 Gotch, Frank A. On-line Clearance: Advanced Methodology to Monitor Adequacy of Dialysis at No Cost. Contrib Nephrol. Basel, Karger, 2002, vol 137, pp Katopodis, K.P., Hoenich, N.A., Accuracy and clinical utility of dialysis dose measurement using online ionic dialysance. Clinical Nephrology, Vol. 57-No. 2/2002 ( ) 2002 Roldau, R., Kuhlmann, U., Samadi, N., Gross, M., Graf, t., Orlandini, G., Marcelli, D., Lange, H. Ionic Dialysance Measurement Is Urea Distribution Volume Dependent: A New Approach to Better Results Artificial Organs, 26(4): © 2007 Gambro Lundia AB Rev F
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References L. Mercadal, S. Tezenas Du Montoel, M. Chantal Jaudon, A. Hamani, H. Izzedine, G. Deray, B. Bene, T. Petitclerc. Ionic dialysance vs urea clearance in the absence of cardiopulmonary recirculation. Nephrology Dialysis Transplantation (2002)17; Lindsay, Bene, Goux, Heidenheim, Landgren, Sternby. Relationship between Effective Ionic Dialysance and In Vivo Urea Clearnace During Hemodialysis. American Journal of Kidney Diseases, Vol. 38, No 3 (September), (2001): pp Chumlea, Guo, Zeller, Reo, Baumgartner, Garry, Wang, Pierson, Heymsfield, Siervogel. Total Body Water reference values and prediction equations for adults. Kidney International, Vol. 59 (2001) pp 2001 Kuhlman, U., Goldau, R., Samadi, N., Graf, T., Gross, M., Orlandini, G., Lange, H. Accuracy and safety of online clearance monitoring based on conductivity variation. Nephrol Dial Transplant (2001) 16: © 2007 Gambro Lundia AB Rev F
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References 2001 Lindsay, Bene, Goux, Heidenheim, Landgren, Sternby Relationship between Effective Ionic Dialysance and In Vivo Urea Clearnace During Hemodialysis. American Journal of Kidney Diseases, Vol. 38, No 3 (September), (2001): pp 2001 J P Kooman, F M van der Sande, K M L Leunissen Kt.V: finding the tree within the woods. Nephrology Dialysis Transplantation (2001) 16: 2001 Chumlea, Guo, Zeller, Reo, Baumgartner, Garry, Wang, Pierson, Heymsfield, Siervogel. Total Body Water reference values and prediction equations for adults. Kidney International, Vol. 59 (2001) pp 2001 Castro, Romao, Marcondes. Measurement of blood urea concentration during haemodialysis is not an accurate method to determine equilibrated post-dialysis urea concentration. Nephrol Dial Transplant (2001) 16: 2001 DiFilippo, S., Manzoni, C., Andrulli, S., Pontoriero, G., Dell’Oro, C., LaMilia, V., Bacchini, G., Crepaldi, M., Bigi, M.C., Locatelli, F. How to determine ionic dialysance for the online assessment of delivered dialysis dose. Kidney International, Vol. 59 (2001), pp © 2007 Gambro Lundia AB Rev F
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References 2000 Locatelli, Di Filippo, Manzoni. Relevance of the conductivity kinetic model in the control of sodium pool. Kidney International, Vol. 58, Supp. 76 (2000) pp S-89-S-95. M D’Amico, S Colzani, S Andrulli, C Manzoni, S Di Filippo, F Locatelli How to determine ionic dialysance for the online assessment of delivered dialysis dose. Nephrology Dialysis Transplantation Vol. 15 n. 9, A198. Petitclerc, T. Recent developments in conductivity monitoring of haemodialysis session. Nephrology Dialysis Transplantation (1999) 14: 1998 F. Maduell, J. Garcia-Valdecasas, H. Garcia, J. Hdez-Jaras, F Sigilenza, C del Pozo, R. Griner, R. Moll, E. Garrigos. Urea Reduction Ratio Considering Urea Rebound. Nephron 1998;78: 1998 J A Beto, V K Bansal, T S Ing, J T Daugirdas. Variation in Blood Sample Collection for Determination of Hemodialysis Adequacy. American Journal of Kidney Diseases, Vol. 31, No 1 (January) 1998: pp © 2007 Gambro Lundia AB Rev F
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References 1998 Del Vecchio, L., DiFilippo, S., Andrulli, S., Manzoni, C., Corti, M., Barbisoni, F., Locatelli, F. Conductivity: on-line monitoring of dialysis adequacy. INT.J. ARTIF.ORGANS 21, 9, (1998) 1998 DiFilippo, Andrulli, Manzoni, Corti, Locatelli. On-line assessment of delivered dialysis dose. Technical Note. Kidney International, Vol. 54 (1998) pp 1998 Clovic, Goldsmith, Hill, Venning, Ackrill. Urea kinetic modelling—are any of the “bedside” Kt/V formulae reliable enough? Nephrol Dial Transplant (1998) 13: 1996 Manzoni, Di Filippo, Corti, Locatelli. Ionic dialysance as a method for the on-line monitoring of delivered dialysis without blood sampling. Nephrol Dial Transplant (1996) 11: 1995 Petitclerc, Bene, Jacobs, Jaudon, Goux. Non-invasive monitoring of effective dialysis dose delivered to the haemodialyis patient. Nephrol Dial Transplant (1995) 10: © 2007 Gambro Lundia AB Rev F
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Caution: Federal Law (USA) restricts this device to sale, by or on the order of a physician
Read Instructions for Use prior to patient application Trademarks used herein are owned by or licensed to Gambro.Inc © 2007 Gambro Lundia AB Rev F
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