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Clinical Evaluation of Novel Methods to Determine Dialysis Parameters Using Conductivity Cells

Dissertationsschrift zur Erlangung des naturwissenschaftlichen Doktorgrades der Bayerischen Julius-Maximilians-Universitt Wrzburg

vorgelegt von Rainer Goldau Wrzburg 2002

Eingereicht am:

1. Gutachter: Prof. Dr. R. Benz

2. Gutachter: Prof. Dr. H. Lange

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Table of ContentsIntroduction .................................................................................................................... 5 1.1. Motivation of the investigation................................................................ 6 1.1.1. The Clearance and the Kt/V concept ..................................................... 8 1.1.2. Kt/V and Mortality .................................................................................10 1.1.3. Urea and Sodium Chloride ...................................................................12 2. Theoretical Considerations............................................................................................13 2.1. The effective dialysance and the effective clearance ............................13 2.2. Relation of ionic Dialysance and Urea Clearance .................................13 2.2.1. The Role of Recirculation .....................................................................14 2.3. Mass Balance.......................................................................................16 2.4. Automatic access to ionic effective dialysance .....................................16 2.4.1 The step-profile.....................................................................................18 2.4.2. The dynamic bolus measurement.........................................................19 2.4.3. True continuous electrolytical dialysance measurement .......................22 2.4.4. Virtual continuous electrolytical dialysance estimation ..........................24 2.4.5. The dialysance measurement is profile type sensitive ..........................28 2.5. Measurement of the urea distribution volume .......................................29 2.5.1. V from direct quantification ...................................................................29 2.5.2. Anthropometrical methods to estimate urea distribution volume ........31 2.5.3. Conductivity based sodium distribution volume measurement ..........32 2.5.4. Single pool urea distribution volume .....................................................38 2.6. Urea kinetics Evaluation of Kt/V.........................................................39 2.6.1. Single pool urea kinetic model ..............................................................40 2.6.2. Kt/V from Direct quantification ..............................................................43 2.6.3. Daugirdas second generation Kt/V formula...........................................43 2.6.4. Double pool urea kinetic model.............................................................44 2.6.5. Two pool urea kinetic model : Mathematical description ......................45 2.6.6. Data analysis of subsequent dialysis sessions .....................................51 2.6.7. Source code of the numerical algorithm kernel .....................................51 2.6.8. The target variable................................................................................52 2.6.9. The set of input parameters for two pool modelling...............................53 2.7. Determination of Plasma Sodium .........................................................58 3. Concept and experimental protocol of the Studies.........................................................60 3.1. Study Design ........................................................................................60 3.1.1. Ethical and legal regulations:................................................................61 3.1.2. General participation criteria.................................................................61 3.1.3. Exclusion criteria: .................................................................................61 3.1.4. Written and informed consent: ..............................................................62 3.1.5. Insurance of the patients: .....................................................................62 3.1.6. Function of the monitor: ........................................................................62 3.1.7. Ethical and administrative supervision: .................................................63 3.1.8. Technical engineering:..........................................................................63 3.1.9. Major goal of the MRI Study: ................................................................63 3.1.10. Major goals of the MRII study: ..............................................................64 3.2. Subjects and Methods ..........................................................................64 3.2.1. The MI Study ........................................................................................64 3.2.1.1. Patient collective and hemodialysis parameters ...................................64 3.2.1.2. On line clearance measurements ( OCM ):...........................................65 3.2.1.3. Monitoring of clinical outcome .........................................66 3.2.2. The MII Study .......................................................................................67 3.3. Refinement of MRII Study.....................................................................69 1.

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The experimental results and first discussion ................................................................70 4.1. The MI Study ........................................................................................70 4.1.1. Comparison of ionic Dialysance to Reference ......................................70 4.1.1.1. Momentary Dialysance Measurements.................................................70 4.1.1.1.1. Clinical outcome ...................................................................................74 4.1.1.2. Integral Dialysis References .................................................................75 4.1.1.2.1. Single pool kinetic model, direct quantification and Daugirdas equation .............................................................................................................75 4.1.1.2.2. Discussion of the results.......................................................................77 4.1.1.2.3. Two pool kinetic model .........................................................................80 4.2. The MII Study .......................................................................................82 4.2.1. Comparison of ionic Dialysance to Reference ......................................82 4.2.1.1. Step-function momentary dialysance measurements............................82 4.2.1.2. Bolus momentary dialysance measurements........................................86 4.2.1.3. Integral Dialysis References .................................................................88 4.2.1.3.1. Single pool urea kinetic model ..............................................................88 4.2.1.3.2. Two pool kinetic model .........................................................................90 4.2.2. In vitro volume measurements..............................................................96 4.2.3. Urea Distribution Volume......................................................................99 4.2.3.1. V from direct quantification, eSPVV and 2PUKM ................................100 4.2.3.2. V from anthropometric methods..........................................................104 4.2.3.3. Conductivity based V measurements..................................................107 4.2.4 Plasma Sodium..................................................................................108 5. General discussion of the results.................................................................................110 6. Conclusions.................................................................................................................114 7. Prospect......................................................................................................................116 8. Equations and Abbreviations.......................................................................................118 9. Literature.....................................................................................................................120 10. Appendix..................................................................................................................126 10.1. The source code of the two pool calculation loop................................126 10.2. MI Study: The patient and treatment parameter details.......................131 10.3. MII Study: The patient and treatment parameter details......................133 10.4. Declaration of Helsinki........................................................................136 10.5. Statistics.............................................................................................139 11. Acknowledgements..................................................................................................141 12. English abstract .......................................................................................................142 13. Deutsche Zusammenfassung ..................................................................................144 14. Ehrenwrtliche Erklrung.........................................................................................147 15. CV ...........................................................................................................................148 16. Verffentlichungen des Autors .................................................................................150 17. Betreuende Hochschullehrer....................................................................................