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OnLine Clearance Monitor-5008 PDF
OnLine Clearance Monitor-5008 PDF
1. Foreword 4
2. Dialysis dose 5
2.1 Standard methods of determination of the dialysis dose 5
2.1.1 Urea Reduction Ratio (URR) 5
2.1.2 Kt/V 5
Clearance K
Effective treatment time t
Urea distribution volume V
2.1.2.1 Determination of Kt/V using blood samples 7
Formal urea kinetic modelling
Single-pool Kt/V (Daugirdas formula)
Single-pool variable-volume Kt/V
Double-pool Kt/V (dpKt/V) and its approximation:
Equilibrated Kt/V (eKt/V)
2.2 The clinical relevance of dialysis dose 10
2.3 Recommendations for dialysis dose and the frequency 11
of measurement of delivered dose
7. References 26
3
1. Foreword
Online Clearance Monitoring (OCM®) is a standard feature of the Fresenius Medical Care Therapy System 5008
that provides an automatic intradialytic measurement of the effective in-vivo urea clearance K, the total cleared
blood water volume Kt, the delivered dose of dialysis Kt/V and the plasma sodium concentration of the patient.
With the OCM® it is possible to easily monitor these essential parameters without additional costs during regular
ONLINE Haemodiafiltration in either pre- or post-dilution mode, and during haemodialysis treatments.
The OCM® helps physicians and nursing staff to ensure and document on a regular basis that the renal replace-
ment therapy meets the recommended or required quality standards without the need for additional laboratory
tests or expenses.
This user brochure provides clinical and technical background information on the OCM®, describes its operation
and gives recommendations for the application of the OCM®.
4
2. Dialysis dose
Similar to the term “dose”, that defines the specific Ultrafiltration leads to a very efficient transfer of urea
quantity of a medical product or drug required for the from the blood into the dialysate, but this does not
treatment of a patient, the dialysis dose can be defined result in a direct reduction of the urea concentration in
as the quantity of dialysis treatment delivered for a the blood. This removal of urea is not accounted for in
given period of time. In general the dialysis dose is the URR method. The greater the UF volume removed
measured by the comparison between the baseline and during dialysis, the more inaccurate the results of
final concentration of a defined substance in the blood dialysis dose calculation based on URR (2,3).
of the patient. The more efficient the dialysis session,
the greater the reduction of this given substance is.
2.1.2 Kt/V
In theory, it is possible to determine how efficient any
substance which is present in the blood has been re-
moved during dialysis. Even though different methods Clearance Dialysis time
(Manufacturer) (Nephrologist)
have been developed to measure the dialysis dose, K x t
changes in urea concentration are monitored in order
to determine the dialysis dose in standard practice. V
Distribution volume
(Patient)
2.1 Standard methods of determination
of the dialysis dose 41: The variables of the Kt/V formula
5
In-vivo must be differentiated from effects of the corpuscular blood constituents (mainly
in-vitro clearance: the erythrocytes), the dissolved plasma proteins, and the
adsorption of plasma proteins on the dialysis mem-
In-vitro clearance represents the purely diffusive clearance brane (the “secondary membrane”) considerably alters
achieved by a dialyser tested under defined conditions the diffusion properties of the dialysis membrane even
(as specified in standard EN 1283) using standardised under otherwise comparable circumstances.
aqueous solutions. The EN 1283 standard requires that
measurements be conducted at a predefined dialysis In-vivo clearance is thus inevitably lower than the stan-
fluid flow rate without any ultrafiltration (that is, without dardised in-vitro clearance, but does reflect the actual
a convective clearance component). Only on the basis conditions of the treatment and is thus of central impor-
of these non-patient-specific laboratory measurements tance for the determination of dialysis efficiency.
is it possible to compare clearance values and thus the
relative efficiency of individual dialysers. In-vitro clear-
ance, i. e. the efficacy of a dialyser under laboratory CB in – CB out
K = QB
conditions, is thus primarily determined by the design CB in
features of the dialyser as well as the membrane char-
K = clearance (mL/min), QB = effective blood flow (mL/min), CB in = concentration
acteristics. of inflowing blood, CB out = concentration of outflowing blood
In-vivo Clearance K
influenced by: dialyser, effective
blood (water) flow (considering
haematocrit), ultrafiltration,
recirculation, dialysis fluid flow
Effective dialysis time t
sometimes reduced due to alarms
and bypass conditions or premature
termination of the treatment
6
reasons are considered in the effective dialysis time The following examples should help explain the
42. The effective dialysis time is, in most cases, use of the Kt/V concept:
shorter than the total duration of treatment provided.
Assuming Kt is 20 litres, this means that 20 L of blood
In an observational study, Segura et al. have demon- have left the dialyser after being cleared of urea. How-
strated that the mean prescribed duration of dialysis ever, this information does not yet tell us which dialysis
is generally not achieved in practice. Thus, over the dose the patient has received. In the case of a patient
period of 1 year, the loss of time and therefore of with a urea distribution volume V of 30 L, a cleared
efficiency per patient was equivalent to that of 7 whole blood volume of 20 L has quite a different meaning
dialysis sessions (4). than in the case of a patient with a urea distribution vol-
ume of 40 L. If Kt/V is equal to 1, this means that the
volume of blood which has been completely cleared
Urea distribution volume V of urea in the dialyser is exactly equivalent to the urea
distribution volume of the patient. In a patient with a
The urea distribution volume V is equivalent to the total distribution volume of 40 L, Kt must be equal to 40 L
body fluid, consisting of the proportion of water in blood so that the result of the formula Kt/V is also 1. If the Kt
(7 %) as well as the interstitial (31 %) and intracellular value is only 20 L, the Kt/V value would be 0.5.
volume compartments (60 %). Upon commencement of
dialysis, urea is homogeneously distributed throughout Even if Kt/V is equal to 1, this does not mean that the
the body; hence, more than 90 % of the urea which total body fluid or the total urea distribution volume
accumulates in the human body is not present in blood, of the patient is free of urea, but only that, using the
but in the interstitial and intracellular volume compart- example above, 40 L blood have left the dialyser after
ments. Thus, only with continuous diffusion of urea being freed of urea. If Kt/V is 1.0, a urea concentration
from these compartments into the blood and further of approximately 36 – 37 %, relative to the baseline
transport into the extracorporeal circulation is the value, remains after dialysis.
largest proportion of urea present in the body made
available for dialysis.
2.1.2.1 Determination of Kt/V
The larger the blood volume (high blood flow rate) which using blood samples
reaches the dialyser during a treatment session and
the longer the duration of the time-dependent diffusion There are various methods which can be used to de-
from the interstitial and intercellular compartments into termine Kt/V in practice. These differ in terms of the
the blood (adequate treatment time), the more efficient underlying mathematical models used to predict and
the dialysis treatment will be. determine urea kinetics (in other words, the changes in
the blood urea concentration of the patient over time).
A major advantage of the Kt/V equation is the fact that Some methods involve very complex calculations and
it takes into account the individual body weight of the require appropriate software programmes.
dialysis patient. Patients with the same Kt/V are detoxified
to the same extent even if they have markedly different
body weights. Dialysis treatments can thus be compared
in terms of the elimination effect using the Kt/V method.
7
Formal urea kinetic modelling Single-pool Kt/V (Daugirdas formula)
The most complex, but at the same time most precise The best alternative to the urea kinetic modelling
method of determination of Kt/V is the so-called for- method, also based on analysis of blood samples,
mal urea kinetic modelling (5,6). This requires accurate is provided by the formula for the calculation of Kt/V
measurement of: developed by J.T. Daugirdas (8).
The main disadvantage of the urea kinetic modelling ECV: Extracellular volume
Time [min]
More recently, a two point urea kinetic model has been
End of treatment
validated which is based on only two measurements
43: Blood urea nitrogen concentration at the beginning (1), at the end (2)
of urea or BUN instead of three, prior to and after the and 60 minutes after the end (3) of a HD treatment
8
Double-pool Kt/V (dpKt/V) and its approximation: with low urea concentrations but having higher rates
equilibrated Kt/V (eKt/V) of blood perfusion. Organs with low blood perfusion
therefore also constitute a further urea reservoir. In the
As in the case of the other (not discussed here) single- initial 30 minutes after completion of dialysis, the
pool models, the Daugirdas formula considers the concentration equilibration again leads to a rebound,
body, for the purposes of mathematical modelling as thus an increase in blood urea concentration.
a single unified fluid pool, and does not take into
account the differences in rates of urea transfer The extent of total urea rebound can differ greatly
between the three fluid compartments blood plas- between individual patients. In a study conducted by
ma, extracellular space and intracellular space. This Leblanc et al. (15), the mean rebound, the percentage
difference in the transfer rate of urea is described as increase in postdialytic urea concentration 30 minutes
the double-pool effect. after dialysis, in comparison with that immediately
after completion of dialysis, was 17 %.
With increasing efficiency of the dialyser, it is possible
that urea is eliminated more rapidly from the blood than If this rebound effect is taken into account in the cal-
it can diffuse from the cells into the blood. Due to this culation of the dialysis dose, the resultant Kt/V value is
relative delay of urea movement from cells into blood, referred to as equilibrated Kt/V (abbreviated to eKt/V).
the intracellular compartment becomes a non-equilib- On average, equilibrated single-pool Kt/V (eKt/V) is 0.2
rated reservoir for urea, and this aspect is not taken into lower than non-equilibrated single-pool Kt/V (17,18).
account in the single-pool models for urea kinetics (9,12,13).
Hence, on completion of a dialysis treatment, the intra- In order to obtain an exact value for equilibrated Kt/V,
cellular urea concentration is greater than in blood the BUN concentration should ideally be measured 30
plasma, and the diffusion of urea from cells into blood minutes after completion of dialysis, but this is, un-
nevertheless continues for approximately 30 – 60 fortunately, not practicable in routine practices of out-
minutes after the end of treatment43. This phenom- patient haemodialysis centres. In order to overcome
enon is called urea rebound (14,15). If this intracellular this problem, various formulae have been developed
urea pool is large on completion of dialysis and is not which, after a third blood (urea) sample has been taken
taken into account, the effective dialysis dose Kt/V will during the dialysis session (usually after 70 minutes
be overestimated. This effect is particularly marked if dialysis), allow the postdialytic equilibrated urea con-
high performance dialysers are used in combination centration to be approximatively calculated (16,19). The
with a short duration of dialysis (16). additional effort required to obtain a third blood (urea)
sample has meant that this method has not been
In addition to the relative delay of transfer of urea widely accepted.
between the various body compartments, the marked
differences in blood perfusion of organs also contribute Daugirdas has also developed a formula which allows
to the rebound effect. It should be borne in mind that the results of calculation of single-pool Kt/V to be extra-
70 % of total body water, and thus also urea, is present polated to equilibrated Kt/V (20). Formula 1 ( artKt/V) is
in body organs with a relatively low blood perfusion, applicable if an arterial postdialytic urea value from
such as skin and muscles at rest. As these urea-rich an arterio-venous access is available, while formula 2
organs have only a relatively low blood flow, their con- ( venKt/V) should be used if a mixed venous urea value
tribution to the total plasma urea which reaches the from a veno-venous access is available:
extracorporeal circulation is less than that of organs
9
(1) equilibrated or eKt/V = artKt/Vsp – (0.6 x artKt/Vsp/T) + 0.03
In 2002, Port et al. published an observational study
(2) equilibrated or eKt/V = venKt/Vsp – (0.47 x venKt/Vsp/T) + 0.02 of major importance on the effect of delivered dialysis
dose on the risk of mortality (31).
T: dialysis treatment time in hours, t: dialysis time in minutes
* *
*
* * Small
Table 1: Ratio of single-pool Kt/V (spKt/V) and equilibrated Kt/V (eKt/V) *
as a function of treatment time (t) * * Medium
Small BMI < 23.2 kg/m 2
spKTt/V 2.0 hrs 2.5 hrs 3.0 hrs 3.5 hrs 4.0 hrs 4.5 hrs 5.0 hrs
1.0 0.73 0.79 0.83 0.86 0.88 0.90 0.91
1.1 0.80 0.87 0.91 0.94 0.97 0.98 1.00
* p<0.05 compared to next lower URR group
1.2 0.87 0.94 0.99 1.02 1.05 1.07 1.09
1.3 0.94 1.02 1.07 1.11 1.14 1.16 1.17 44: Dialysis dose and body mass index are strongly associated with survival
1.4 1.01 1.09 1.15 1.19 1.22 1.24 1.26 in haemodialysis patients. Retrospective analysis of data from 45.967 US
1.5 1.08 1.17 1.23 1.27 1.31 1.33 1.35 hemodialysis patients starting dialysis during April 1997 through December
1998 (adapted from (31)).
1.6 1.15 1.25 1.31 1.36 1.39 1.42 1.44
10
was compared (32). Measured haematocrit was identi- consensus on best practices and dialysis adequacy
cal, at 35 ± 1.5 %, in the two investigated groups, A amongst the European nephrological community (67).
and B, although group A received dialysis at a low Kt/V
<1.2 and group B received dialysis at a high Kt/V >1.4 The respective recommendations regarding dia-
45. While group A (Kt/V<1.2) had an EPO requirement lysis dose are specified as follows:
of 183 ± 95 U/kg/week, patient group B with its high
Kt/V (>1.4) required only 86 ± 33 U/kg/week. This • The delivered dialysis dose should be regularly
study shows that if a sufficiently high dialysis dose is measured and monitored – at least monthly using a
delivered, this can have a positive effect on the overall standardised method
clinical condition of the patient, which, in turn, is re- • The delivered dialysis dose should be expressed as
flected in a reduction of the EPO requirement. equilibrated Kt/V (eKt/V) or as single-pool Kt/V (spKt/V)
• The minimum dose per session on a thrice-weekly
schedule should be eKt/V ≥ 1.20 (spKt/V ~ 1.4)
EPO dose [U/kg/week]
Group A
Hct: 35%
The EBPG for Haemodialysis are considered to be the
reference guidelines in Europe and have been adop-
ted or taken as the basis for the preparation of national
Group B
Hct: 35% guidelines.
11
3. Online Clearance Monitoring – OCM®
12
Blood outflow Dialysis fluid inflow This short-term increase in the conductivity of the dia-
13
clearance were exactly identical, all results would be ports recirculating sodium ions to the dialyser which,
on the ideal line). The majority of values are within an depending on the concentration in the blood, will diffuse
error range of only ± 5 – 6 %. back into the dialysate. Consequently this results in a
less favourable ratio of the areas under the conductivity
Through further improvements of the Online Clearance curves, and thus to a reduction in clearance equivalent
Monitoring® method, Goldau et al. reported in a further to the contribution made by recirculation. Although it is
series of analysis in 2002 an improved level of precision not possible to produce actual figures for recirculation
of below the 5 % error limit (45). from the OCM®, the effect is taken into account in the
calculation of effective in-vivo clearance.
With this comparatively short (but still sufficiently long) On the basis of the two measured parameters – urea
measurement of dialysate conductivity at the dialyser clearance and effective dialysis time – the OCM®
outflow, not only the sodium dialysance of the dialyser, calculates the cumulative water volume contained
but also the negative effects of total recirculation (fis- within the blood K x t (in litres) which has been cleared
tula recirculation plus cardiopulmonary recirculation) of urea, which is equivalent to that proportion of the
can be determined48. Even after the conductivity pulse circulating blood from which all urea has been re-
in the dialysate has faded out, recirculating blood trans- moved during dialysis: K x t = x (L).
14
In order that the Kt/V value can be determined by di-
vision of the result for K x t by the urea distribution
volume V, the operator must enter an appropriate va-
lue for the urea distribution volume V of the individual
dialysis patient.
V
Normally unknown
V from anthropometric data (Watson,Hume-Weyers ...),large deviations 411: A calculator to estimate the urea distribution volume V according to
lead to an approximate Kt/V anthropometric formulae is integrated in the OCM®
V from a previous Urea Kinetic Modelling procedure (DCTool ), leads to
the best results for Kt/V (± 0.1 Kt/V)
V from other methods, e.g. bioimpedance
410: To calculate the Kt/V the OCM® measures K and the 5008 Therapy It is not only possible to derive the V of a patient by
System measures the exact effective dialysis time t; the user has to enter the
patient’s V calculation, but this parameter can also be precisely
measured. In clinical routine, the bioimpedance
spectroscopy technique or the urea kinetic modelling
The easiest method of estimating urea distribution method described in section 2 above can be used.
volume V is to use the anthropometric formulae de- Once this measured value is available, it can be directly
veloped by Watson (48), Hume-Weyers (49) and Mellits- entered into the data-entry menu of the OCM®: the
Cheek (70), the latter being especially adapted for information necessary for the anthropometric formulae
children below the age of 16. All formulae can be (age, gender, etc.) is then, of course, no longer required.
selected in the OCM® menu of the 5008. The Watson
formula calculates the V of a patient on the basis of The anthropometric formulae allow V to be simply and
body weight, height, age and gender411. quickly estimated, but the results represent only a stan-
dardised mean value for the population as a whole.
Deviations attributable to individual factors, such as an
Male above-average proportion of fat or muscle tissue, are
Vurea = 2.447 - 0.09516 x age + 0.1074 x height + 0.3362 x weight
not accounted for. In some cases, there may be marked
Female differences between the value for V calculated using
Vurea = -2.097 + 0.1069 x height + 0.2466 x weight
the Watson formula and the measured value for V.
15
In order to determine an exact value for spKt/V using urea profile of a haemodialysis patient based on two
the OCM®, it is always preferable to enter the measured blood samples (pre and postdialytic) using the sing-
urea distribution volume rather than an anthropomet- le-pool variable volume method (7). Important data
rically-derived V. relevant to the dialysis and nutritional status of the
patient, such as urea distribution volume, Kt/V and
protein catabolic rate (PCR) are derived from this. The
DCTool programme differs from the standard urea
kinetic programmes in that, instead of calculating theo-
retical clearance on the basis of blood and dialysate
flow rates, the effective in-vivo clearance – averaged
for the treatment as a whole – as measured by the
OCM® is used for modelling.
Blood samples (expensive) Kt/V ≥ 1.2... 1.8 Dialysate; K and t (no additional costs)
Once a month/quarterly Frequency In every session
Retrospective Control Continuous, online
Staff, syringes, lab time, cost and energy Effort None
6–8% Accuracy of K 6%
Inconvenient Handling Automatic
Unpractical and uncommon Quality assurance Standard!
413: OCM® offers many advantages in comparison with the conventional method for the Kt/V measurement
16
ger time period (up to 6 months for stable patients) (66).
It is possible to convert this single-pool Kt/V determined
by the OCM® to an eKt/V (≈ double pool Kt/V) using
the formulae provided in section 2.1. Alternatively,
eKt/V values are also shown in the table 1 on page 10.
In order to ensure that the V value is appropriately
updated, it is advisable to repeat urea kinetic model- 414: The OCM® display: The blue line indicates the urea clearance, the
cumulating Kt/V is displayed by the red line, the Goal-Kt/V is visualised as a
ling calculations with DCTool within the framework of green line.
In clinical studies in which 40 treatments and 151 treat- haemodialysis in the removal of middle molecules. In
ments were analysed, it was shown that the DCTool- selected European countries, up to 30 – 40 % of the
method provided the optimum value for the urea distri- dialysis population is treated with ONLINE HDF, the
bution volume of a patient (51,52,66) and that the results average however being around 10 % (61).
agree well with the total body water measured with
bioimpedance spectroscopy. Several studies have demonstrated clinical advan-
tages of the ONLINE HDF treatment modality such as
The use of the OCM® functionality and DCTool in an increased dose of dialysis, a reduced risk of ß2-
combination makes it possible to determine the exact microglobulin-associated amyloidosis (62,63), a positive
value for spKt/V during each routine dialysis. influence on the treatment of anaemia (64) and im-
proved intradialytic cardiovascular stability (65). The
The parameters relevant to therapy monitoring, includ- results of two recent studies even demonstrate that
ing the OCM® measurement results, are displayed patients treated with ONLINE HDF had a significant
in a clear overview with a multi-coloured diagram on 35 % reduction of mortality risk compared to patients
the touch screen of the 5008 Therapy System. The treated with standard haemodialysis (68,69).
clearance K is displayed during the course of the
treatment as a blue line in the “OCM® diagram” graphic, The precision of the OCM® clearance measurement
so are the current and absolute values for K, Kt/V or under ONLINE HDF conditions has been validated
Kt and Goal-Kt/V. In addition, the cumulative Kt/V (red in-vitro and in clinical experiments by Canaud et al.
line) or Kt (black line) are visualised in relation to the set (Hôpital Lapeyronie, Montpellier, France; publication in
Kt/V target (green line). KI pending (71)). In these investigations, an error range
of 6 % for the clearance measurement of the OCM®
system during ONLINEplus HDF was reported.
3.2 OCM in ONLINEplus Haemodiafiltra-
®
17
4. Optimisation of dialysis efficiency
The efficiency of each haemodialysis treatment is determined by the following four parameters:
It is essential to achieve the appropriate balance of these parameters in order to ensure that adequate dialysis treat-
ment is provided and also to ensure that the resources available are economically utilised.
Dialysate flow 500 mL/min When prescribing the required blood flow, and par-
ticularly when increasing blood flow, the individual
Urea clearance [mL/min]
18
Since the OCM® conducts the clearance measure- 4.2 Dialysis time
ment on the dialysate side only, the accuracy of K is
not influenced by deviations in the blood flow rate. In As the dialysis time t is a direct variable in the Kt/V
the case of blood or dialysate flow changes in between formula, it is important to ensure that a sufficiently long
two subsequent measurements, the OCM® is able to effective dialysis time is delivered to ensure provision of
account for these changes by using a mathematical an adequate dialysis dose. It is essential to prescribe
estimate for K under the new conditions. a sufficiently long treatment time which, by avoiding
all interruptions caused by alarms or other delays,
should, as far as possible, also represent the effective
dialysis time.
19
4.3 Dialyser 4.4 Dialysate flow rate
(Membrane surface area, low flux/high flux)
It is the concentration gradient between the blood and
240 dialysate which mainly determines the diffusion rate
230
during haemodialysis. The larger the flow of fresh, toxin-
free dialysis fluid through the dialyser, the larger the
220
Urea clearance [mL/min]
170
0,6 0,8 1,0 1,2 1,4 1,6 1,8 2,0 2,2 2,4
Effective dialyser surface [m2]
FX-class high flux range
FX-class low flux range
416: Urea clearance of Fresenius Medical Care low and high flux dialysers
as function of the effective surface
20
The prerequisite for an effective dialysis treatment is
an appropriate balance between blood flow rate, dia-
lysate flow rate, treatment time and the dialyser used.
418: The CCT Clearance Calculation Tool is a software for the planning of
haemodialysis treatments. CCT allows a clearance estimation of any Fresenius
Medical Care dialyser over the full range of treatment conditions
21
5. Measurement of plasma sodium with the OCM®
In addition to the delivered dialysis dose, the OCM® also Various studies have demonstrated that restriction of
measures the level of plasma sodium of the patient. sodium intake has a favourable effect on long term
This information is a useful aid in the appropriate blood pressure control in dialysis patients; low sodium
therapeutic adjustment of the sodium concentration content in the dialysate, provided this is tolerated by
of the dialysis fluid to the individual plasma sodium the patient, can assist in dietary control of sodium in-
level of the patient. take (57 – 59). Krautzig et al. have demonstrated that with
low sodium intake, it is possible to reduce, or even dis-
In a clinically stable haemodialysis patient, there is continue, the use of anti-hypertensive medication (60).
physiological equilibrium between the quantity of salt
ingested with the nutrition and the quantity of NaCl However, if a dialysate with a non-physiological, low
removed during haemodialysis. sodium concentration is used, this can frequently
trigger intolerance reactions, such as hypotension,
There are two mechanisms of intradialytic removal of tiredness and cramps.
NaCl: ultrafiltration (UF) and diffusion.
Conversely, the use of a dialysate with a non-physio-
The electrolyte composition of the ultrafiltrate removed logical, high concentration of sodium may improve
for the purposes of dehydration of the patient is very blood pressure stability during dialysis, but also in-
similar to that of blood plasma, the NaCl concentration creases the patient’s thirst and results in a subsequent
in the ultrafiltrate varies from patient to patient in the increase in fluid intake by the patient. This, in its
approximate range 135 – 140 mmol/L. The quantity of turn, leads to increased overhydration and long-term
NaCl removed during ultrafiltration depends directly on hypertension in the patient. Figure 20 summarises
the volume of UF removed; the higher the volume of UF, the advantages and disadvantages of high and low
the greater the quantity of NaCl removed from the patient. sodium concentrations in the dialysate.
22
deciding on the optimum concentration of sodium in factors so that the displayed value for plasma sodium
the dialysis fluid, the nephrologist should consider the is equivalent to that obtained by means of flame pho-
predialytic plasma sodium, the general status and the tometry assay.
cardiovascular stability of the patient.
Small absolute differences between the plasma sodium
concentration determined by the dialysis machine
using this non-invasive method and the results
of laboratory analysis can be explained by deviations
Plasma-Na [mmol/l]
23
6. Frequently Asked Questions about the OCM®
1. Is Kt/V as measured by the OCM® a single-pool or of a blood flow change between 2 measurements). If an
double-pool Kt/V? estimated Hct which deviates from the actual Hct of the
patient is entered in the OCM® template, this will have
The Kt/V value determined by the OCM® is a single-pool little effect on the accuracy of the value for clearance
Kt/V (spKt/V). It is possible to convert the single-pool calculated by the OCM®. If, for example, the entered
Kt/V determined by the OCM® to an eKt/V (≈ equilibrated value for Hct is 10 % higher or lower than the actual
or double pool Kt/V) using the formulae provided in value for Hct, there is only a 2 – 3 % change in the re-
Section 2.1.2.1 Alternatively, eKt/V values are also sult for clearance. If no value for Hct is entered prior to
shown in the table on page 10. commencement of treatment, the OCM® automatically
assumes a hypothetical value of 35 %. In case a 5008
2. In a comparison conducted at a dialysis centre, it Blood Volume Monitor (BVM) is used simultaneously
was observed that the OCM® Kt/V was 10 % lower than with the OCM®, the continuously measured Hct value can
the Kt/V measured on the blood side: what is the cause be automatically transferred from the BVM to the OCM®.
of this discrepancy?
4. Why is the clearance measured by the OCM® frequen-
Such a difference is frequently seen if the value for urea tly lower than clearance measured on the blood side?
distribution volume V used for Kt/V calculation by the
OCM® has been estimated using the Watson formula. This occurs if a simplified method of whole blood
The anthropometric Watson formula tends to overesti- clearance measurement is performed on the blood
mate the urea distribution volume in dialysis patients. As side, where the full blood flow value QB is used
the precisely measured result for K x t determined by for blood side calculation of clearance, while the
the OCM® is then divided by an incorrectly high value OCM® correctly uses the effective flow of water
for V, this results in an underestimation of the delivered contained within the blood (= plasma water + intra-
dialysis dose (Kt/V). This problem can be avoided if the cellular water). The effective flow of water contained
value for V is determined more precisely using a bioim- within the blood is equivalent to the effective blood
pedance spectroscopy (BIS) technique or urea kinetic flow x 0.87. The factor 0.87 takes into account the
modelling (e.g. with the aid of DCTool) – see Section characteristic composition of human blood. If the
3 – and this value being entered into the OCM® and effective flow of water contained within the blood is not
stored on the PatientCard for future use. used for blood side calculation of clearance, there can
be an inappropriate overestimation of urea clearance
3. What is the significance of haematocrit for the calcu- by up to 25 % compared with the effective clearance
lation of clearance and plasma sodium concentrations? which is accurately measured by the OCM®.
What alternative is there if no recent value for haema-
tocrit is available for a patient? Could an estimated value 5. Could the accuracy of OCM® measurements be im-
for haematocrit result in an inaccurate result for Kt/V? paired if equipment is not disinfected between each di-
alysis treatment?
The haematocrit is required to calculate the effective
flow of water contained within the blood (= plasmawa- In theory, throughout dialysis deposits may occur on
ter + intracellular water) and subsequently the effective the conductivity sensors of the OCM® just as in any of
Kt/V (Comment: Hct does not have any influence on K, the other components of the hydraulic system of a
since only dialysate-side quantities are used to deter- dialysis machine. To avoid this problem, it is mandatory
mine it. Rather, it enters the estimation formula in case to disinfect the equipment after each dialysis session.
24
The risk of an inaccurate clearance measurement is For girls with a height > 110.8 cm:
thus excluded. V = -10.313 + 0.252 x body weight (kg)
+ 0.154 x height (cm)
6. Does the accuracy of the OCM® depend on the
membrane material used in the dialyser? In order to obtain a precise value for V in children, a
bioimpedance measurement or urea kinetic modelling
No evidence has been found to date that the accuracy (e. g. with DCTool) is preferable.
of the clearance measurement by the OCM® is influ-
enced by the type of dialyser membrane used. 9. How does one take into account an amputation
when calculating urea distribution volume?
7. Can OCM® measurement be started during on-going
dialysis treatment? Urea distribution volume V in amputated dialysis pa-
tients should not be estimated using anthropometric
In principle, the OCM® can be started at any time during formulae (such as the Watson formula), but should be
on-going treatment. If, however, more than 80 minutes determined by a bioimpedance measurement or urea
have passed since treatment was started without a suc- kinetic modelling (DCTool).
cessful OCM® measurement performed, the system will
not calculate Kt and Kt/V. It would not be worthwhile ex- 10. Can OCM® also be used during ONLINE HDF?
trapolating backwards, as there may have been marked
changes in clearance since the initiation of treatment. OCM® can be used during regular ONLINEplus Haemo-
dialfitration treatments in either post- or predilution mode
8. Is it possible to calculate the urea distribution volume but due to the missing dialysate flow in the dialyser not
of children using the Watson formula? in ONLINE-HF nor in Single-Needle modes.
25
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