TCV
TCV
h i g h l i g h t s
Over the past decade, dialyzer reprocessing machines have replaced human labor and time spent in preparing re-usable dialyzers.
It also made the process of total cell volume (TCV) measurement become faster.
Volumetric evaluation was considered as the standard to compare with the TCV values from the reprocessing machine.
Nevertheless, there has been a lack of data on efficacy of weight evaluation on TCV by machine compared to volume evaluation by the conventional
method.
The aim of study was to evaluate the efficacy of TCV measurement performed by the reprocessing machine compared to that of the conventional
method.
a r t i c l e i n f o a b s t r a c t
Article history: Introduction: Dialyzer reprocessing machines have replaced human labor in preparing re-usable di-
Received 8 January 2017 alyzers. It also made the process of total cell volume (TCV) measurement become faster. Nevertheless,
Received in revised form there has been a lack of data on efficacy of weight evaluation on TCV by machine compared to volume
23 April 2017
evaluation by the conventional method. The aim of this study was to evaluate the efficacy of TCV
Accepted 30 April 2017
measurement performed by Kidney-Kleen® reprocessing machine, produced by MEDITOP Company in
Thailand, compared to that of the conventional method.
Keywords:
Methods: This prospective cohort study was performed during September 2014 to December 2015.The
TCV
Reused
low-flux (N ¼ 101) and high-flux dialyzers (N ¼ 100) were included for TCV evaluation. Reused times
Dialyzer reprocessing machine were up to 5 in the low-flux and 20 in the high-flux dialyzers. The Bland Altman analysis was used to
Weight evaluation of TCV evaluate value measured by different methods.
Results: The values measured by weight evaluation (by machine) were higher than those obtained by
volumetric evaluation of the conventional method in the low-flux (0.81 ± 0.20%) and high-flux
(1.32 ± 0.39%) dialyzers. The correlation of TCV values of the two methods were r ¼ 0.98, p < 0.001
and r ¼ 0.71, p < 0.001 for the low- and high-flux dialyzers. Moreover, there was robust association and
agreement between the two methods, confirmed by the Bland-Altman Analysis, which suggested that
the values acquired by machine were within the limits of agreement, indicating acceptable accuracy of
equipment.
Conclusion: The approach of measurement differed from that of the conventional method (weight
evaluation was used instead of volumetric evaluation), the reprocessing machine could offer accurate
results.
© 2017 The Author(s). Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
* Corresponding author.
E-mail address: [email protected] (C. Kreepala).
http://dx.doi.org/10.1016/j.amsu.2017.04.019
2049-0801/© 2017 The Author(s). Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23 17
Fig. 1. A; Conventional method (volumetric evaluation): a dialysis nurse filled up RO water into blood and dialysate compartments to expel air within a dialyzer. Then an air pump
pressured water from the blood compartment into a cylinder. The nurse assessed a volume at the lowest point of fluid curve (lower meniscus).The volume was measured inde-
pendently by two nurses and the values were pooled together to find average TCV values. B; Automated machine method (weight evaluation): RO water flew through a water inlet
and went into a blood compartment (indicated by black arrows). Both water and air were then removed out of the dialyzer through the waste line. Later, the machine evacuated
water in the blood compartment by generating negative pressure, making water flow out of the dialyzer and flow into a measure tank (depicted by green arrows). The measure tank
then measured water weight and translated it into volume.
2.5. Statistical analysis selection algorithms between continuous variables and ordinal
variables were tested with the Spearman correlations coefficient.
Data analyses were performed by using R software (version The Bland Altman plot was employed to evaluate the agreement of
3.2.1).Continuous variables were presented as means ± standard the two measurement techniques.The 95% limits of agreement of
deviations; categorical variables were presented as percentages. Bland Altman plot (d) was calculated by d ± 1.96 ¼ mean difference
Differences between groups of patients were compared with the ±(1.96 standard deviation of the difference) [21] and p-values
Pearson chi square test for categorical variables and with the 2- 0.05 were considered statistically significant.
tailed student's T -test for continuous variables. The correlation of The risk of committing a type II error was accepted only less
C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23 19
than 5%. Hence, the result of the conventional TCV evaluation Agreement bias might occur when the same object (a dialyzer)
method would be discarded if the values between 2 dialysis nurses is measured by different methods. Though the different methods
were different >5%. The sample size was analyzed for the paired yield results in the same direction, it is hard to evaluate true effi-
sample T test. N ¼ 4(SD2/d2) with 95% confidence [22], when cacy of each method. Hence, the Bland Altman analysis was used to
N ¼ sample size, SD ¼ standard deviation and d ¼ mean of differ- eliminate such bias in this study where the performance of the
ence. The previous observational data from the center showed same dialyzer was measured by different methods.
SD ¼ 1.6% with d ¼ 4.2% and SD ¼ 2.0% with d ¼ 5.7% for the low- We used the TCV values from conventional method as a refer-
flux and high-flux dialyzers. Subsequently, the minimal estimate ence. The different values between the two methods were calcu-
sample size was calculated, yielding requirements of 56 and 66 of lated for each dialyzer for each time of reuse. The results showed
TCV evaluation for the low-flux and high-flux dialyzers, respec- that all values of the mean TCV evaluated the weights obtained by
tively. We finally decided to include the 100 samples of each item to machine, both in the low-flux and high-flux dialyzers, were higher
the accuracy of our study. than the volumes measured by the conventional method, causing
different TCV values to become negative. We then calculated the
3. Results mean of different values of TCV in the same time of reused which
were called “the mean difference”. We obtained 5 mean difference
3.1. Patient demographic data TCV values of the low-flux dialyzers (N ¼ 101) and 20 mean dif-
ference TCV values of the high-flux dialyzers (N ¼ 100) from 5 to 20
We evaluated TCV from total 201 reused dialyzers of two reused time, respectively. Consequently, the mean difference TCV
different techniques of evaluation (conventional vs. machine) from values were plotted and analyzed by the Bland Altman analysis to
51 patients. Forty one patients (male 54.9% with age average figure out an agreement interval as shown in Figs. 2e4.
(mean ± standard deviation) 60.9 ± 18.9 years) were diagnosed
with acute kidney injury (AKI) or AKI on top of advanced chronic 3.3. The TCV agreement in low-flux dialyzers
kidney disease (CKD stage 3e4), receiving acute dialysis with a low-
flux dialyzer (N ¼ 101) and 10 patients (male 60.0% with age The mean different values and percentages of mean different of
average 60.5 ± 8.0 years) were diagnosed end-stage renal disease the reused TCV low-flux dialyzers measured by the 2 methods were
(ESRD; CKD stage 5) receiving chronic dialysis with a high-flux illustrated in Table 2. There was a significant correlation between
dialyzer (N ¼ 100). Causes of AKI/ESRD as well as indication of conventional and machine evaluations in term of the values
dialysis were shown in Table 1. The average (mean ± standard de- measured (r ¼ 0.98, p < 0.001). The Bland-Altman plot, shown in
viation) reused times were 3.2 ± 1.7 times/dialyzer and 12.0 ± 5.0 Fig. 2, indicated good distribution of values and the limits of
times/dialyzer for the low-flux and high-flux dialyzer machines, agreement was valid. The plot also demonstrated the average of
with the total reused times up to 5 times and 20 times, respectively. mean difference value which was 0.71, with a lower limit of 1.05
and an upper limit of 3.63. All of the mean difference values were
3.2. The agreement analysis in the limits of agreement. The average of percentage error (percent
of the difference of mean) after reuse times up to 5 times was
The purpose of this study was to compare the efficacy of TCV 0.81± 0.20% in case of the low-flux dialyzers (Table 2).
measurement by weight evaluation by using the automated
reprocessing machines compared to that of volumetric evaluation 3.4. TCV agreement in high-flux dialyzers
by using conventional technique. Each dialyzer needed to be
measured TCV twice by the two methods. To avoid interference Similar to the agreement in the low-flux dialyzers, the Bland-
with quality of dialysis membrane, we measured TCV by machine Altman plot also showed an average mean difference value
before measuring it by the conventional method for comparison. of 1.67 with the limit of agreement possessing a lower limit
Table 1
Patient demographic data.
Abbreviations; AKI ¼ acute kidney injury, ESRD ¼ end stage renal disease, CKD ¼ chronic kidney disease, SD ¼ standard deviation, K ¼ potassium, mEq/
L ¼ milliequivalent per litre.
20 C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23
Fig. 3. The Bland Altman plots show the mean difference of TCV (each black ball) of
high-flux dialyzers between volumetric and weighing evaluation. The average of mean
Fig. 2. The Bland Altman plots show the mean difference of TCV (each black ball) of difference was 1.67 (lower limit as 2.95, and upper limit as 0.38). All values of the
low-flux dialyzers between volumetric and weighing evaluation. The average of mean mean difference (each black ball) were placed in the limits of agreement which
difference was 0.71 (lower limits as 1.05 and upper limit as 3.63). All values of the indicated good correlation between the methods to evaluate TCV in high-flux
mean difference (each black ball) were placed in the limits of agreement, which dialyzers.
indicated positive correlation between methods to evaluate TCV in low-flux dialyzers.
Reuse of the high-flux dialyzers up to 20 times could decrease Reprocessing dialyzer machines have been used widely for
membrane performance, affecting correlation in the Bland-Altman several advantages. The accuracy of TCV measurement by machine
Analysis. Thus, we divided the period of use into 1e5, 6e10, 11e15, using weight evaluation compared to that of the conventional
and 16e20 reused times and made a further analysis to figure out method using volume evaluation was confirmed by the results of
agreement among all periods in order to minimize confounding present study. Though the TCV values of the automated machine
effects of the decline in membrane performance after reuse. Results were higher than those of the conventional method, the debris or
were reported in Table 4 and Fig. 4AeD. particles in the patient's blood may have interfered with the load
The subsequent agreement analysis showed that all the mean cell sensor, increasing the weight of fluid measured. The TCV values
different values were in the limit of agreement as 1.95 (limit obtained by the two approaches showed positive correlation and
as 2.36 to 1.53), 0.96 (limit as 2.93 to 1.00), 0.96 (limit significant agreement when analyzed by the Bland-Altman
Table 2
The different TCV values of low-flux dialyzers between reprocessing machine and conventional method.
Reused time Conventional TCV (mL) Machine TCV (mL) Mean of TCV (mL) Mean difference of TCVd (mL) Percent of the difference of mean (%)
0 92
d 0.71 0.81
SD 0.18 0.20
The limits of agreement 1.05 to 3.63
Pearson correlation R ¼ 0.98*
Symbols: d ¼ mean of difference, * ¼ statistically significant (p < 0.001), d ¼ direction of difference (The minus values suggest that the values measured by machine were
higher than those obtained by the conventional method.).
Abbreviations; TCV ¼ total cell volume, SD ¼ standard deviation, mL ¼ milliliter.
C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23 21
Table 3
The different TCV values of high-flux dialyzers between reprocessing machine and conventional method.
Reused time Conventional TCV Machine TCV Mean of TCV Mean difference of TCVd (mL) Percent of the difference of mean (%)
(mL) (mL) (mL)
0 124
d 1.67 1.32
SD 0.66 0.39
The limits of agreement 2.95 to 0.38
Pearson correlation R ¼ 0.71*
Symbols: d ¼ mean of difference, * ¼ statistically significant (p < 0.001), d ¼ direction of difference (The minus values suggest that the values measured by machine were
higher than those obtained by the conventional method.).
Abbreviations; TCV ¼ total cell volume, SD ¼ standard deviation, mL ¼ milliliter.
Table 4
Summary of the mean differences of reused time for each period of high-flux dialyzers.
Mean of differencesd SD The percent of mean different (% ± SD)d Lower limit Upper limit
Symbols: d ¼ Direction of difference (The minus values suggest that the values measured by machine were higher than those obtained by the conventional method.).
Abbreviations; SD ¼ standard deviation.
22 C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23
Fig. 4. The Bland Altman plots show results in each period of reused time of high-flux dialyzers. Black balls represent the mean difference of TCV in each time of reuse. This
subsequent Bland Altman analysis has been done for A) 1e5, B) 6e10, C) 11e15, and D) 16e20 reused times. The values of mean difference (each black ball) were placed in the limits
of agreement which indicate good correlation between the methods in high-flux dialyzers.
to remove waste products from patients. conclusion, the accuracy of TCV measurement by machine using
Our study is the first to compare the efficacy of TCV measure- weight evaluation compared to that of the conventional method
ment of weight evaluation by machine compared to that of volu- using volume evaluation was confirmed by the results of present
metric evaluation by the conventional method. The results from the study. Hence, TCV measurement by machine could be used with
two methods were comparable and showed positive correlation. confidence to replace the conventional TCV evaluation in order to
The development of any automated machine evaluating TCV should reduce workload and time, as well as to provide better care for
use the range of acceptable error of not more than 1% in case of low- patients undergoing hemodialysis.
flux dialyzers, and not more than 2% in case of high-flux dialyzers. It
is because our results demonstrated the average of percentage er- Ethical approval
ror of 0.81± 0.20% and 1.32 ± 0.39% in the two types of dialyzers,
respectively and our results were into the limits of agreement. In The protocol and patient's participation were approved by the
C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23 23