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TCV

Measurement accuracy of total cell volume by automated dialyzer reprocessing: A prospective cohort study
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281 views8 pages

TCV

Measurement accuracy of total cell volume by automated dialyzer reprocessing: A prospective cohort study
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Annals of Medicine and Surgery 18 (2017) 16e23

Contents lists available at ScienceDirect

Annals of Medicine and Surgery


journal homepage: www.annalsjournal.com

Measurement accuracy of total cell volume by automated dialyzer


reprocessing: A prospective cohort study
Chatchai Kreepala a, *, Aroonchai Sangpanich a, Phirudee Boonchoo b,
Warit Rungsrithananon c
a
Department of Internal Medicine, Faculty of Medicine, Srinakharinwirot University, Thailand
b
Hemodialysis Unit, HRH Princess Maha Chakri Sirindhorn Medical Center, Srinakharinwirot University, Nakornnayok, Thailand
c
Chantarubeksa Hospital, Nakornpathom, Thailand

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

1. Introduction measurement (manual method) can be cost-beneficially replaced


by the weight measurement (automated machine).
A hemodialyzer is an instrument that has been used universally
to purify fluid and waste metabolites from the blood of renal 2. Materials and methods
failure patients. Different types of dialysis membrane (flux) were
categorized by the clearance of b2 microglobulin across membrane 2.1. Clinical data collection
during hemodialysis. The dialyzers with b2 microglobulin clearance
less than 20 ml/min are called ‘low-flux dialyzer’, usually used for This prospective cohort study was performed at the hemodial-
small uremic toxin removal in acute kidney injury. Meanwhile, the ysis unit within HRH Princess Maha Chakri Sirindhorn Medical
dialyzers with b2 microglobulin clearance more than 20 ml/min are Center, Srinakharinwirot University, Thailand. Our study was con-
called ‘high-flux dialyzer’, usually used for middle molecular size ducted during September of 2014 to December of 2015. All dialysis
removal such as in setting of chronic hemodialysis for end-stage patients receiving either high or low flux dialysis during this period
renal disease patients. were informed of study, and all gave full consent to participation.
Reprocessing dialyzer machines have been used worldwide for In this study, the low-flux dialyzer, was equipped with synthetic
economic advantage [1e4], improvement in blood-dialyzer mem- polysulfone membrane with 1.5 m2 effective surface area and 90 mL
brane biocompatibility, and benefits of preventing the first-use of TCV (Diacap Polysulfone® LO PS 15 Dialyzer) and the high-flux
syndrome which is an anaphylactoid reaction to the dialysis dialyzer was synthetic polynephron membrane dialyzer with
membrane causing wide-range of symptoms including cardiac ar- effective surface area of 1.9 m2 and 115 mL of TCV (Elisio-190HR®).
rest [5e7]. The machines have helped shorten the period of The protocol and patient's participation were approved by the
cleaning, leak testing, and sterilant filling. However, there have Human Research Ethics Board of Srinakharinwirot University (Issue
been still some concerns about the use of machines such as infec- #SWUEC-X-037/2557).
tion. The Centers of Disease Control and Prevention (CDC) have The reused times were up to 5 times in the low-flux and 20
recommendations against dialyzer reuse in patients with active times in the high-flux with acute kidney injury (AKI) and end stage
bacterial and hepatitis B infection [8e11]. Decline in dialyzer per- kidney disease (ESRD), respectively. Patients with HIV, hepatitis B,
formance after reuse has also been of concern. Performance indices hepatitis C infection and suspected sepsis or bacteremia were
can be measured by two approaches, namely total cell volume excluded. All patients were dialyzed for 4 h per a dialysis session
(TCV) measurement and urea clearance evaluation. The KDOQI which was maintained by an initial loading of intravenous heparin
guidelines [1] have suggested that a dialyzer is suitable for reuse 3000 IU, followed by hourly bolus of heparin 1000 IU intravenously.
only when a TCV value is at least at 80% of the baseline or the urea Each dialyzer was reprocessed with formaldehyde 4% and reused
clearance of the dialyzer is at least at 90% of the original value again for the same patient only when TCV was 80% of the original
[12e15]. value.
TCV, one of the parameters indicating dialyzer performance
mentioned above, refers to the volume of the blood compartment 2.2. TCV evaluation
of a dialyzer. A TCV value is determined by measurement of volume
of water being filled in a blood compartment of a dialyzer either All the dialyzers were cleaned by the reprocessing machine
with the conventional method or with automated reprocessing (Kidney-Kleen®) before the measurement of TCV was performed.
machines. With the conventional approach, a dialysis nurse fills TCV was measured for the evaluation of quality of each dialyzer
reverse-osmosis (RO) water into the blood compartment of dialyzer values were calculated as a percentage ratio compared to the
and later measures the volume of water flowing out of the baseline value.
compartment equipped with an air pump. With the development
of the reprocessing machines, several hemodialysis centers have 2.3. The conventional TCV evaluation
replaced the conventional TCV evaluation with an automated
method in addition to the cleaning of dialyzer. Evaluation of TCV After the cleaning process by machine, a TCV was first measured
relies on the principle of fluid mechanics by volumetric evaluation. by machine. A dialyzer was then removed and underwent 2 sepa-
There has been an attempt to discover the best indirect approach to rate TCV conventional evaluations by 2 blinded dialysis nurses who
measure TCV in order to substitute volumetric evaluation per- have at least 5-year experience on cleaning processes of dialyzer.
formed by human such as weight measurement, hydrostatic pres- Both the dialysis nurses were blinded to the patient's clinical pre-
sure measurement, and ultrasonic detection [16e20]. sentation, any value from the machine, and the value of TCV ob-
Kidney-Kleen® employs weight measurement, one of the most tained from each other. The blood and dialysate compartment of
popular techniques, to determine TCV. Weight measurement is an the machine were filled with reverse osmosis (RO) water, and TCV
indirect approach to measure and translate weight into volume, was subsequently measured by evacuating water from the blood
based on an assumption that 1 mg of water is equal to 1 mL of compartment with an air pump. Two manual TCV values from the
water. However, several factors may have affected on the weight same dialyzer were averaged and used as its reference value for
measurement of TCV by the reprocessing machine such as space- quality evaluation and onward comparison with the value obtained
occupying air bubbles, weight of debris particles in patient's from the machine. Any dialyzer with referenced TCV of less than
blood, incomplete collection of fluid from dialyzers' membrane. By 80% of its original value was discarded (<72 mL and <92 mL for
using the automated approach, the reprocessing and the TCV low-flux and high-flux machines, respectively).
measurement are done simultaneously, and the healthcare pro-
vider may benefit from reduced human workload and shortening of 2.4. The reprocessing machine TCV evaluation
overall process time. Nevertheless, the efficacy of TCV measure-
ment by weight has not been widely studied since the main pur- Similar to the conventional TCV measurement, RO water was
pose of the reprocessing machines was to clean the dialyzer, not to filled into the blood compartment vertically from bottom to top of
measure the TCV. Therefore, this study is the first to compare the the dialyzer. Later, water was evacuated from the blood compart-
efficacy of conventional measurement and automated approach. ment into a measure tank and the weight of water was measured by
Our hypothesis is that TCV measurement from volumetric a load cell sensor as shown in Fig. 1.
18 C. Kreepala et al. / Annals of Medicine and Surgery 18 (2017) 16e23

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.

Number of Patient Number of Dialyzer

Acute dialysis with low-flux dialyzers (number) 41 101


Male 54.9%
Age (mean ± SD) 60.9 ± 18.9 years
Cause of AKI (%)
Acute Tubular Necrosis (including toxin, cardiogenic shock, etc.) 90.2
Acute glomerulonephritis 4.9
Post renal (obstructive) AKI 4.9
Indication of acute dialysis (%)
Volume overload 56.1
Uremia 39.0
Hyperkalemia (K > 5.5) 2.4
Severe metabolic acidosis (serum bicarbonate <15 mEq/L) 2.4
Chronic dialysis with high-flux dialyzers (number) 10 100
Male 60.0%
Age (mean ± SD)
60.5 ± 8.0 years
Cause of ESRD (%)
Diabetic nephropathy 80
Chronic glomerulonephropathy 10
Unknown cause of CKD 10

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.

as 1.49 to 0.44) and 1.41 (limit as 1.72 to 1.10) for 1e5,


of 2.95 and an upper limit of 0.38 (Fig. 3). There was a good 6e10, 11e15, 16e20 reused time, respectively. In addition, the dif-
correlation of TCV between two methods (r ¼ 0.71, p < 0.001), and ference mean of percent (Table 4) demonstrated the values of error
the average of percentage error (difference mean of percent) after would be similar as whole analysis as higher than that of the
reuse times up to 20 times was 1.32 ± 0.39% in case of the high-flux conventional method by 1.64 ± 0.18%, 0.82± 0.85%, 0.82 ± 0.23%,
dialyzers (Table 3 and Fig. 3). and 1.20 ± 0.14% for 1e5, 6e10, 11e15, and 16e20 reused time
analysis, respectively.

3.5. The subsequent period agreement for TCV evaluation in the


high-flux dialyzers 4. Discussion

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

1 88.77 89.48 89.13 0.71 0.80


2 88.58 89.11 88.85 0.53 0.60
3 87.27 87.93 87.60 0.66 0.75
4 86.89 87.89 87.39 1.00 1.14
5 86.79 87.43 87.11 0.64 0.73

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

1 118.28 120.02 119.15 1.74 1.46


2 117.94 119.82 118.88 1.88 1.58
3 117.25 119.55 118.40 2.30 1.94
4 117.63 119.59 118.61 1.96 1.65
5 117.29 119.15 118.22 1.86 1.57
6 116.35 118.51 117.43 2.16 1.84
7 116.41 118.31 117.36 1.90 1.62
8 116.15 118.16 117.16 2.01 1.72
9 116.23 118.24 117.24 2.01 1.71
10 116.35 117.99 117.17 1.64 1.40
11 117.38 117.91 117.65 0.53 0.45
12 117.35 118.23 117.79 0.88 0.75
13 117.48 118.60 118.04 1.12 0.95
14 117.17 118.34 117.76 1.17 0.99
15 117.50 118.62 118.06 1.12 0.95
16 117.43 118.93 118.18 1.50 1.27
17 117.73 119.00 118.37 1.27 1.07
18 117.67 119.04 118.36 1.37 1.16
19 117.88 119.04 118.46 1.16 0.98
20 116.98 118.44 117.71 1.46 1.24

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.

Analysis. performance may not have been significant enough to be detected


It is widely accepted that reuse of the same dialyzer could cause as a confounder. Nevertheless, it is our conviction that repetitive
alteration of membrane pore sizes and also lead to twist of hollow use of the same dialyzer for more than 20 times or the reuse until a
fibers, resulting in decline in membrane performance [23,24]. TCV value was less than 85%e90% could lead to error which may
Multiple use of the same dialyzer may have also interfered with the have affected the results of statistical analysis and agreement be-
results by increasing variation of the mean ± SD and acted as a tween the two methods. In addition, the limitation of the study is
confounder. We used mean ± SD in determination of the upper and the order effect, measuring the TCV by machine before by the
lower limits of agreement, so any error in mean ± SD could affect conventional method, might show the different results causing
the results of statistical analysis. The plots out of the limits of from more filling fluid volume of reprocessing methods by ma-
agreement could be an error resulting from the variation caused by chine. For this reason, there should be further studies on effects of
repetitive use of the same dialyzer. Subsequent analyses on each such repetitive use.
period of reuse aiming to reduce effects of such confounder showed Due to the lack of data on the reliability of performance when
the same results in both the conventional and automated machine the reuse times are more than 5 and 20 times in low-flux and high-
groups. The results of the subsequent analysis indicated that the flux dialyzers, it is necessary that TCV evaluation should be
decline in membrane performance did not affect agreement on TCV measured by the conventional method to figure out a performance
evaluation by machine when compared to the conventional index before reuse. In addition, if a TCV value is less than 85% when
method. However, for the last reuse time of high-flux, the average measured by machine, we strongly recommend TCV measurement
TCV value was approximately 94% when measured by the con- by the conventional approach. It is because when an actual TCV was
ventional method (data not shown). The decline in membrane less than 80%, the membrane performance may have not been able

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

Total (1e20 reuses)


1.67 0.66 1.41 ± 0.56 2.95 0.38
Reused 1e5
1.95 0.21 1.64 ± 0.18 2.36 1.53
Reused 6e10
0.96 1.01 0.82 ± 0.85 2.93 1.00
Reused 11e15
0.96 0.27 0.82 ± 0.23 1.49 0.44
Reused 16e20
1.41 0.16 1.20 ± 0.14 1.72 1.10

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

Human Research Ethics Board of Srinakharinwirot University (Issue References


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