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Annual Dialysis Data Report 2014, JSDT Renal Data Registry (JRDR)

Abstract

Background

The Japanese Society for Dialysis Therapy (JSDT) has performed a nationwide renal data registry since 1966. The data from the survey have been used for promoting dialysis facilities to improve dialysis quality and developing JSDT guidelines. Here, we summarized the current status of chronic dialysis in Japan as of 31 December 2014.

Methods

The annual survey was conducted targeting for 4367 dialysis facilities by electrically and partially paper-based; among which, 4330 (99.2%) responded. The results shown in this report are all descriptive, and no statistical analyses were conducted.

Results

The number of the incident dialysis patients was 38,327 and that of the prevalent dialysis patients was 320,448 in 2014. The count of prevalent dialysis patients per million population was 2517. The count of dialysis patients who died in 2014 was 30,707, and the crude mortality rate was 9.6%. The mean age of incident dialysis patients was 69.04 years, and the mean age of the prevalent dialysis patients was 67.54 years. The most common primary cause on the incident and prevalent dialysis patients was diabetic nephropathy. The patient count on hemodiafiltration (HDF) at the end of 2014 was 43,283; in particular, the number of online HDF patients increased more than 2.5 times over the last 3 years. The facility survey showed that 9255 patients were on peritoneal dialysis (PD) in 2014. Among them, 1913 patients were treated by the combination of PD and hemodialysis (HD) or HDF. The number of patients treated by home HD at the end of 2014 was 529, a continued increase from that at the end of 2013 as 461.

Conclusions

The chronic dialysis population in Japan has been still increasing and becoming older year by year. The rapidly increasing number of online hemodiafiltration is an emerging trend but the penetration rate of home therapies by peritoneal dialysis and home hemodialysis was still the lowest in the world.

Trial registration

UMIN000018641

Outline of JSDT Renal Data Registry

Introduction

The Japanese Society for Dialysis Therapy (JSDT) has been annually surveyed the status of chronic dialysis since 1968, and it was named the JSDT renal data registry (JRDR). In the early surveys, only the counts of patients and dialysis-beds in dialysis facilities were recorded annually. Since 1983, clinical data of all dialysis patients treated in the facilities that participated in the surveys have been collected. The results from these surveys were summarized as the annual renal data report and also used for making JSDT guidelines and standards. JRDR is respected worldwide as an unbiased complete patient census.

Before 2014, the results from JRDR had been reported in following three types of report. First, quick analyses of the data obtained by April in the following year were reported at the annual meeting of the JSDT held in June and compiled in “The Atlas, Overview of Regular Dialysis Treatment in Japan”. Second, the responses to the survey had been continuously collected until September, and the obtained data were screened to determine the definite survey results, which were published in the “An Overview of Regular Dialysis Treatment in Japan, the CD-ROM Report”. Third, the tabulated results based on the definite values in the CD-ROM report were published as an annual dialysis data report in the Journal of Japanese Society for Dialysis Therapy. Therefore, the values in the atlas were different from the definite values in the CD-ROM. The quick estimations were prepared only for the atlas in the annual meeting of JSDT. However, the values in the atlas had been occasionally cited as if they were officially approved values because they were expressed by attractive graphs. To avoid these mal-citations, we decided to publish all the official reports from the 2014 survey based on the definite database.

All the figures and tables included in the CD-ROM report have been made available on the members-only pages of the JSDT website since 2012 to widely provide the survey findings among JSDT members. These pages contain all the findings from the first survey conducted in 1968 to the latest survey. All figures and tables in the website in JRDR have been updating if any errors had been found so these updated data should be used for any academic and social analyses. On the other hand, the summaries of survey results in the illustrated report are available for the general public on the JSDT website (http://www.jsdt.or.jp/overview_confirm.html). A review report should be referred for the historical background of the annual survey and the survey items in the previous surveys [1].

The current manuscript is the second publication of An overview of regular dialysis treatment in Japan (as of December 31, 2014) J Jpn Soc Dial Ther 49(7):1–34, 2016, written in Japanese.

Subjects and methods

Survey method

The JSDT survey is conducted annually by sending questionnaires to all dialysis facilities in Japan at the end of each year. A total of 4367 facilities surveyed were either member facilities of JSDT, nonmember facilities offering regular maintenance hemodialysis (HD), or nonmember facilities offering peritoneal dialysis (PD) but not HD as of 31 December 2014. The number of facilities participating in this survey increased by 42 (1.0%) from 2013 as 4325 facilities [2].

The questionnaires were mainly sent and collected by postal mail; the rest of them were also faxed. Universal serial bus (USB) memory devices with stored electronic spreadsheets in Microsoft Excel format were also sent with the printed questionnaires to the facilities. The facilities were requested to use these devices for the completion of the questionnaires as much as possible.

In this survey, two sets of questionnaires were used. One was for the facility survey, which included questions about dialysis facilities, such as the number of patients and the number of staff members. The other was for the patient survey, which included items on the epidemiological background, treatment conditions, and the outcome of the treatment of individual dialysis patients.

The deadline for the acceptance of responses was the end of January in 2015. The acceptance of responses submitted after this deadline, including those of the additional surveys, ended on 7 August 2015.

As previously addressed, we decided to publish the annual report based on the definite database from 2014, so all values in this report are officially approved and the same as those in the CD-ROM. Based on the defined database, the count of facilities that responded to the facility survey was 4330 (99.2%), and the count of facilities that responded to both the facility and patient surveys was 4191 (96.0%). Moreover, the facilities that completed the questionnaires using the electronic medium (3764 facilities, 86.9%) further increased from the 2013 survey (3698 facilities, 86.6%). This increase contributed to the accurate and simplified analysis of survey data [3].

Survey items

The collected data in the 2014 survey were classified to the following two categories as facility data and patient data. The items in the previous surveys are found on the members-only pages of the JSDT website (http://www.jsdt.or.jp/).

Facility survey

The following are the items surveyed in the 2014 survey and are the same as those in the 2013 survey [2].

  • Name and contact numbers (TEL, FAX) of facility

  • Year and month when the facility started providing dialysis treatment

  • Capacity for simultaneous hemodialysis treatments

  • Maximum capacity for hemodialysis treatments

  • Number of bedside consoles

  • Number of workers involved in dialysis treatment (e.g., doctors, nurses, clinical engineers, nutritionists, case workers)

  • Number of dialysis specialists

  • Number of prevalent dialysis patients at the end of 2014 (daytime dialysis, nighttime dialysis, home HD, PD)

  • Number of HD/HDF patients with PD catheter (non-PD + catheter patients)

  • Number of patients treated by the combination of PD and HD/HDF (PD + HD patients)

  • Number of inpatients on dialysis at the end of 2014

  • Number of incident dialysis patients

  • Number of the incident PD patients who changed a dialysis modality during 2014 (PD dropout patients)

  • Number of deceased patients during 2014

  • Number of bedside consoles equipped with an endotoxin retentive filter (ETRF)

  • Use or nonuse of ETRFs for sampling dialysis fluid

  • Sampling site of dialysis fluid

  • Frequency for measuring endotoxin concentration in dialysis fluid

  • Endotoxin concentration in dialysis fluid

  • Frequency for measuring total viable microbial count (TVC) in dialysis fluid

  • Sampling volume for TVC

  • Cultivation medium for TVC

  • TVC in dialysis fluid

  • Patient survey

The following are the basic survey items that have been annually surveyed since 1983.

  • Anonymized name

  • Gender

  • Date of birth

  • Year and month of start of dialysis

  • Year and month of transfer from another hospital

  • Primary disease

  • Residence (prefecture)

  • Dialysis modality

  • Outcome (transfer, death, dropout, or transplantation)

  • Outcome date

  • (in case of facility transfer) Facility code

  • Cause of death

The following were added to the above basic survey items and were surveyed using both paper and electronic media.

  • Current status of the combination of PD + HD

  • Treatment history of PD

  • Number of past renal transplantations

  • Frequency of dialysis session per week

  • Dialysis time per session

  • Blood flow rate

  • Dilution mode in HDF

  • Substitution fluid volume per HDF session

  • Body height

  • Predialysis and postdialysis body weight

  • Predialysis and postdialysis blood urea nitrogen (BUN) concentration

  • Predialysis and postdialysis serum creatinine concentration

  • Predialysis serum albumin concentration

  • Predialysis serum C-reactive protein (CRP) concentration

  • Predialysis serum calcium concentration

  • Predialysis serum phosphorus concentration

  • Measurement method for serum parathyroid hormone (PTH) concentration

  • Intact and whole PTH concentration

  • Predialysis hemoglobin (Hb) concentration

  • Use or nonuse of antihypertensive agent

  • Smoking habit

  • History of diabetes

  • History of myocardial infarction

  • History of cerebral hemorrhage

  • History of cerebral infarction

  • History of major amputation

  • History of femoral neck fracture

  • History of encapsulating peritoneal sclerosis (EPS)

The following were added to the basic survey items and were collected only by the USB survey.

  • Serum total cholesterol concentration

  • Serum high-density lipoprotein cholesterol (HDL-C) concentration

  • Predialysis systolic blood pressure

  • Predialysis diastolic blood pressure

  • Predialysis pulse rate

The following were surveyed only for PD patients and were collected only by the USB survey.

  • PD vintage

  • Number of months in which PD was performed in 2014

  • History of peritoneal equilibrium test (PET)

  • Four-hour creatinine concentration dialysate/plasma ratio in PET (PET Cr D/P ratio)

  • Type of PD fluid (PD fluid type)

  • Volume of PD fluid per day (PD fluid volume)

  • PD treatment time per day

  • Daily urine volume (Urine volume)

  • Mean ultrafiltration (UF) volume per day (UF volume)

  • Kt/V by residual kidney (Residual kidney Kt/V)

  • Kt/V by PD (PD Kt/V)

  • Changing maneuver of PD fluids

  • Use or nonuse of automated peritoneal dialysis (APD) machine

  • Past histories of peritonitis during 2014

  • Past histories of exit-site infections during 2014

Calculation of survival rate

The cumulative survival rate after the start of dialysis was actuarially calculated [4].

Contents of the 2014 annual dialysis data report of JSDT

  1. I.

    Outline of JSDT Renal Data Registry (JRDR)

  2. II.

    Results and discussion from JRDR

  • Chapter l: Basic demographics

  • Chapter 2: Current status of microbiological quality of dialysis fluid and its control

  • Chapter 3: Current status of hemodiafiltration

  • Chapter 4: Current status of peritoneal dialysis

  • II. Results and discussion from JRDR

Chapter 1: Basic demographics

Number of dialysis patients

Table 1 shows a summary of the dynamics of dialysis patients in Japan at the end of 2014. The number of facilities that responded to the facility survey in 2014 was 4330, an increase of 62 (1.4%) from 4268 facilities in 2013. Dialysis facilities have been continuously increasing by 100 or less every year since 2000. In Table 1, data on dialysis vintage and the longest dialysis vintage were obtained from the patient survey. All the other results were obtained from the facility survey.

Table 1 Summary of chronic dialysis therapy in 2014

As determined from the facility survey, the prevalent dialysis patients in Japan at the end of 2014 were 320,448 (Table 1). Table 2 shows changes in number of prevalent, incident, and deceased dialysis patients over the last 20 years. The number of dialysis patients in 2014 increased by 6010, which was greater than 4431 in 2013. However, the increasing rate in prevalent dialysis patients has generally decreased since 2000. The annual increasing rate of the prevalent dialysis patients is defined as the ratio of the increase in dialysis patients each year to the dialysis patients at the end of the previous year. The future trend of dialysis patient population in Japan has been estimated by assuming that this trend of annual rate increase continues in the future. As reported previously, the dialysis patient population in Japan is expected to reach the maximum (approximately 348,000) around 2021 and then start decreasing [5].

Table 2 Prevalent, incident, and deceased dialysis patient counts and adjusted rate

The number of incident dialysis patients was 38,327 in 2014, as shown by the facility survey. The annual number of incident dialysis patients continued to increase from the start of the survey. Since 2008, incident dialysis patients remained around 38,000 (Table 2).

The annual increasing rates of incident dialysis patients from 2002 adjusted by the recovery rate for the facility survey are plotted in Fig. 1, similarly to the 2013 survey [2]. According to the regression line for the annual increasing rates of incident dialysis patients, the turning point when the incident dialysis patients stop increasing was expected to be in 2013, as shown in the 2013 survey report [2]. These lines of evidences suggested that incident dialysis patients will gradually decrease in the future.

Fig. 1
figure 1

Annual increasing rate of incident dialysis patients

The total count of deceased dialysis patients in 2014 was 30,707 (Table 1). The annual count of deaths continued to increase until 2011, but it has been around 30,000 since 2012 [2]. Similarly to the previous report, the trend of the annual increasing rates of deceased patients over the past 12 years from 2002 was examined (Fig. 2). The increasing rate of deaths remained around 4% until 2011 with slight yearly fluctuations. However, the increasing rates following 3 years (2012–2014) was almost 0%. The regression line for the increasing rates of the annual number of deaths between 2012 and 2014 is obviously decreasing. If this trend continues, the annual number of deaths stops increasing in 2017. However, it can also be interpreted that the rate of increase in the annual number of deaths has fluctuated since 2012, requiring careful attention to future trends.

Fig. 2
figure 2

Annual increasing rate of deceased dialysis patients

In the 4330 facilities that responded to the facility survey questionnaire, the total number of bedside consoles was 131,555, an increase of 3405 (2.7%) from the previous year. The capacity for simultaneous hemodialysis treatments in all facilities was 129,860, and the capacity for the maximum dialysis patients was 432,433, increases of 2.9 and 2.4% from the previous year, respectively. As mentioned above, the total number of patients on chronic dialysis in Japan is expected to reach a maximum of approximately 348,000 in 2021 and then gradually decrease; this is expected even when taking into consideration the number of patients treated in dialysis facilities that did not respond to this survey [5]. Therefore, the capacity for dialysis patients in 2014 had been already larger than the expected number of the maximum dialysis patients.

The percentage of patients on daytime dialysis was 84.1% of the dialysis patients in 2014, which was 0.4% higher than the previous year (Table 1). In contrast, the nighttime dialysis patient was 12.9%, which was 0.3% lower than 13.2% in the previous year. The absolute number of patients on nighttime dialysis remained in the range of 41,000–42,000 over the last 10 years (Table 3). The number of patients on home HD was 529, an increase of 68 (14.8%) from 461 in the previous year and which has been increasing rapidly since 2006 (Table 3).

Table 3 Modalities in prevalent dialysis patients

The prevalent patients on PD was 9255, which was 2.9% of all dialysis patients. Although the number of PD patients was maximum at 9858 in 2009, it had been gradually decreasing since then (Table 3). The count of PD + HD patients was 1913 in the 2014 survey, and it had remained around 1900 since 2009. The count of non-PD + catheter patients, it was probably for peritoneal lavage, was 278 and that of PD dropout patients during 2014 was 193.

As shown in Table 3, the number of hemodiafiltration (HDF) patients had been rapidly increasing since 2012 and reached 43,283 in 2014. The demographics of HDF patients are described in detail in Chapter 3: Current status of hemodiafiltration.

According to the patient survey, the longest dialysis vintage was 46 years and 6 months (Table 1). Table 4 shows the total number of dialysis patients in each prefecture of Japan determined from the facility survey.

Table 4 Prevalent dialysis patient counts by modality and prefecture

Mean age

The dialysis patient population in Japan is aging yearly. Table 5 shows the changes in the mean age of the prevalent and incident dialysis patients obtained from the patient survey. The mean age of the incident dialysis patients in 2014 was 69.0 ± 13.4 years [mean ± standard deviation (S.D.)] and that of the prevalent dialysis patients was 67.5 ± 12.5 years. In last two decades from 1994 to 2014, the mean age of dialysis patients had become 6.0 years older from 57.3 to 63.3 years in the first decade, and 4.2 years older from 63.3 to 67.5 years in the second decade. Similarly, the mean age of incident dialysis patients had become 5.3 years older from 60.4 to 65.8 years in the first decade and from 65.8 to 69.0 years in the second decade. These findings showed that the rate of aging of both prevalent and incident dialysis patients was also slowing down. The incident patient distribution by gender and age was summarized in Table 6, and the prevalent patient distribution by gender and age was summarized in Table 7.

Table 5 Mean age of prevalent and incident dialysis patients
Table 6 Incident dialysis patient distribution by gender and age
Table 7 Prevalent dialysis patient distribution by gender and age

Primary diseases

Three major primary diseases of end-stage kidney disease (ESKD) were diabetes, chronic glomerulonephritis, and nephrosclerosis. The three major and other primary diseases of ESKD were summarized by gender and age in the incident patients (Table 8) and in the prevalent patients (Table 9). Diabetes was the most frequent primary disease as 43.5%, followed by chronic glomerulonephritis as 17.8% (Table 10 upper panel). The number and percentage of diabetes of the cause of ESKD on the incident dialysis patients had been increased until the end of 2009 and reached 16,549 and 44.5%, respectively, in 2009 (Table 10 upper panel, Fig. 3 Left). However, they had stopped increasing and started decreasing since 2011. Annual increasing rates of chronic glomerulonephritis and diabetes after 2002 were plotted in Fig. 4. The increasing rates were collected by the responsive rate to the survey. The increasing rate of diabetes had been positive until 2009 but turned to be negative since 2012. It suggests that the number of the incident dialysis patients with diabetes is expected to gradually decrease continuously in the future. In contrast, the increasing rate of chronic glomerulonephritis had been negative for more than the recent 10 years, indicating that the number of the incident dialysis patients with chronic glomerulonephritis continued to decrease. Nephrosclerosis was the third most common primary disease (14.2%) after diabetes and chronic glomerulonephritis. In accordance with the aging of incident dialysis patients, the percentage of patients with nephrosclerosis continued to increase steadily. The percentage of patients with “unspecified” primary diseases was the fourth highest (11.3%). In addition, polycystic kidney disease (PKD), rapidly progressive glomerulonephritis (RPGN), lupus, and chronic pyelonephritis were also observed as primary diseases. However, the percentages of these primary diseases among the incident dialysis patients were 0.7–2.7%, which were much lower than the percentages of patients with the abovementioned top three primary diseases and unspecified diseases, and had shown no marked increase or decrease over the past 20 years.

Table 8 Incident dialysis patient distribution by age and primary disease
Table 9 Prevalent dialysis patient distribution by age and primary disease
Table 10 Annual changes of primary disease in the incident and prevalent dialysis patients
Fig. 3
figure 3

Annual changes in the distributions of three major primary diseases in the incident patients (left) and the prevalent patients (right)

Fig. 4
figure 4

Annual increasing rates of incident dialysis patients from diabetes and chronic glomerulonephritis

Chronic glomerulonephritis was the most common primary disease in the prevalent dialysis patients but the percentage of chronic glomerulonephritis has been decreasing. In contrast, the percentage of diabetes has been increasing and it has been the most common primary disease in the prevalent dialysis patients since 2011. (Table 10 lower panel, Fig. 3 Right) In 2014, the percentage of diabetes further increased (38.1%), whereas that of chronic glomerulonephritis further decreased (31.3%). Nephrosclerosis was the third highest percentage of primary disease in the prevalent dialysis patients in 2014 (9.1%). The percentage of nephrosclerosis has been increasing. The percentage of patients with “unspecified” primary diseases was the fourth highest (8.9%). In addition, polycystic kidney disease, chronic pyelonephritis, lupus, and RPGN were also observed as primary diseases. However, the percentages of these primary diseases were only 0.7–3.5% and had shown no marked increase or decrease over the past 20 years.

Causes of death

The causes of death in the incident dialysis patients in 2014 were summarized in Table 11. The leading cause of death of them was infectious diseases (25.8%), followed by cardiac failure (23.8%), malignant tumors (11.4%), other causes (11.2%), and unspecified causes (7.8%). The causes of death in the prevalent dialysis patients in 2014 were summarized in Table 12. Table 13 shows annual changes in the percentages of the leading causes of death in prevalent dialysis patients. Among the prevalent dialysis patients, the leading cause of death in 2014 was cardiac failure (26.3%). The percentage of cardiac failure in prevalent dialysis patients had markedly decreased by the early 1990s, and it has remained almost unchanged. The second leading cause of death was infectious diseases (20.9%); the percentage of it had been increasing by 2009, and it has remained almost unchanged. The percentage of malignant tumors was 9.0%. The percentage cerebrovascular disease had continued to decrease since 1995 and was 7.1% in 2014. The percentage of myocardial infarction was 4.3% in 2014.

Table 11 Causes of death in incident dialysis patients
Table 12 Causes of deaths in prevalent dialysis patients
Table 13 Annual changes in major causes of death

The classification codes for the causes of death were revised in the 2003 and 2010 surveys. We speculate that these revisions might have had some influence on the distributions of causes of death. These revisions were detailed in the annual data report 2010 [6].

Annual crude death rate

The annual crude death rate was calculated from the facility survey data as shown in Table 14. The annual crude death rate is defined as the percentage of patients who died each year with respect to the mean annual dialysis patient counts. Table 14 shows the annual crude death rates between 1993 and 2014. It had remained in the range of 9.0–9.9% until 2010 but was in the range of 10.0–10.9% in 2011 and 2012. However, it was again in the range of 9.0–9.9% (9.8% in 2013 and 9.7% in 2014).

Table 14 Annual crude death rate

Cumulative survival rate of incident dialysis patients since 1983

The cumulative survival rates of the incident dialysis patients by the year of starting dialysis since 1983 are summarized in Table 15. The 1- to 10-year survival rates were the lowest for patients who started dialysis in 1992 and were increasing in patients in 1993 or later. However, the 5-year survival rate for patients who started dialysis between 2003 and 2009 and the 10-year survival rate for between 1998 and 2004 remained almost unchanged. The 20- or more year survival rates tended to decrease.

Table 15 Cumulative survival rates by incident year since 1983

Chapter 2: Current status of microbiological quality of dialysis fluid and its control

Measurement of endotoxin concentration in dialysis fluid

Among 4304 facilities that had at least one bedside console, 4229 facilities (98.3%) responded to the question about the frequency for measuring endotoxin. The JSDT standard [7] for microbiological quality of dialysis fluid recommends that the endotoxin concentration in dialysis fluid should be measured at least once a month. The percentage of the facilities that satisfied this recommendation was 78.7%, a slight increase from the previous year as 77.7% (Table 16).

Table 16 Facility distribution on ET measurement by frequency and concentration

Four thousand seventy-nine facilities (94.8%) responded to the question about the endotoxin concentration. According to the standard, ultrapure dialysis fluid (UPD) defined as endotoxin <0.001 EU/mL and total viable microbial count (TVC) <0.1 cfu/mL is recommended for all dialysis modalities; and standard dialysis fluid defined as endotoxin <0.05 EU/mL and TVC <100 cfu/mL is the minimum desirable quality to ensure the safety of dialysis therapy [7]. Endotoxin concentration of <0.001 and <0.05 EU/mL were achieved in 77.6 and 96.2% of the 4079 facilities, respectively. These percentages were higher than those in the previous year as 73.9 and 95.1%, respectively (Table 16).

Measurement of TVC in dialysis fluid

Four thousand twenty-seven (97.7%) among all 4304 facilities responded to the question about the frequency of measurement of TVC. The JSDT standard [7] recommends that the TVC in dialysis fluid should be measured at least once a month. The percentage of the facilities that satisfied this recommendation was 74.8% as similar as 74.7% in 2013 (Table 17).

Table 17 Facility distribution on microbial measurement by frequency and TVC

Three thousand nine hundred thirty facilities (91.3%) responded to the question about the TVC in dialysis fluid. As previously addressed, JSDT guideline defined two qualities on TVC: UPD as <0.1 cfu/mL and the standard dialysis fluid as 100 cfu/mL. TVC of <0.1 and <100 cfu/mL were achieved in 71.5 and 99.0% of the facilities that responded, respectively (Table 17).

Three thousand eight hundred forty of the facilities (89.2%) responded to the question about the culturing media for TVC. In the JSDT standard, Reasoner’s No. 2 agar (R2A) and tryptone glucose extract agar (TGEA) are recommended for TVC in dialysis fluid. The survey results showed that either of these media was used by 86.2% of the facilities that responded.

Three thousand nine hundred fifty of the facilities (91.8%) responded to the question about the sampling volume for TVC. As previously addressed, the JSDT standard recommended that UPD should be indicated for all types of extracorporeal dialysis treatments [7]. The requirement of TVC for UPD is <0.1 cfu/mL so it needs equal or greater than 10 mL of sampling volume of dialysis fluid. At least 10 mL of sampling was performed in 77.1% of the facilities that responded (Table 18). As previously addressed, UPD should satisfy both an endotoxin <0.001 EU/mL and TVC of <0.1 cfu/mL. However, the percentage of the facilities that satisfied TVC of <0.1 cfu/mL (71.5%) was approximately 6% lower than that of the facilities that satisfied the endotoxin <0.001 EU/mL (77.6%), indicating the need for the improvement of dialysis fluid quality control.

Table 18 Facility distribution on microbial measurement by cultivating medium and sampling volume

Installation of endotoxin retentive filters

Four thousand two hundred ninety-five (99.8%) responded to questions regarding the installation of endotoxin retentive filters (ETRFs). Among these 4295 facilities, 96.3% had at least one bedside console equipped with an ETRF (Table 19). The 4304 facilities that responded to the questions about the installation of ETRFs had a total of 131,555 bedside consoles, 88.6% of which were equipped with an ETRF. The percentage of bedside consoles equipped with an ETRF increased by 2.6% from the previous year (86.0%) (Table 20) [2].

Table 19 Facility counts by ETRF installation
Table 20 Bedside console counts by ETRF installation

Theoretically, UPD can be achieved by using an ETRF based on its retentive performance. If facilities cannot achieve UPD even with ETRF, these facilities may have some problems in preventing the contaminations, such as a high contamination level of raw water, a high level of secondary contamination, contamination of ETRF itself, or contamination during sampling. These facilities need to optimize their maneuver of the disinfection of the entire system. The percentages of facilities that did not achieve the required endotoxin of <0.001 EU/mL and TVC of <0.1 cfu/mL with ETRFs were 20.1 and 25.9%, respectively (Tables 21 and 22). Standard dialysis fluid should have an endotoxin of <0.050 EU/mL and TVC of <100 cfu/mL. Among the facilities that had bedside consoles equipped with an ETRF, 3.3% did not achieve the required endotoxin and 0.8% did not achieve the required TVC. In contrast, 66.7 and 58.5% of the facilities without ETRFs satisfied the endotoxin and TVC of UPD, respectively. These results suggest that the technologies for purifying dialysis fluid have advanced to ensure the purification in the entire dialysate supply system. However, the data also suggested that dialysis fluid was contaminated by mal-handlings of an ETRF in some cases.

Table 21 Facility distribution on endotoxin measurement by endotoxin concentration and ETRF installation on sampling
Table 22 Facility distribution on microbial measurement by TVC and ETRF installation on sampling

Endotoxin concentration and TVC in dialysis fluid

According to the JSDT standard for on the microbiological quality of dialysis fluid, UPD is recommended for all dialysis methods [7]. UPD is defined as an endotoxin of <0.001 EU/mL (lower than the detection limit) and TVC of <0.1 cfu/mL [7]. Among the 4304 facilities that had at least one bedside console, 3919 (91.1%) responded to each question of endotoxin and TVC in dialysis fluid, among which, 2602 satisfied the above standards for UPD. They accounted for 66.4% of the facilities that responded to the questions and 60.5% of all the facilities, which were higher than those in the previous year, 60.8 and 54.9%, respectively (Table 23).

Table 23 Facility distribution by endotoxin concentration and TVC

Changes in status of quality control of dialysis fluid

In the early 2000s, microbial contamination of dialysis fluid was considered an important factor affecting the quality of dialysis treatment. Moreover, a concern on the high possibility of bacterial contaminations in centralized dialysis fluid delivery system (CDDS) widely used in Japan was raised by overseas researchers. In response to this, the survey of the endotoxin level and TVC in dialysis fluid was started in 2006. The results have been referenced in revising the JSDT standard and the targets of endotoxin and TVC were changed in 2008, 2010, and 2012 [7,8,9]. Such a large-scale survey on dialysis fluid quality has been carried out and used for the revision of the standard only in Japan. With the above historical background, how the status of bacteriological contamination of dialysis fluid changed between 2006 and 2014 is reviewed below [2,11,12,13,14,, 6, 1015].

The percentage of facilities that measured endotoxin in dialysis fluid at least once a month was 36.0% in 2009, increased to 70.6% in 2010 because of the revision of the medical reimbursement, and continued to gradually increase to 78.7% in 2014 (Table 24). The measured endotoxin in dialysis fluid decreased yearly; 77.6% of the facilities achieved the required endotoxin of UPD (<0.001 EU/mL), and 96.2% of the facilities achieved the required endotoxin concentration of standard dialysis fluid (<0.050 EU/mL) (Table 25). In the 2008 survey, the endotoxin unit was changed from EU/L to EU/mL in accordance with the international standards. Because many errors resulting from the misunderstanding of the unit were found in the responses, the endotoxin concentration in dialysis fluid in the 2008 was excluded.

Table 24 Annual changes in frequency of endotoxin measurement
Table 25 Annual change in endotoxin concentration in dialysis fluid

The target of TVC in dialysis fluid was not included in the JSDT guidelines on dialysate quality control standards in 2005 [16]. Owing to the revision of the standard in 2008, it was recommended to measure TVC at least once a month similarly as well as endotoxin level [7]. In 2007 or previously, only 10–19% of the facilities measured TVC at least once a month. In 2010, however, the percentage of such facilities rapidly increased to 67.8% because of the revision of the medical reimbursement in that year and it gradually increased to 74.8% in 2014 (Table 26). The percentage of facilities that satisfied TVC for UPD (<0.1 cfu/mL) gradually increased to 71.5% in 2014. The percentage of facilities that satisfied standard dialysis fluid (<100 cfu/mL) was 99.0% (Table 27).

Table 26 Annual changes in frequency of TVC measurement
Table 27 Annual changes in TVC in dialysis fluid

Chapter 3: Current status of hemodiafiltration

Basal characteristics of HDF patients

Since the revision of the medical reimbursement for HDF made in April 2012 [9], the number of patients treated by online HDF have been rapidly increasing. The HDF patient count was 14,069 in 2012 and increased by 2.5-fold up to 36,090 in 2014 (Table 28) [2,14,, 6, 1315] whereas, the count of the patients on offline HDF decreased from 7157 in 2012 to 6315 in 2014. The percentage of patients on HDF of all dialysis patients has increased from 7.5% in 2012 to 14.5% in 2014.

Table 28 Annual patient count by in-center extracorporeal dialysis modality

The HDF patients’ distributions by age and gender were summarized (Table 29). For both males and females, the number of patients on HDF in the age group of 65–70 years was the largest, showing no significant difference in the age distribution by gender.

Table 29 Patient distribution on all types of HDF by gender and age

The primary diseases of the HDF patients were compared with in-center HD patients (Table 30). The prevalence of diabetes was lower in HDF patients than in in-center HD patients. Chronic glomerulonephritis was the most common in the HDF patients (37.7%), followed by diabetes (33.0%). This finding may be attributable to the fact that many of the HDF patients have a longer dialysis vintage than the in-center HD patients.

Table 30 Patient distribution by in-center HD/HDF and primary disease

The dialysis vintages of HDF patients were evaluated by gender (Table 31) and were compared among various extracorporeal dialysis modalities (Table 32). For dialysis vintages of <20 years, the percentage of male patients was higher than that of female patients. For dialysis vintages of ≥20 years, the ratio of males to females was nearly 1:1. Even among the patients with dialysis vintages of <2 years, 7.5% underwent online HDF. The percentage of patients on online HDF increased with increasing dialysis vintage. This suggests that at the time immediately after the start of dialysis, online HDF might be selected for the prevention of dialysis-related complications in the future.

Table 31 Patient distribution on all types of HDF by gender and dialysis vintage
Table 32 Patient distribution on in-center extracorporal dialysis by modality and dialysis vintage

Dilution mode and substitution volume

The majority of the patients on online HDF (91.8%) was treated by predilution, whereas that of offline HDF (86.8%) was performed in postdilution (Table 33). The mean substitution volume was compared between the patients on online and offline HDF by dilution mode (Table 34). In online HDF, the mean volumes were 39.6 and 10.6 L for predilution and postdilution, respectively. In offline HDF, the mean volumes were 10.2 and 8.0 L for predilution and postdilution, respectively.

Table 33 Patient distribution by dilution mode and HDF modality
Table 34 Mean substitution volume by dilution mode and online/offline

Changes in the substitution volume per session of online HDF between 2012 and 2014 are shown for the predilution (Table 35) and postdilution (Table 36) [2, 15]. For the predilution, the numbers of patients in all groups stratified by the volume of substitution fluid increased. However, the mean substitution volume in the entire online HDF patients remained almost unchanged at approximately 40 L in 2012–2014. The group of patients with 40–50 L of substitution volume was the largest in each year, and the percentage of this group increased over time. For the postdilution, the numbers of patients in the stratified groups with ≥10 L of substitution fluid tended to increase. In particular, the number of patients in the group with ≥20 L of substitution greatly increased over time, although the absolute number was still small. This finding indicates that an increasing number of patients has undergone postdilution online HDF using a large volume of substitution fluid, which is mainly performed in Europe.

Table 35 Annual changes in substitution volume of predilution online HDF
Table 36 Annual changes in substitution volume of postdilution online HDF

The changes in the substitution volume per session of offline HDF between 2012 and 2014 are shown for the predilution (Table 37) and the postdilution (Table 38) [2, 15]. The number of patients on predilution offline HDF was small but slightly increased, and the substitution volume among them also tended to increase. In contrast, in 2014, the number of patients on postdilution offline HDF decreased by approximately 1000 from the previous year. However, the percentages of patients with different volumes of substitution fluid have hardly changed in the 3 years and the mean volume of substitution fluid remained at approximately 8 L.

Table 37 Annual changes in substitution volume of predilution offline HDF
Table 38 Annual changes in substitution volume of postdilution offline HDF

The dialysis prescription is usually affected by the patient’s body size. The substitution volumes for HDF therapy were evaluated by body weight according to the dilution mode and gender. In the male patients on predilution HDF with body weight <50 kg, the percentages of the substitution volume as 20–40 and 40–80 L were similar. In case of body weight ≥50 kg, the percentage of those using 40–80 L of substitution fluid increased and exceeded 60% in the group of male patients who weighed ≥60 kg (Table 39). In the female patients on predilution HDF with body weight <40 kg, the percentage of 20–40 L of substitution fluid was almost the same as that of patients using 40–80 L. In case of body weight ≥50 kg, the percentage of 20–40 L of substitution fluid was almost the same as 40–80 L. The titration of substitution volume according to body weight was observed only in males but not in females (Table 40). In the postdilution mode, the male patients with body weight <50 kg were mostly treated with 5–10 L of substitution volume. In the male patients with body weight 60–70 kg, the patients treated with 10–20 L of substitution fluid was similar to that of 5–10 L. In the patients with body weight ≥70 kg, the percentage of patients using 10–20 L of substitution fluid was the highest (Table 41). In the female patients, the percentage of patients using 5–10 L of substitution fluid was greater than 50% in all weight groups (Table 42).

Table 39 Male patient distribution on predilution HDF by postdialysis body weight and substitution volume
Table 40 Female patient distribution on predilution HDF by postdialysis body weight and substitution volume
Table 41 Male patient distribution on postdilution HDF by postdialysis body weight and substitution volume
Table 42 Female patient distribution on postdilution HDF by postdialysis body weight and substitution volume

Blood flow rate and dialysis time

The distributions of blood flow rate in each HDF modality were summarized in Table 43. At least half of the online HDF patients were treated at a blood flow rate of ≥220 mL/min, whereas at least half of the offline HDF patients were treated at a blood flow rate of <220 mL/min. The mean blood flow rate was a little higher in predilution in online HDF but it was higher in postdilution in offline HDF.

Table 43 Patient distribution on online/offline HDF by blood flow rate and dilution mode

Table 44 shows the distributions of dialysis session time in each HDF modality. The dialysis time per session was independent of the HDF method and dilution mode. Many HDF patients tended to undergo HDF for 4.0–4.5 h per session.

Table 44 Patient distribution on online/offline HDF, by dialysis time & dilution mode

Comparison between in-center HD and HDF patients

Characteristics of the patients treated by in-center HD and HDF were compared by dilution mode (Table 45). The patients with dialysis vintage of ≥2 years and treated on 3 times per week dialysis program were included to the comparison. The mean age of the in-center HD patients was the highest, whereas the online HDF patients were younger than the patients who underwent other types of dialysis. The dialysis vintage was the shortest in the in-center HD patients and the longest in the offline HDF patients. The postdialysis body weight and percentile creatinine generation rate (%CGR), which is an index of muscle mass, were high in the online HDF patients. CRP was low in the online HDF patients. The indices related to mineral and bone disorder on chronic kidney disease (CKD-MBD) and Hb showed no remarkable differences between the modalities.

Table 45 Comparison of characteristics between in-center HD and HDF patients by dilution mode

Chapter 4: Current status of peritoneal dialysis

The results of the facility survey shown in Table 1 revealed that the prevalent PD patient count was 9255 at the end of 2014. Moreover, the number of patients who had a PD catheter but were supposed to use it only for peritoneal lavage was 278. The number of patients who started PD in 2014 but stopped PD and introduced to another method during 2014 was 193. The detailed results of the PD survey are reported separately. Therefore, only a basic summary of the results is included in this report.

Combination therapy of PD and other dialysis modalities

Prevalent patient distributions on the combination of PD and other dialysis modalities (PD + HD) were summarized in Table 46. The main dialysis methods are categorized on the basis of the classification codes for dialysis methods that have been conventionally used in the patient survey. Among the 310,086 patients who responded to questions regarding the status of PD + HD in the patient survey, 301,063 (97.1%) underwent a non-PD dialysis modalities such as HD (non-PD patients) and 9023 (2.9%) underwent PD alone or PD + HD. The count of non-PD patients increased from 2013 as 297,773, whereas that of PD patients decreased by 98 from 2013 as 9121.

Table 46 Patient distribution by modality and combination of PD

Among the 301,063 of non-PD patients, 269 patients had a PD catheter (i.e., non-PD + catheter patients). Most of these patients were switched to HD from PD but did not have their PD catheter removed. There was also one non-PD + catheter patient among the 519 patients who underwent home HD. In this survey report, non-PD + catheter patients were tentatively classified and counted as patients who did not undergo PD in the analysis of the survey data. Note that this is only a tentative classification and that the Committee of Renal Data Registry (CRDR) of JSDT does not intend to standardize the above definition.

The count of PD-only patients was 7188, which was smaller than that in 2013 as 7324. The percentage of PD-only patients in all 9023 PD patients was 79.7%, which was smaller than that in 2013 as 80.3%. Moreover, the number of patients of PD + HD was 1835, which was larger than that in 2013 as 1797. The percentage of PD + HD patients in the entire PD patient population was 20.3%, which was larger than that in 2013 as 19.7%.

Among 1835 PD + HD patients, 1544 (84.1%) underwent a non-PD dialysis modality once a week, 177 (9.6%) in twice a week, 40 (2.2%) in three times a week, and one patient in four times a week. There were also 73 patients (4.0%) of PD + HD at frequencies other than those mentioned above.

There were various main dialysis method codes in 1835 PD + HD patients (shaded area in Table 46) because the choice of a code for the main dialysis method was just dependent on the responder’s decision.

This classification of the main dialysis modality for the PD + HD patients have been a tentative one by CRDR, a standardized classification for the PD + HD patients had not been established.

PD + HD and PD vintage

Table 47 shows the prevalent patient distribution by PD + HD and PD vintage. The responses for both the PD vintage and the status of PD + HD were recovered in 5678 PD + HD patients. The percentage of PD + HD patients even with a PD vintage of <1 year was 3.3% and increased with PD vintage: ≥1–<2 years, 10.1%; ≥2–<4 years, 16.3%; ≥4–<6 years, 26.9%; ≥6–<8 years, 40.9%; ≥8–<10 years, 53.5%; and ≥10 years, 58.7%. The majority (82.8%) of the PD + HD patients underwent HD or HDF once a week.

Table 47 PD patient distribution by PD vintage and PD combination

Abbreviations

AFBF:

Acetate free biofiltration

APD:

Automated peritoneal dialysis

BUN:

Blood urea nitrogen

CRDR:

The Committee of Renal Data Registry of the Japanese Society for Dialysis Therapy

ESKD:

End-stage kidney disease

ETRF:

Endotoxin retentive filter

HD:

Hemodialysis

HDF:

Hemodiafiltration

JRDR:

JSDT renal data registry

JSDT:

The Japanese Society for Dialysis Therapy

Kt/V:

Index for standardized dialysis dose defined as

PD:

Peritoneal dialysis

PIH:

Pregnancy-induced hypertension

PKD:

Polycystic kidney disease

Pmp:

Per million population

RPGN:

Rapidly progressive glomerulonephritis

TVC:

Total viable microbial count

UF:

Ultrafiltration

USB:

Universal serial bus

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Acknowledgements

We owe the completion of this survey to the efforts of the members of the subcommittee of the local cooperation mentioned as follows and the staff members of dialysis facilities who participated in the survey and responded to the questionnaires. We would like to express our deepest gratitude to all these people.

District Cooperative Committee: Noritomo Itami, Tetsuya Kawata, Chikara Oyama, Koji Seino, Toshinobu Sato, Shigeru Sato, Minoru Ito, Masaaki Nakayama, Atsushi Ueda, Takashi Yagisawa, Tetsuo Ando, Tomonari Ogawa, Hiroo Kumagai, Makoto Ogura, Takahiro Mochizuki, Ryoichi Ando, Kazuyoshi Okada, Tetsuya Kashiwagi, Chieko Hamada, Yugo Shibagaki, Nobuhito Hirawa, Junichiro Kazama, Yoichi Ishida, Hitoshi Yokoyama, Ryoichi Miyazaki, Mizuya Fukasawa, Masaki Nagasawa, Teppei Matsuoka, Akihiko Kato, Noriko Mori, Yasuhiko Ito, Hirotake Kasuga, Sukenari Koyabu, Takashi Udu, Tetsuya Hashimoto, Masaaki Inaba, Terumasa Hayashi, Tomoyuki Yamakawa, Shinichi Nishi, Akira Fujimori, Tatsuo Yoneda, Shigeo Negi, Akihisa Nakaoka, Takafumi Ito, Hitoshi Sugiyama, Takao Masaki, Yutaka Nitta, Hirofumi Hashimoto, Masato Yamanaka, Masaharu Kan, Kazumichi Ota, Masahito Tamura, Koji Mitsuiki, Yuji Ikeda, Masaharu Nishikido, Akira Miyata, Tadashi Tomo, Shoichi Fujimoto, Tsuyoshi Nosaki, Yoshinori Oshiro.

Funding

There are no funding for the current study.

All efforts and costs for the 2014 JRDR survey and making the report were totally given by JSDT.

Availability of data and materials

When anyone want to use the data and materials from the current manuscript without modifications, all data and materials are freely available with stating “data from JSDT”.

When anyone want to use the data and materials from the current manuscript with modifications, any re-calculations or something, they have to state the following sentence in their publication. “The data reported here have been provided by the Japanese Society for Dialysis Therapy (JSDT). The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official policy or interpretation of the JSDT.”

Authors’ contributions

IM was the director of CRDR in 2014 and directed all of the 2014 JRDR survey. IM and SN finalized the results of the survey and made this manuscript. SO and AW designed the survey sheets and made a special program mounted in MS Excel worksheet for the convenience of self-assessment for the dialysis quality of each dialysis facility. SN, NK, and TH had the responsibilities on the data analysis. KW had the responsibility on the ethical aspect of the JRDR survey. KN was the president of JSDT in 2014, and checked all the results from the 2014 JRDR survey, and approved them to be published. All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Not applicable.

Ethics approval and consent to participate

The JSDT registry was approved by the ethical committee of JSDT, the approval no. is 1.

The aims of JSDT Renal Data Registry (JRDR) were well explained for the participated dialysis patients through the dialysis facilities.

It does not always need to get the documented approval form from the patients because all the collected data were the existing ones and there were no new interventions.

The original data had been totally anonymized so there are no risks for deteriorating the privacy of the dialysis facilities and the patients.

The data presented in the current manuscript does not contain any images, videos, or voice recording which might have a risk for identifying an individual.

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Masakane, I., Nakai, S., Ogata, S. et al. Annual Dialysis Data Report 2014, JSDT Renal Data Registry (JRDR). Ren Replace Ther 3, 18 (2017). https://doi.org/10.1186/s41100-017-0097-8

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