Employment rates for working-age patients receiving hemodialysis increasing: Changing economic environment.

INTRODUCTION: This study explored employment trends among working-age patients undergoing hemodialysis using 5-year surveys from 1996 to 2021. Policy changes affecting individuals with disabilities, the economic environment, and employment status among the general population in Japan were considered. Differences in trends by gender and health status were examined. METHODS: Employment status was categorized into employment and nonemployment; and regular, nonregular, and self. Analytical data with similar characteristics were generated over the six surveys using the propensity score method. RESULTS: The employment rate, especially among women, increased from 1996 to 2021. However, the employment rate ratio to the general population was approximately 80% for men and 50% for women, even in 2021. The employment rate increased with an expansion in nonregular employment. Women's employment trends could be explained by changes in real gross domestic product and employment quotas for individuals with disabilities. CONCLUSION: Employment trends differ by gender and by regular versus nonregular employment.

A survey of environmental sustainability in Japanese dialysis facilities.

BACKGROUND: Dialysis practice has a particularly high environmental impact, including responsible for carbon emissions and climate change. Insufficient research has been conducted on environmental sustainability activities in dialysis therapy in Japan. METHODS: We conducted an online Green Survey comprising 30 question items based on a previously conducted survey in Australia. Between August and September 2023, this was sent to members of the Japanese Association of Dialysis Physicians, including hospital and clinic physicians, working across 885 dialysis facilities in Japan. RESULTS: In total, 255 (29%) facilities responded to the survey. More than half of the facilities (n = 157; 61.6%) responded that they did not have a strategy, policy, or action plan for environmental sustainability. In four-fifths of the facilities (n = 208; 81.6%), no "green team" or committee had been formed to promote environmental protection. By contrast, most of the surveyed facilities had emergency strategies for natural disasters, such as covering for patient visits and staff commuting during extreme weather conditions (n = 169; 66.3%), water shortages (n = 159; 62.4%), and power outages (n = 188; 73.7%). CONCLUSIONS: Following the UK, Australia and New Zealand, and Portugal, this is the fourth Green Survey to be conducted, and the first on environmental sustainability among kidney health-care providers in Japan. The results indicated that daily activities for environmental protection are still lacking at many facilities, even though the management of dialysis treatment during a natural disaster is well conducted.

Influence of dialysis-related stigma on health-related indicators in Japanese patients undergoing hemodialysis.

INTRODUCTION: Focusing on impacts to health-related indicators in older Japanese patients, this study analyzed both the direct influence of dialysis-related stigma and influences of its intersectionality with other stigmatized characteristics. METHODS: Data were collected through a cross-sectional survey of 7461 outpatients in dialysis facilities. Other stigmatized characteristics include lower income, lower education, disabled activities of daily living, and diabetic end-stage renal disease (ESRD) as a cause for starting dialysis treatment. RESULTS: The average rate of an "agree" response on dialysis-related stigma items was 18.2%. Dialysis-related stigma significantly influenced all three health-related indicators, including suspected depression, informal networks, and compliance with dietary therapy. In addition, each interaction between dialysis-related stigma and educational attainment, gender, and diabetic ESRD significantly influence one health-related indicator. CONCLUSION: These results suggest that dialysis-related stigma has both a significant direct and synergic influence with other stigmatized characteristics on health-related indicators.

Discordance between hemodialysis patients' reports and their physicians' estimates of adherence to dietary restrictions in Japan.

INTRODUCTION: This study examined the discordance between hemodialysis patients' reports and their physicians' estimates of dietary restriction adherence and related factors in Japan. METHODS: In a cross-sectional survey of 6644 outpatients, physicians who estimated higher and lower adherence than their patients' self-reported were categorized as overestimation and underestimation in terms of discordance, respectively. Possible factors included clinical indicators, patient characteristics related to negative stereotypes, and health beliefs related to statistical discrimination. RESULTS: The concordance rate was 0.069 based on the weighted kappa coefficient. The coefficients of acceptable serum potassium, prevalence of diabetes, and self-efficacy on overestimates were 0.663, -0.126, and -0.132, respectively. The coefficients of these factors on underestimates were -0.589, 0.338, and 0.145, respectively. All these coefficients were significant. CONCLUSIONS: The discordance may be high and is related to physicians' clinical data reliance, negative stereotypes about patient characteristics, and a lack of understanding of patients' health beliefs.

Effects of the Once-Weekly DPP4 Inhibitor Omarigliptin on Glycemic Control in Patients with Type 2 Diabetes Mellitus on Maintenance Hemodialysis: A 24-Week Open-Label, Multicenter Randomized Controlled Study.

INTRODUCTION: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in patients with type 2 diabetes mellitus (T2DM) on maintenance hemodialysis (HD), but the efficacy of the once-weekly DPP4 inhibitor omarigliptin is not known. METHODS: This prospective, randomized, open-label, parallel-group, non-inferiority/superiority, once-daily DPP4 inhibitor linagliptin-controlled, multicenter study examined glycemic control and safety of omarigliptin (UMIN000024284). Sample size was calculated to confirm non-inferiority in terms of changes in glycated hemoglobin (HbA1c). We enrolled 33 patients with T2DM on maintenance HD who had been treated with linagliptin for at least 3 months. The patients were randomized to receive omarigliptin (12.5 mg/week; n = 16) or linagliptin (5 mg/day; n = 17). Primary endpoints were changes in HbA1c and glycoalbumin (GA) over 24 weeks. RESULTS: Differences in the mean change in primary endpoint values between the omarigliptin and linagliptin groups were - 0.61% [- 1.14, - 0.09] for HbA1c, with a two-tailed upper 95% limit (i.e., one-tailed 97.5% upper limit) of 0.25%, below the non-inferiority limit, and - 1.67% [- 4.23, + 0.88] for GA, with a two-tailed upper 95% limit of 0.75%, above the non-inferiority limit. At 24 weeks, the omarigliptin group showed significantly greater reduction in HbA1c than the linagliptin group (- 0.2% ± 0.6% vs. 0.4% ± 0.8%, two-tailed p = 0.024) and significantly greater reduction in blood glucose after a single HD session (- 18.4 ± 31.4 mg/dL vs. 25.2 ± 59.5 mg/dL, respectively, two-tailed p = 0.019). No subjects in the omarigliptin group developed hypoglycemia. CONCLUSIONS: Our data showed that omarigliptin was non-inferior to linagliptin in glycemic control. Omarigliptin is feasible for glycemic control in patients with T2DM on maintenance HD. CLINICAL TRIALS REGISTRATION: UMIN000024284.

Prevention of Intradialytic Hypotension with Intermittent Back-Filtrate Infusion Haemodiafiltration: Insights into the Underlying Mechanism.

BACKGROUND: Intradialytic hypotension (IDH) is a major challenge to safely performing haemodialysis. Blood volume depletion due to fluid removal is a major cause of hypotension, so more emphasis should be placed on finding alternative modalities to traditional constant rate ultrafiltration. SUMMARY: Intermittent back-filtrate infusion haemodiafiltration (I-HDF) utilises purified online quality dialysate with an automated dialysis machine. A bolus of 200 mL of dialysate is repetitively infused at 30-min intervals. A pilot study with 68 hypotension-prone patients revealed that I-HDF can reduce the frequency of IDH interventions, particularly in elderly patients and patients with large interdialytic weight gain (IDWG). This was typically accompanied by an increase in intradialytic blood pressure and decreased tachycardia in the latter half of the session, suggesting reduced sympathetic stimulation during I-HDF. Protective mechanisms involved in the pathophysiology of IDH could be explained in part by the findings obtained in this pilot study. Intermittent increases in blood pressure during I-HDF may prevent venous pooling (i.e., the DeJager-Krogh phenomenon), and reduced sympathetic stimulation may maintain a physiological state less likely to induce the cardio-vagal reflex (i.e., the Bezold-Jarisch reflex). The plasma refilling rate (PRR), evaluated as the refilling fraction (RF), is unexpectedly smaller in I-HDF. However, in patients who respond, the RF is well achieved, which suggests that adequate PRR is the central physiology for preventing IDH. Patients for whom I-HDF is effective are characteristically relatively elderly and show increased IDWG. Blood pressure increment and reduced sympathetic activation in I-HDF may be a mechanism for prevention of IDH. Key Messages: Evaluating relative changes in blood volume during I-HDF will provide a new perspective for exploring appropriate ultrafiltration modification that circumvents IDH.

Feasibility of intermittent back-filtrate infusion hemodiafiltration to reduce intradialytic hypotension in patients with cardiovascular instability: a pilot study.

BACKGROUND: Intradialytic hypotension (IDH) is one of the major problems in performing safe hemodialysis (HD). As blood volume depletion by fluid removal is a major cause of hypotension, careful regulation of blood volume change is fundamental. This study examined the effect of intermittent back-filtrate infusion hemodiafiltration (I-HDF), which modifies infusion and ultrafiltration pattern. METHODS: Purified on-line quality dialysate was intermittently infused by back filtration through the dialysis membrane with a programmed dialysis machine. A bolus of 200 ml of dialysate was infused at 30 min intervals. The volume infused was offset by increasing the fluid removal over the next 30 min by an equivalent amount. Seventy-seven hypotension-prone patients with over 20-mmHg reduction of systolic blood pressure during dialysis or intervention-requirement of more than once a week were included in the crossover study of 4 weeks duration for each modality. In a total of 1632 sessions, the frequency of interventions, the blood pressure, and the pulse rate were documented. RESULTS: During I-HDF, interventions for symptomatic hypotension were reduced significantly from 4.5 to 3.0 (per person-month, median) and intradialytic systolic blood pressure was 4 mmHg higher on average. The heart rate was lower during I-HDF than HD in the later session. Older patients and those with greater interdialytic weight gain responded to I-HDF. CONCLUSIONS: I-HDF could reduce interventions for IDH. It is accompanied with the increased intradialytic blood pressure and the less tachycardia, suggesting less sympathetic stimulation occurs. Thus, I-HDF could be beneficial for some hypotension-prone patients. UMIN REGISTRATION NUMBER: 000013816.

Clinical outcomes of the high-performance membrane dialyzer.

HPM (high-performance membrane or high-flux membrane) has better biocompatibility and higher capacity to remove retention solutes of large molecular weight, which has been proven to be toxic especially to cardiovascular and skeletal organs. To date, several non-randomized observational studies have shown a reduction in morbidity and mortality in HPM-treated patients compared with low-flux conventional membrane. Meanwhile, two randomized controlled trials were unable to reveal the superiority of high-flux membrane in survival of all-cause mortality, but suggested a significant benefit by subgroup analyses or post-hoc analyses in patients with diabetes, hypoalbuminemia and long duration of prior dialysis. Thus, the results of the published studies are conflicting and it still cannot be explained whether the effect is based on the biocompatibility of the membrane or on the differences in the clearance of middle molecules, or on the microbiological purity of dialysate which improved simultaneously with the flux increment. As survival outcome might be determined by additional multiple confounding factors, dialysis-related or non-dialysis-related, investigations to control them are difficult to perform. Although the clinical results are non-conclusive and it is still unanswered how much large molecule removal is required to improve outcomes in routine clinical practice, there is a considerable amount of biological plausibility for high-flux dialysis or middle molecule removal. Further trials will be required to confirm what patient group benefits the most, the magnitude of advantages and how large the molecules are and how much molecule removal is acceptable using advanced high-performance dialyzers. Dispersing hazardous effects by a low-quality therapy should be taken more seriously than practicing a high-quality therapy of uncertain superiority.

Clinical evaluation indices for hemodialysis/hemodiafiltration in Japan.

Japanese hemodialysis (HD) patients have two remarkable characteristics, that is they have a longer period of chronic HD and better clinical outcome than American and European HD patients. This might be partly explained by the very low prevalence of renal transplantation in Japan. As a result, younger HD patients without serious comorbid conditions, whose prognosis should be good, have not been transplanted but have been treated by chronic HD therapy for a long period. Other potential explanations might be higher prevalence of biocompatible high-flux membrane dialyzers and lower prevalence of arteriovenous graft in Japan than Western countries. Although online hemodiafiltration has potential advantage over high-flux HD, the impact of this therapy has not been evident because of its low prevalence in chronic dialysis therapy in Japan.

Advances and advantages in recent central dialysis fluid delivery system.

The central dialysis fluid delivery system (CDDS) has been working exclusively in Japan since 1970, a fact which proves that CDDS is useful in the multi-patient treatment with in-center regular hemodialysis. It is a cost-effective, labor-saving and time-tested system with 40 years of experience. Microbial safety is improved by a refined system design, multiple endotoxin retentive filters (ETRF) and daily overnight disinfection of the entire system. Consequently, the usage of backfiltered dialysate is now accepted by regulatory authorities in some bedside consoles and even more the creation of dialysate is possible for infusion to meet its requirements. In many countries, especially in Asia, the number of end-stage renal disease patients is rapidly increasing. CDDS will contribute to such emerging situations with its easy handling and economical advantages.

Arresting dialysis-related amyloidosis: a prospective multicenter controlled trial of direct hemoperfusion with a beta2-microglobulin adsorption column.

We investigated the clinical efficacy of direct hemoperfusion with a beta2-microglobulin (beta2-m) adsorption column for the treatment of patients with dialysis-related amyloidosis. A 2-year prospective controlled study was performed to compare the effects of passaging blood through a (beta2-m) adsorption column (Lixelle) before it is passaged through the dialysis polysulfone membrane on the severity of amyloidosis in these individuals. Patients (n = 22) whose blood went through the Lixelle column prior to dialysis had a higher beta2-m removal rate compared to an equal number of controls, and they showed earlier improvement in their symptoms which included impaired daily activities, joint stiffness, and pain. The appearance of additional bone cysts was prevented in pre-adsorbed patients but not in the controls. Thus, the Lixelle column is useful in preventing the progression of dialysis-related amyloidosis and in ameliorating or arresting the progression of the symptoms of this disorder.

Internal filtration-enhanced hemodialysis is a cost-effective treatment in view of solute removal.

By modifying dialyzer module design, internal filtration (IF) within a dialyzer is enhanced to increase convective solute transport. Thus, it can be an alternative to hemodiafiltration with no requirement of substitution fluid or additional complex machines. Cost-effective analysis was conducted in three modes of therapy: high-flux hemodialysis, on-line hemodiafiltration and IF-enhanced hemodialysis. In IF-enhanced hemodialysis, cost-effectiveness of small solute removal is comparable with high-flux hemodialysis and that of beta(2)-microglobulin removal is the best. It is concluded that IF-enhanced hemodialysis is the most cost-effective therapy mode in comprehensive overall solute removal.