Effect of Remote and Virtual Technology on Home Dialysis.

In the United States, regulatory changes dictate telehealth activities. Telehealth was available to patients on home dialysis as early as 2019, allowing patients to opt for telehealth with home as the originating site and without geographic restriction. In 2020, coronavirus disease 2019 was an unexpected accelerant for telehealth use in the United States. Within nephrology, remote patient monitoring has most often been applied to the care of patients on home dialysis modalities. The effect that remote and virtual technologies have on home dialysis patients, telehealth and health care disparities, and health care providers' workflow changes are discussed here. Moreover, the future use of remote and virtual technologies to include artificial intelligence and artificial neural network model to optimize and personalize treatments will be highlighted. Despite these advances in technology challenges continue to exist, leaving room for future innovation to improve patient health outcome and equity. Prospective studies are needed to further understand the effect of using virtual technologies and remote monitoring on home dialysis outcomes, cost, and patient engagement.

Variation in Peritoneal Dialysis Time on Therapy by Country: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study.

BACKGROUND AND OBJECTIVES: Quantifying contemporary peritoneal dialysis time on therapy is important for patients and providers. We describe time on peritoneal dialysis in the context of outcomes of hemodialysis transfer, death, and kidney transplantation on the basis of the multinational, observational Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014 to 2017. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Among 218 randomly selected peritoneal dialysis facilities (7121 patients) in the PDOPPS from Australia/New Zealand, Canada, Japan, Thailand, the United Kingdom, and the United States, we calculated the cumulative incidence from peritoneal dialysis start to hemodialysis transfer, death, or kidney transplantation over 5 years and adjusted hazard ratios for patient and facility factors associated with death and hemodialysis transfer. RESULTS: Median time on peritoneal dialysis ranged from 1.7 (interquartile range, 0.8-2.9; the United Kingdom) to 3.2 (interquartile range, 1.5-6.0; Japan) years and was longer with lower kidney transplantation rates (range: 32% [the United Kingdom] to 2% [Japan and Thailand] over 3 years). Adjusted hemodialysis transfer risk was lowest in Thailand, but death risk was higher in Thailand and the United States compared with most countries. Infection was the leading cause of hemodialysis transfer, with higher hemodialysis transfer risks seen in patients having psychiatric disorder history or elevated body mass index. The proportion of patients with total weekly Kt/V ≥1.7 at a facility was not associated with death or hemodialysis transfer. CONCLUSIONS: Countries in the PDOPPS with higher rates of kidney transplantation tended to have shorter median times on peritoneal dialysis. Identification of infection as a leading cause of hemodialysis transfer and patient and facility factors associated with the risk of hemodialysis transfer can facilitate interventions to reduce these events. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_05_31_CJN16341221.mp3.

Epidemiology and outcomes in patients with anemia of CKD not on dialysis from a large US healthcare system database: a retrospective observational study.

BACKGROUND: Optimal management of anemia of chronic kidney disease (CKD) remains controversial. This retrospective study aimed to describe the epidemiology and selected clinical outcomes of anemia in patients with CKD in the US. METHODS: Data were extracted from Henry Ford Health System databases. Adults with stages 3a-5 CKD not on dialysis (estimated glomerular filtration rate < 60 mL/min/1.73m2) between January 1, 2013 and December 31, 2017 were identified. Patients on renal replacement therapy or with active cancer or bleeding were excluded. Patients were followed for ≥12 months until December 31, 2018. Outcomes included incidence rates per 100 person-years (PY) of anemia (hemoglobin < 10 g/dL), renal and major adverse cardiovascular events, and of bleeding and hospitalization outcomes. Adjusted Cox proportional hazards models identified factors associated with outcomes after 1 and 5 years. RESULTS: Among the study cohort (N = 50,701), prevalence of anemia at baseline was 23.0%. Treatments used by these patients included erythropoiesis-stimulating agents (4.1%), iron replacement (24.2%), and red blood cell transfusions (11.0%). Anemia incidence rates per 100 PY in patients without baseline anemia were 7.4 and 9.7 after 1 and 5 years, respectively. Baseline anemia was associated with increased risk of renal and major cardiovascular events, hospitalizations (all-cause and for bleeding), and transfusion requirements. Increasing CKD stage was associated with increased risk of incident anemia, renal and major adverse cardiovascular events, and hospitalizations. CONCLUSIONS: Anemia was a prevalent condition associated with adverse renal, cardiovascular, and bleeding/hospitalization outcomes in US patients with CKD. Anemia treatment was infrequent.

Contemporary outcomes of anemia in US patients with chronic kidney disease.

BACKGROUND: Long-term clinical outcome data from patients with non-dialysis-dependent (NDD) chronic kidney disease (CKD) are lacking. We characterized patients with NDD-CKD and anemia using real-world data from the USA. METHODS: This retrospective longitudinal observational study evaluated integrated Limited Claims and Electronic Health Record Data (IBM Health, Armonk, NY), including patients ≥18 years with two or more estimated glomerular filtration rate (eGFR) measures <60 mL/min/1.73 m2 ≥90 days apart. Anemia was defined as the first observed hemoglobin <10 g/dL within 6-month pre- and post-CKD index date. Data were analyzed from January 2012 to June 2018. Patients with documented iron-deficiency anemia at baseline were excluded. RESULTS: Comprising 22 720 patients (57.4% female, 63.9% CKD stage 3, median hemoglobin 12.5 g/dL), median (interquartile range) follow-up for patients with and without anemia were 2.9 (1.5-4.4) and 3.8 (2.2-4.8) years, respectively. The most prevalent comorbidities were dyslipidemia (57.6%), type 2 diabetes mellitus (38.8%) and uncontrolled hypertension (20.0%). Overall, 23.3% of patients had anemia, of whom 1.9% and <0.1% received erythropoiesis-stimulating agents (ESAs) or intravenous iron, respectively. Anemia prevalence increased with CKD stage from 18.2% (stage 3a) to 72.8% (stage 5). Patients with anemia had a higher incidence rate of hospitalizations for heart failure (1.6 versus 0.8 per 100 patient-years), CKD stage advancement (43.5 versus 27.5 per 100 patient-years), and a 40% eGFR decrease (18.1 versus 7.3 per 100 patient-years) versus those without anemia. CONCLUSIONS: Anemia, frequently observed in NDD-CKD and associated with adverse clinical outcomes, is rarely treated with ESAs and intravenous iron. These data suggest that opportunities exist for improved anemia management in patients with NDD-CKD.

Methods and rationale of the DISCOVER CKD global observational study.

BACKGROUND: Real-world data for patients with chronic kidney disease (CKD), specifically pertaining to clinical management, metabolic control, treatment patterns, quality of life (QoL) and dietary patterns, are limited. Understanding these gaps using real-world, routine care data will improve our understanding of the challenges and consequences faced by patients with CKD, and will facilitate the long-term goal of improving their management and prognosis. METHODS: DISCOVER CKD follows an enriched hybrid study design, with both retrospective and prospective patient cohorts, integrating primary and secondary data from patients with CKD from China, Italy, Japan, Sweden, the UK and the USA. Data will be prospectively captured over a 3-year period from >1000 patients with CKD who will be followed up for at least 1 year via electronic case report form entry during routine clinical visits and also via a mobile/tablet-based application, enabling the capture of patient-reported outcomes (PROs). In-depth interviews will be conducted in a subset of ∼100 patients. Separately, secondary data will be retrospectively captured from >2 000 000 patients with CKD, extracted from existing datasets and registries. RESULTS: The DISCOVER CKD program captures and will report on patient demographics, biomarker and laboratory measurements, medical histories, clinical outcomes, healthcare resource utilization, medications, dietary patterns, physical activity and PROs (including QoL and qualitative interviews). CONCLUSIONS: The DISCOVER CKD program will provide contemporary real-world insight to inform clinical practice and improve our understanding of the epidemiology and clinical and economic burden of CKD, as well as determinants of clinical outcomes and PROs from a range of geographical regions in a real-world CKD setting.

Low Serum Potassium Levels and Clinical Outcomes in Peritoneal Dialysis-International Results from PDOPPS.

INTRODUCTION: Hypokalemia, including normal range values <4 mEq/l, has been associated with increased peritonitis and mortality in patients with peritoneal dialysis. This study sought to describe international variation in hypokalemia, potential modifiable hypokalemia risk factors, and the covariate-adjusted relationship of hypokalemia with peritonitis and mortality. METHODS: Baseline serum potassium was determined in 7421 patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (2014-2017). Association of baseline patient and treatment factors with subsequent serum potassium <4 mEq/l was evaluated by logistic regression, whereas baseline serum potassium levels (4-month average and fraction of 4 months having hypokalemia) on clinical outcomes was assessed by Cox regression. RESULTS: Hypokalemia was more prevalent in Thailand and among black patients in the United States. Characteristics/treatments associated with potassium <4 mEq/l included protein-energy wasting indicators, lower urine volume, lower blood pressure, higher dialysis dose, greater diuretic use, and not being prescribed a renin-angiotensin system inhibitor. Persistent hypokalemia (all 4 months vs. 0 months over the 4-month exposure period) was associated with 80% higher subsequent peritonitis rates (at K <3.5 mEq/l) and 40% higher mortality (at K <4.0 mEq/l) after extensive case mix/potential confounding adjustments. Furthermore, adjusted peritonitis rates were higher if having mean serum K over 4 months <3.5 mEq/l versus 4.0-4.4 mEq/l (hazard ratio, 1.15 [95% confidence interval, 0.96-1.37]), largely because of Gram-positive/culture-negative infections. CONCLUSIONS: Persistent hypokalemia is associated with higher mortality and peritonitis even after extensive adjustment for patient factors. Further studies are needed to elucidate mechanisms of these poorer outcomes and modifiable risk factors for persistent hypokalemia.

A real-world longitudinal study of anemia management in non-dialysis-dependent chronic kidney disease patients: a multinational analysis of CKDopps.

Previously lacking in the literature, we describe longitudinal patterns of anemia prescriptions for non-dialysis-dependent chronic kidney disease (NDD-CKD) patients under nephrologist care. We analyzed data from 2818 Stage 3-5 NDD-CKD patients from Brazil, Germany, and the US, naïve to anemia medications (oral iron, intravenous [IV] iron, or erythropoiesis stimulating agent [ESA]) at enrollment in the CKDopps. We report the cumulative incidence function (CIF) of medication initiation stratified by baseline characteristics. Even in patients with hemoglobin (Hb) < 10 g/dL, the CIF at 12 months for any anemia medication was 40%, and 28% for ESAs. Patients with TSAT < 20% had a CIF of 26% and 6% for oral and IV iron, respectively. Heart failure was associated with earlier initiation of anemia medications. IV iron was prescribed to < 10% of patients with iron deficiency. Only 40% of patients with Hb < 10 g/dL received any anemia medication within a year. Discontinuation of anemia treatment was very common. Anemia treatment is initiated in a limited number of NDD-CKD patients, even in those with guideline-based indications to treat. Hemoglobin trajectory and a history of heart failure appear to guide treatment start. These results support the concept that anemia is sub-optimally managed among NDD-CKD patients in the real-world setting.

Drug treatment patterns and work productivity in chronic kidney disease patients with anemia in China: Cross sectional analysis of real-world data.

BACKGROUND: We explored the association of anemia severity in patients with chronic kidney disease (CKD) and anemia treatment with work productivity in China. METHODS: Cross-sectional survey data from Chinese physicians and their CKD patients were collected in 2015. Physicians recorded demographics, disease characteristics, and treatment. Patients completed the Work Productivity and Activity Impairment questionnaire. Data were stratified by dialysis-dependence, hemoglobin (Hb) level, and anemia treatment. RESULTS: Based on data from 1,052 patients (704 non-dialysis-dependent [NDD] and 348 dialysis-dependent [DD] patients), prescribed anemia treatment differed significantly across Hb levels (P < 0.001). In NDD patients, anemia treatment also differed significantly by on-treatment Hb level (P < 0.001). In treated NDD patients with Hb < 10 g/ dL, Hb 10 to 12 g/dL, and Hb > 12 g/dL, 31%, 59%, and 38% of patients, respectively, were prescribed oral iron, and 34%, 19%, and 0% of patients, respectively, were prescribed oral iron with erythropoiesis-stimulating agents (ESA). NDD patients were less likely to be prescribed any anemia treatment, and ESA specifically, than DD patients. When treated, 67% and 45% of NDD and DD patients, respectively, had Hb ≥ 10 g/dL (P < 0.001). Overall work and activity impairment differed significantly across Hb levels in NDD and DD patients, with the least impairment observed at the highest Hb level. CONCLUSION: Approximately 40% of NDD patients and 60% of DD patients receiving anemia treatment had Hb < 10 g/dL. Compared with mild anemia patients, severe anemia patients were more likely to be treated for anemia and have impaired work productivity. Chinese CKD patients could benefit from improved anemia treatment.

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials.

RATIONALE & OBJECTIVE: The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. STUDY DESIGN: Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. SETTING & STUDY POPULATIONS: Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. SELECTION CRITERIA FOR STUDIES: Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. DATA EXTRACTION: 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. ANALYTIC APPROACH: Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. RESULTS: 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, -40.84 [95% CI, -48.09 to-33.59] g/long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (-0.50 [95% CI, -1.19 to 0.18] mmol/L; low certainty) and hemoglobin A1c levels (-0.14% [95% CI, -0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. LIMITATIONS: Trial quality was variable. The follow-up period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. CONCLUSIONS: Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and cost-effectiveness associated with icodextrin is needed.

Patient-reported advantages and disadvantages of peritoneal dialysis: results from the PDOPPS.

BACKGROUND: Patient-reported measures are increasingly recognized as important predictors of clinical outcomes in peritoneal dialysis (PD). We sought to understand associations between patient-reported perceptions of the advantages and disadvantages of PD and clinical outcomes. METHODS: In this cohort study, 2760 PD patients in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) completed a questionnaire on their PD experience, between 2014 and 2017. In this questionnaire, PDOPPS patients rated 17 aspects of their PD experience on a 5-category ordinal scale, with responses scored from - 2 (major disadvantage) to + 2 (major advantage). An advantage/disadvantage score (ADS) was computed for each patient by averaging their response scores. The ADS, along with each of these 17 aspects, were used as exposures. Outcomes included mortality, transition to hemodialysis (HD), patient-reported quality of life (QOL), and depression. Cox regression was used to estimate associations between ADS and mortality, transition to HD, and a composite of the two. Logistic regression with generalized estimating equations was used to estimate cross-sectional associations of ADS with QOL and depression. RESULTS: While 7% of PD patients had an ADS < 0 (negative perception of PD), 59% had an ADS between 0 and < 1 (positive perception), and 34% had an ADS ≥1 (very positive perception). Minimal association was observed between mortality and the ADS. Compared with a very positive perception, patients with a negative perception had a higher transition rate to HD (hazard ratio [HR] = 1.67; 95% confidence interval [CI]: 1.21, 2.30). Among individual items, "space taken up by PD supplies" was commonly rated as a disadvantage and had the strongest association with transition to HD (HR = 1.28; 95% CI 1.07, 1.53). Lower ADS was strongly associated with worse QOL rating and greater depressive symptoms. CONCLUSIONS: Although patients reported a generally favorable perception of PD, patient-reported disadvantages were associated with transition to HD, lower QOL, and depression. Strategies addressing these disadvantages, in particular reducing solution storage space, may improve patient outcomes and the experience of PD.

The Association of Functional Status with Mortality and Dialysis Modality Change: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

BACKGROUND: Little is known about the prevalence of functional impairment in peritoneal dialysis (PD) patients, its variation by country, and its association with mortality or transfer to hemodialysis. METHODS: A prospective cohort study was conducted in PD patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) (2014 - 2017). Functional status (FS) was assessed by combining self-reports of 8 instrumental and 5 basic activities of daily living, using the Lawton-Brody and the Katz questionnaires. Summary FS scores, ranging from 1.25 (most dependent) to 13 (independent), were based on the patient's ability to perform each activity with or without assistance. Logistic regression was used to estimate the odds ratio (OR; 95% confidence interval [CI]) of a FS score < 11 comparing each country with the United States (US). Cox regression was used to estimate the hazard ratio (HR; 95% CI) for the effect of a low FS score on mortality and transfer to hemodialysis, adjusting for case mix. RESULTS: Of 2,593 patients with complete data on FS, 48% were fully independent (FS = 13), 32% had a FS score 11 to < 13, 14% had a FS score 8 to < 11, and 6% had a FS score < 8. Relative to the US, low FS scores (< 11; more dependent) were more frequent in Thailand (OR = 10.48, 5.90 - 18.60) and the United Kingdom (UK) (OR = 3.29, 1.77 - 6.08), but similar in other PDOPPS countries. The FS score was inversely and monotonically associated with mortality but not with transfer to hemodialysis; the HR, comparing a FS score < 8 vs 13, was 4.01 (2.44 - 6.61) for mortality and 0.91 (0.58 - 1.43) for transfer to hemodialysis. CONCLUSION: Regional differences in FS scores observed across PDOPPS countries may have been partly due to differences in regional patient selection for PD. Functional impairment was associated with mortality but not with permanent transfer to hemodialysis.

The role of icodextrin in peritoneal dialysis: protocol for a systematic review and meta-analysis.

BACKGROUND: Previous meta-analyses have found several advantages of icodextrin compared with glucose in the application of peritoneal dialysis (PD), such as an improvement of peritoneal ultrafiltration during the long dwell and a reduction in episodes of uncontrolled fluid overload. However, the effect of icodextrin on patient-relevant outcomes remains unclear. This review aims to evaluate the benefits and harms of icodextrin in comparison with conventional glucose PD solution in patients with end-stage kidney disease receiving PD. METHODS: Randomized controlled trials of icodextrin comparing with conventional glucose solution in patients with end-stage kidney disease who received PD will be deemed eligible. We will conduct systematic searches in MEDLINE, EMBASE, CENTRAL, Ichushi-Web, Chinese and Japanese databases, and in clinical trials registries (ClinicalTrials.gov, International Clinical Trials Registry Platform Search Portal (ICTRP), EU Clinical Trials Register, Japan Registries Network (JPRN), China's Clinical Trial Registry (ChiCTR)). Furthermore, we will check conference proceedings and search references from relevant studies manually. Relevant pharmaceutical companies, authors, and experts will be contacted in an effort to identify further studies. We will not apply any limitations regarding language, publication status, and publication date when searching for eligible studies. The selection of studies, data extraction, and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan 5 software with either a fixed effects model or random-effects model, depending on the presence of heterogeneity. For the assessment of statistical heterogeneity, I2 will be calculated. Sources of clinical heterogeneity will be evaluated through subgroup analyses. If there are ten or more studies included in the meta-analysis, we will investigate the publication bias using funnel plots and Egger's test. The quality of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. DISCUSSION: We assume that our systematic review will be more comprehensive compared to those published previously due to contacting the relevant pharmaceutical companies and a systematic search of published and unpublished non-English studies from China, Taiwan, and Japan. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096951.

Transition Between Different Renal Replacement Modalities: Gaps in Knowledge and Care-The Integrated Research Initiative.

Patients with end-stage kidney disease (ESKD) have different options to replace the function of their failing kidneys. The "integrated care" model considers treatment pathways rather than individual renal replacement therapy (RRT) techniques. In such a paradigm, the optimal strategy to plan and enact transitions between the different modalities is very relevant, but so far, only limited data on transitions have been published. Perspectives of patients, caregivers, and health professionals on the process of transitioning are even less well documented. Available literature suggests that poor coordination causes significant morbidity and mortality.This review briefly provides the background, development, and scope of the INTErnational Group Research Assessing Transition Effects in Dialysis (INTEGRATED) initiative. We summarize the literature on the transition between different RRT modalities. Further, we present an international research plan to quantify the epidemiology and to assess the qualitative aspects of transition between different modalities.

Patient-Centric User-Interface in Automated Peritoneal Dialysis: Impact on Training and Outcomes at a Single Center.

BACKGROUND: AMIA cycler is a new automated peritoneal dialysis (APD) system, which was approved by FDA in 2015, which is more patient centric due to its features of voice guidance and touch screen. We retrospectively studied if these patient-centric features translated into better patient outcomes. METHODS: We compared 18 patients on AMIA cycler to 18 patients on conventional APD system. Data regarding training duration, dialysis adequacy, laboratory data, and peritonitis incidence were obtained using chart review and compared between the 2 groups. RESULTS: The AMIA group had 33% reduction in the duration of training period compared to the conventional group. All other end points including dialysis adequacy, electrolytes, peritonitis incidence, exit site infections, and dropout rates were not found to be different between both the groups. CONCLUSION: AMIA cycler is superior to the conventional cycler in significantly reducing the training time while having similar clinical outcomes. Further studies are needed to validate this data.

Number of Daily Peritoneal Dialysis Exchanges and Mortality Risk in a Chinese Population.

BACKGROUND: We report outcomes on ≥ 4 compared with < 4 exchanges/day in a Chinese cohort on continuous ambulatory peritoneal dialysis (CAPD). METHODS: Data were sourced from the Baxter (China) Investment Co. Ltd Patient Support Program database, comprising an inception cohort commencing CAPD between 1 January 2005 and 13 August 2015. We used cause-specific Cox proportional hazards and Fine-Gray competing risks (kidney transplantation, change to hemodialysis) models to estimate mortality risk on ≥ 4 compared with < 4 exchanges/day. We matched or adjusted for age, gender, employment, insurance, primary renal disease, size of CAPD program, year of dialysis inception, and treatment center. RESULTS: We modeled 100,022 subjects from 1,177 centers over 239,876 patient-years. Of these subjects, 43,185 received < 4 exchanges/day and 56,837 ≥ 4 exchanges/day. The proportion of patients on < 4 exchanges/day varied widely between centers. Those on < 4 exchanges/day were significantly older, more often female, of unknown employment, and from rural China. In the various models, ≥ 4 exchanges/day was associated with a significantly lower risk of death by 30% - 35% compared with < 4 exchanges/day. This beneficial effect was greatest in younger and rural patients. CONCLUSIONS: In this Chinese CAPD cohort, ≥ 4 exchanges/day was associated with significantly lower mortality risk than < 4 exchanges/day. Analyses are limited by residual confounding from unavailability of important prognostic covariates (e.g., comorbidity, socioeconomic factors) and data on residual renal function, peritoneal clearance, and transport status with which to judge the clinical appropriateness of CAPD prescription. Nonetheless, our study indicates this area as a high priority for further detailed study.

Center-Specific Risk-Adjusted Standardized Mortality Rates on Continuous Ambulatory Peritoneal Dialysis in China.

BACKGROUND: The aim of this study was to determine if there were centers in China with unusually high levels of risk-adjusted mortality in continuous ambulatory peritoneal dialysis (CAPD) patients. METHODS: We analyzed an inception cohort commencing CAPD between 1 January 2005 and 13 August 2015, followed until death, dropout defined as discontinuation of Baxter products, loss to follow-up, or 13 November 2015, whichever occurred first. We calculated standardized mortality ratios (SMRs) from Cox proportional hazards models, adjusting for age, gender, employment status, insurance status, primary renal disease, size of peritoneal dialysis (PD) program, and year of dialysis inception. We calculated 2 SMRs, 1 from models including a fixed effect for center of treatment, and 1 from stratified models. RESULTS: In this study, there was a 9.9% annual mortality rate in China, with decreasing mortality risk over time. There was significant variation of outcomes between Chinese centers, with up to 20% of facilities having SMRs indicating a higher risk-adjusted mortality rate than average. In particular, larger centers had better than expected mortality than smaller ones. There was significant misclassification of SMRs calculated using stratification versus fixed-effects models, although both showed directionally similar results. CONCLUSION: Despite overall satisfactory and improving outcomes, our study showed a significant proportion of PD centers with higher than expected mortality. This is a signal for further assessment of these centers in China, after which there might be a range of actions taken depending on the results of the assessment and context, bearing in mind that the variation seen may be driven by factors unrelated to quality of care or beyond the control of hospital.

The Effect of Automated Versus Continuous Ambulatory Peritoneal Dialysis on Mortality Risk In China.

BACKGROUND: There is an emerging practice pattern of automated peritoneal dialysis (APD) in China. We report on outcomes compared to continuous ambulatory peritoneal dialysis (CAPD) in a Chinese cohort. METHODS: Data were sourced from the Baxter Healthcare (China) Investment Co. Ltd Patient Support Program database, comprising an inception cohort commencing PD between 1 January 2005 and 13 August 2015. We used time-dependent cause-specific Cox proportional hazards and Fine-Gray competing risks (kidney transplantation, change to hemodialysis) models to estimate relative mortality risk between APD and CAPD. We adjusted or matched for age, gender, employment, insurance, primary renal disease, size of PD program, and year of dialysis inception. We used cluster robust regression to account for center effect. RESULTS: We modeled 100,351subjects from 1,178 centers over 240,803 patient-years. Of these, 368 received APD at some time. Compared with patients on CAPD, those on APD were significantly younger, more likely to be male, employed, self-paying, and from larger programs. Overall, APD was associated with a hazard ratio (HR) for death of 0.79 (95% confidence interval [CI] 0.64 - 0.97) compared with CAPD in Cox proportional hazards models, and 0.76 (0.62 - 0.95) in Fine-Gray competing risks regression models. There was prominent effect modification by follow-up time: benefit was observed only up to 4 years follow-up, after which risk of death was similar. CONCLUSION: Automated peritoneal dialysis is associated with an overall lower adjusted risk of death compared with CAPD in China. Analyses are limited by the likelihood of important selection bias arising from group imbalance, and residual confounding from unavailability of important clinical covariates such as comorbidity and Kt/V.

Biocompatibility of a new PD solution for Japan, Reguneal™, measured as in vitro proliferation of fibroblasts.

BACKGROUND: The aim of this study was to investigate in vitro biocompatibility of Reguneal™, a new bicarbonate containing peritoneal dialysis fluid (PDF) for Japan, and compare it with other PDFs available in that country. METHODS: We assessed basal cytotoxicity using in vitro proliferation of cultured fibroblasts, L-929, determining the quantity of living cells by the uptake of Neutral Red. Levels of ten glucose degradation products (GDPs) were measured by a validated ultrahigh-performance liquid chromatography method in combination with an ultraviolet detector. We compared inhibition of fibroblast cell growth between brands of PDF, adjusting for dextrose and GDP concentrations using random-effects mixed models. RESULTS: The results demonstrate that cytotoxicity of Reguneal™ is comparable to a sterile-filtered control and is less cytotoxic than most of the other PDFs, most of which significantly inhibited cell growth. As a "class effect", increasing dextrose and GDP concentrations were non-significantly but positively associated with cytotoxicity. As a "brand effect", these relationships varied widely between brands, and some PDFs had significant residual effects on basal cytotoxicity through mechanisms that were unassociated with either dextrose or GDP concentration. CONCLUSION: Our study suggests that Reguneal™ is a biocompatible PDF. The results of our study also highlight that dextrose and GDPs are important for biocompatibility, but alone are not a complete surrogate. The results of our study need to be confirmed in other tissue culture models, and should lead to further research on determinants of biocompatibility and the effect of such PDFs on clinical outcomes.

Single Daily Icodextrin Exchange as Initial and Solitary Therapy.

BACKGROUND: Incremental dialysis utilizes gradually increasing dialysis doses in response to declines in residual kidney function, and it is the preferred renal replacement therapy for patients who have just transitioned to end-stage renal disease (ESRD). Incremental peritoneal dialysis (PD) may impose fewer restrictions on patients' lifestyle, help attenuate lifetime peritoneal and systemic exposure to glucose and its degradation products, and minimize connections that could compromise the sterile fluid path. In this study, we utilized a 3-pore kinetic model to assess fluid and solute removal during single daily icodextrin treatments for patients with varying glomerular filtration rates (GFR). METHODS: Single icodextrin exchanges of 8 to 16 hours using 2- and 2.5-L bag volumes were simulated for different patient transport types (i.e., high to low) to predict daily peritoneal ultrafiltration (UF), daily peritoneal sodium removal, and weekly total (peritoneal + residual kidney) Kt/V (Kt/VTotal) for patients with residual renal GFRs ranging from 0 to 15 mL/min/1.73 m2. RESULTS: Daily peritoneal UF varied from 359 to 607 mL, and daily peritoneal Na removal varied from 52 to 87 mEq depending on length of icodextrin exchange and bag volume. Both were effectively independent of patient transport type. All but very large patients (total body water [TBW] > 60 L) were predicted to achieve adequate dialysis (Kt/VTotal ≥ 1.7) with a GFR of 10 mL/min/1.73 m2, and small patients (TBW: 30 L) were predicted to achieve adequate dialysis with a GFR of 6 mL/min/1.73 m2. CONCLUSIONS: A single daily icodextrin exchange can be tailored to augment urea, UF, and Na removal in patients with sufficient residual kidney function (RKF). A solitary icodextrin exchange may therefore be reasonable initial therapy for some incident ESRD patients.