The influencing factors of the erythropoietin resistance index and its association with all-cause mortality in maintenance hemodialysis patients.

Anemia is a common complication of chronic kidney disease with major option treatment of erythropoiesis-stimulating agents (ESAs). This study aimed to investigate the influencing factors of erythropoietin resistance index (ERI) and its association with mortality in maintenance hemodialysis (MHD) patients. Patients enrolled from China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5 were included. ERI was calculated as follows: ESA (IU/week)/weight (kg, post-dialysis)/hemoglobin level (g/dL). The Cox regression model was used to analyze the influencing factors on survival outcomes. Stepwise multivariate logistic regression was used to identify the related risk factors, and subgroup analyses were performed. A total of 1270 MHD subjects (687 males and 583 females) were included, with an average age of 60 (49.0, 71.0) years. All subjects were divided into two groups by the median ERI of 14.03. Multivariate logistic regression showed that dialysis vintage (OR 0.957, 95% CI: 0.929-0.986), white blood cells (OR 0.900, 95% CI: 0.844-0.960), high flux dialyzer use (OR 0.866, 95% CI: 0.755-0.993), body mass index (OR 0.860, 95% CI: 0.828-0.892), males (OR 0.708, 95% CI: 0.625-0.801), and albumin (OR 0.512, 95% CI: 0.389-0.673) had a negative association with high ERI baseline (all p < 0.05). There were 176 (13.9%) deaths in total including 89 cardiac/vascular deaths during follow-up. Cox regression analysis showed that ERI was positively associated with all-cause mortality, especially in some subgroups. ERI was associated with increased all-cause mortality in MHD patients, indicating the possibility of death prediction by ERI. Patients with high ERI warrant more attention.

Mortality prediction with adaptive feature importance recalibration for peritoneal dialysis patients.

The study aims to develop AICare, an interpretable mortality prediction model, using electronic medical records (EMR) from follow-up visits for end-stage renal disease (ESRD) patients. AICare includes a multichannel feature extraction module and an adaptive feature importance recalibration module. It integrates dynamic records and static features to perform personalized health context representation learning. The dataset encompasses 13,091 visits and demographic data of 656 peritoneal dialysis (PD) patients spanning 12 years. An additional public dataset of 4,789 visits from 1,363 hemodialysis (HD) patients is also considered. AICare outperforms traditional deep learning models in mortality prediction while retaining interpretability. It uncovers mortality-feature relationships and variations in feature importance and provides reference values. An AI-doctor interaction system is developed for visualizing patients' health trajectories and risk indicators.

Clinical Outcomes in Patients on Hemodialysis with Congestive Heart Failure.

Introduction: Congestive heart failure (CHF) is one of the common complications in patients with end-stage kidney disease. In the general population, CHF increases the risk of the death. However, there is no well-designed relevant study in the Chinese hemodialysis (HD) population addressing the risks associated with CHF. The aim of this study was to explore the impact of CHF on clinical outcomes in HD patients. Methods: Data from a prospective cohort study, the China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5 (2012-2015), were analyzed. Demographic data, comorbidities, lab data, and death records were extracted. CHF was defined by the diagnosis records upon study inclusion. Our primary outcome was all-cause and cardiovascular (CV) mortality; secondary outcomes were all-cause and cause-specific hospitalization risk. Associations between CHF and outcomes were evaluated using Cox regression models. Stepwise multivariate logistic regression was used to identify the related risk factors, and subgroup analyses were carried out. Results: Of 1,411 patients without missing CHF history information, 24.1% (340) had CHF diagnosis at enrollment. The overall mortality rates were 21.8% versus 12.0% (p < 0.001) in patients with and without CHF during follow-up, respectively. CHF was associated with higher all-cause mortality (adjusted HR: 1.72, 95% confidence interval [CI]: 1.17-2.53, p = 0.006), and the association with CV death was of similar magnitude (HR: 1.60, 95% CI: 0.91-2.81, p = 0.105). CHF patients had more episodes of hospitalization due to heart failure (HR: 2.93, 95% CI: 1.49-5.76, p < 0.01). However, compared with patients without CHF, the all-cause hospitalization risk was not much higher in CHF patients (HR: 1.09, 95% CI: 0.90-1.33, p = 0.39). Subgroup analysis found that the effect of CHF on all-cause mortality was stronger for male patients, patients with residual renal function, the elderly (≥60 years of age), patients with arteriovenous fistulae vascular accesses, nondiabetic patients, low-flux dialyzer users, and inadequately dialyzed patients (standardized Kt/V <2). Conclusion: In HD patients, CHF was found to be associated with a higher risk of all-cause mortality and cause-specific hospitalization risk. Further research is needed to identify opportunities to improve care for HD patients combined with CHF.

Multicentre, observational, retrospective cohort of hyperkalaemia burden at haemodialysis facility-level in China: the Visualize-HD study protocol.

OBJECTIVES: Hyperkalaemia is a potentially life-threatening disorder in patients undergoing haemodialysis (HD). Excess mortality and hospitalisation have been associated with hyperkalaemia (HK) after the long (2-day) interdialytic interval (LIDI) in patients on thrice a week HD compared with the short (1-day) interdialytic interval. Moreover, not much research has been conducted in China on the descriptive epidemiology and management of HK among different HD centres. The aim of this study is to address this evidence gap by investigating the risk factors associated with HK clinical burden at the HD facility level, current HD centres management patterns, serum potassium management patterns, as well as the risk factors associated with crude mortality in China. DESIGN: Multicentre, observational, retrospective cohort study. SETTING: This study plans to enrol 300 HD centres across China. Haemodialysis centres having ≥100 patients on maintenance HD within 3 years before study initiation, with participation willingness, routine blood collection post-LIDI and death records will be included. PARTICIPANTS: Patients aged ≥18 years and on chronic HD for ≥3 months will be considered eligible. Summary data about serum potassium, characteristics of patients, facility practice patterns will be collected at HD facility level and death records will be at the patient level. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome will be to examine the association between suspected risk factors and HK prevalence at HD facility level. Suspected risk factors include dialysis prescriptions and serum potassium testing frequency, characteristics of patients and related medication usage. The secondary outcome will be to determine the HK prevalence, serum potassium management pattern and risk factors associated with crude mortality. The primary and secondary outcomes will be analysed using regression models. Exploratory outcomes will further investigate the risk factors associated with serum potassium ≥6.0 and ≥6.5 mmol/L. CONCLUSION: The study is expected to provide insights to improve dialysis practice patterns and understand the clinical burden of HK. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the Institutional Review Boards and Ethics Committee of Peking University People's Hospital (Approval number: 2020PHB324-01). The results will be disseminated through national and international presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05020717.

High facility-level serum potassium variability associated with mortality in hemodialysis patients: results from Chinese Dialysis Outcomes and Practice Patterns Study (DOPPS).

The role of facility-level serum potassium (sK+) variability (FL-SPV) in dialysis patients has not been extensively studied. This study aimed to evaluate the association between FL-SPV and clinical outcomes in hemodialysis patients using data from the China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5. FL-SPV was defined as the standard deviation (SD) of baseline sK+ of all patients in each dialysis center. The mean and SD values of FL-SPV of all participants were calculated, and patients were divided into the high FL-SPV (>the mean value) and low FL-SPV (≤the mean value) groups. Totally, 1339 patients were included, with a mean FL-SPV of 0.800 mmol/L. Twenty-three centers with 656 patients were in the low FL-SPV group, and 22 centers with 683 patients were in the high FL-SPV group. Multivariate logistic regression analysis showed that liver cirrhosis (OR = 4.682, 95% CI: 1.246-17.593), baseline sK+ (<3.5 vs. 3.5 ≤ sK+ < 5.5 mmol/L, OR = 2.394, 95% CI: 1.095-5.234; ≥5.5 vs. 3.5 ≤ sK+ < 5.5 mmol/L, OR = 1.451, 95% CI: 1.087-1.939), dialysis <3 times/week (OR = 1.472, 95% CI: 1.073-2.020), facility patients' number (OR = 1.088, 95% CI: 1.058-1.119), serum HCO3- level (OR = 0.952, 95% CI: 0.921-0.984), dialysis vintage (OR = 0.919, 95% CI: 0.888-0.950), other cardiovascular disease (OR = 0.508, 95% CI: 0.369-0.700), and using high-flux dialyzer (OR = 0.425, 95% CI: 0.250-0.724) were independently associated with high FL-SPV (all p < .05). After adjusting potential confounders, high FL-SPV was an independent risk factor for all-cause death (HR = 1.420, 95% CI: 1.044-1.933) and cardiovascular death (HR = 1.827, 95% CI: 1.188-2.810). Enhancing the management of sK+ of hemodialysis patients and reducing FL-SPV may improve patient survival.

Echocardiographic left ventricular hypertrophy and geometry in Chinese chronic hemodialysis patients: the prevalence and determinants.

BACKGROUND: To investigate the prevalence of left ventricular hypertrophy (LVH) and explore left ventricular geometry in maintenance hemodialysis (MHD) patients, and to explore the risk factors of LVH which is an important predictor of cardiovascular events. METHODS: The subjects were patients who are on MHD for more than 3 months in Peking University People's Hospital from March 2015 to February 2017. Demographic and clinical data were retrospectively collected. Left ventricular mass was measured by echocardiography. LVH is defined by Left ventricular mass index (LVMI) > 115 g/m2 for men and > 95 g/m2 in women. LVMI and relative wall thickness were used to determine left ventricular geometry. Logistic regression was used to analyze the risk factors of LVH. RESULTS: Altogether, 131 patients including 77 males were enrolled. The median age was 60 (47, 69) years, with a median dialysis vintage of 48 (18, 104) months. There were 80 patients with LVH, the prevalence rate was 61.1%, and 66.3% of them were moderate to severe LVH. We found that (1) most of the patients were concentric hypertrophy; (2) one-third of the patients were concentric remodeling; (3) only 4 cases with normal geometry. The pre-dialysis serum sodium level and time average pre-dialysis systolic blood pressure (SBP) were independent risk factors of LVH. CONCLUSION: LVH is prevalent in MHD patients. Concentric hypertrophy and concentric remodeling are the most common geometric patterns. Attention should be paid to long-term pre-dialysis SBP management and pre-dialysis sodium control as they might be potentially modifiable risk factors for LVH.

Thrombocytopenia predicts mortality in Chinese hemodialysis patients- an analysis of the China DOPPS.

BACKGROUND: Hemodialysis (HD) patients have a higher mortality rate compared with general population. Our previous study revealed that platelet counts might be a potential risk factor. The role of platelets in HD patients has rarely been studied. The aim of this study is to examine if there is an association of thrombocytopenia (TP) with elevated risk of all-cause mortality and cardiovascular (CV) death in Chinese HD patients. METHODS: Data from a prospective cohort study, China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5, were analyzed. Demographic data, comorbidities, platelet counts and other lab data, and death records which extracted from the medical record were analyzed. TP was defined as the platelet count below the lower normal limit (< 100*109/L). Associations between platelet counts and all-cause and CV mortality were evaluated using Cox regression models. Stepwise multivariate logistic regression was used to identify the independent associated factors, and subgroup analyses were also carried out. RESULTS: Of 1369 patients, 11.2% (154) had TP at enrollment. The all-cause mortality rates were 26.0% vs. 13.3% (p < 0.001) in patients with and without TP. TP was associated with higher all-cause mortality after adjusted for covariates (HR:1.73,95%CI:1.11,2.71), but was not associated with CV death after fully adjusted (HR:1.71,95%CI:0.88,3.33). Multivariate logistic regression showed that urine output < 200 ml/day, cerebrovascular disease, hepatitis (B or C), and white blood cells were independent impact factors (P < 0.05). Subgroup analysis found that the effect of TP on all-cause mortality was more prominent in patients with diabetes or hypertension, who on dialysis thrice a week, with lower ALB (< 4 g/dl) or higher hemoglobin, and patients without congestive heart failure, cerebrovascular disease, or hepatitis (P < 0.05). CONCLUSION: In Chinese HD patients, TP is associated with higher risk of all-cause mortality, but not cardiovascular mortality. Platelet counts may be a useful prognostic marker for clinical outcomes among HD patients, though additional study is needed.

Blood flow rate: An independent risk factor of mortality in Chinese hemodialysis patients.

BACKGROUND: Studies suggested the association between blood flow rate (BFR) and mortality might be beyond dialysis adequacy. This study aimed to explore if BFR is an independent predictor of clinical outcomes in Chinese hemodialysis (HD) patients. METHODS: This study included data from patients in China Dialysis Outcomes and Practice Patterns Study (DOPPS) Phase 5. Patients with a record of BFR were included, and demographic data, comorbidities, hospitalization, and death records were collected. Associations between BFR and all-cause mortality and hospitalization were analyzed using Cox regression models. RESULTS: One thousand four hundred twelve (98.9%) patients were included. Most patients were with BFR < 300 ml/min. After full adjustment, each 10-ml/min increase of BFR was associated with a 6.4% decrease in all-cause mortality risk (HR: 0.936, 95% CI: 0.880-0.996) but not first hospitalization (HR: 0.987, 95% CI: 0.949-1.027). The impact of BFR on mortality may be more prominent in patients who were male gender, nondiabetic, albumin < 4.0 g/dl, and hemoglobin ≥ 9.0 g/dl. CONCLUSION: Increased BFR is independently associated with a lower risk of all-cause mortality within the range of BFR 200-300 ml/min. And this effect is more pronounced in patients who were male gender, nondiabetic, albumin < 4.0 g/dl, and hemoglobin ≥ 9.0 g/dl.

Physical Function and Clinical Outcomes in Hemodialysis Patients: China Dialysis Outcomes and Practice Patterns Study.

BACKGROUND: Hemodialysis (HD) patients usually have impaired physical function compared with the general population. Self-reported physical function is a simple method to implement in daily dialysis care. This study aimed to examine the association of self-reported physical function with clinical outcomes of HD patients. METHODS: The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective cohort study. Data on 1,427 HD patients in China DOPPS5 were analyzed. Self-reported physical function was characterized by 2 items of "moderate activities limited level" and "climbing stairs limited level." Demographic data, comorbidities, hospitalization, and death records were collected from patients' records. Associations between physical function and outcomes were analyzed using COX regression models. RESULTS: Compared to "limited a lot" in moderate activities, "limited a little" and "not limited at all" groups were associated with lower all-cause mortality after adjusted for covariates (HR: 0.652, 95% CI: 0.435-0.977, and HR: 0.472, 95% CI: 0.241-0.927, respectively). And, not limited in moderate activities was associated with lower risk of hospitalization than the "limited a lot" group after adjusted for covariates (HR: 0.747, 95% CI: 0.570-0.978). Meanwhile, compared to "limited a lot" in climbing stairs, "limited a little" and "not limited at all" groups were associated with lower all-cause mortality (HR: 0.574, 95% CI: 0.380-0.865 and HR: 0.472, 95% CI: 0.293-0.762, respectively) but not hospitalization after fully adjusted. CONCLUSION: Higher limited levels in self-reported physical function were associated with higher risk of all-cause mortality and hospitalization in HD patients.

Secondary hyperparathyroidism, weight loss, and longer term mortality in haemodialysis patients: results from the DOPPS.

BACKGROUND: Wasting is a common complication of kidney failure that leads to weight loss and poor outcomes. Recent experimental data identified parathyroid hormone (PTH) as a driver of adipose tissue browning and wasting, but little is known about the relations among secondary hyperparathyroidism, weight loss, and risk of mortality in dialysis patients. METHODS: We included 42,319 chronic in-centre haemodialysis patients from the Dialysis Outcomes and Practice Patterns Study phases 2-6 (2002-2018). Linear mixed models were used to estimate the association between baseline PTH and percent weight change over 12 months, adjusting for country, demographics, comorbidities, and labs. Accelerated failure time models were used to assess 12 month weight loss as a mediator between baseline high PTH and mortality after 12 months. RESULTS: Baseline PTH was inversely associated with 12 month weight change: 12 month weight loss >5% was observed in 21%, 18%, 18%, 17%, 15%, and 14% of patients for PTH ≥600 pg/mL, 450-600, 300-450, 150-300, 50-150, and <50 pg/mL, respectively. In adjusted analyses, 12 month weight change compared with PTH 150-299 pg/mL was -0.60%, -0.12%, -0.10%, +0.15%, and +0.35% for PTH ≥600, 450-600, 300-450, 50-150, and <50 pg/mL, respectively. This relationship was robust regardless of recent hospitalization and was more pronounced in persons with preserved appetite. During follow-up after the 12 month weight measure [median, 1.0 (interquartile range, 0.6-1.7) years; 6125 deaths], patients with baseline PTH ≥600 pg/mL had 11% [95% confidence interval (CI), 9-13%] shorter lifespan, and 18% (95% CI, 14-23%) of this effect was mediated through weight loss ≥2.5%. CONCLUSIONS: Secondary hyperparathyroidism may be a novel mechanism of wasting, corroborating experimental data, and, among chronic dialysis patients, this pathway may be a mediator between elevated PTH levels and mortality. Future research should determine whether PTH-lowering therapy can limit weight loss and improve longer term dialysis outcomes.

Severe secondary hyperkalemia and arrhythmia from drug interactions between calcium-channel blocker and voriconazole: a case presentation.

BACKGROUND: Patients with kidney disease may have concurrent hypertension and infection. Dihydropyridine calcium-channel blockers (CCB) are the most popular class of antihypertensive drugs used in clinical settings and can be metabolized by cytochrome P450 isoenzyme 3A4 (CYP3A4). Voriconazole is a commonly used antifungal treatment and a CYP3A4-inhibitor. Insufficient attention to drug interactions from the concomitant use of CCB and voriconazole may result in serious adverse reactions. CASE PRESENTATION: Here, we report a patient with acute kidney injury on stable anti-neutrophil cytoplasm antibody associated vasculitis who developed hyperkalemia resulting in sinus arrest with junctional escape rhythm attributed to drug interactions of CCB with voriconazole. This is a very rarely reported case and may be an under-recognized complication. After continuous renal replacement therapy and changing the anti-hypertensive drugs, symptoms, and laboratory abnormalities of the patient fully recovered. CONCLUSIONS: This case warns us of severe consequences of drug interactions. Co-prescription of CYP3A4-inhibitors with calcium-channel blockers increases the risk of hypotension and acute kidney injury, which may further induce hyperkalemia and arrhythmia.

Baseline data report of the China Dialysis Outcomes and Practice Patterns Study (DOPPS).

The number of patients on hemodialysis (HD) is rapidly increasing in China. As an Asian country with a large number of HD patients, understanding the status of Chinese HD patients has a special significance. We reported here the baseline data for China Dialysis Outcomes and Practice Pattern Study Phase 5 (DOPPS5). The DOPPS is an international prospective, observational cohort study. Patients were restricted to the initial sample of patients who participated in China DOPPS5. We summarized the baseline demographic and clinical data of patients. Results were weighted by facility sampling fraction. 1186 patients were initial patients in China DOPPS5. The mean age was 58.7 ± 3.5 years, with 54.6% males. The median dialysis vintage was 3.4 (1.5, 6.3) years. The main assigned primary end-stage kidney disease (ESKD) causes was chronic glomerulonephritis (45.9%), followed by diabetes (19.9%). 17.6% patients had hepatitis B infection, and 10.0% patients had hepatitis C infection. 25.9% patients had a single-pooled Kt/V < 1.2. 86.6% patients had albumin > 3.5 g/dl. 18.8% patients had hemoglobin < 9 g/dl. 66.5% patients had serum calcium in target range (8.4-10.2 mg/dl), 41.5% patients had serum phosphate in target range (3.5-5.5 mg/dl) and 51.2% patients maintained PTH in 150-600 pg/dl. 88.2% patients used fistula as their vascular access. Meanwhile, there were differences in the demographic, clinical, laboratory, and treatment characteristics among the three cities participated in China DOPPS. We observed a relatively higher albumin level and a higher rate of fistula usage in our patients. But it remains a major challenge to us on the management of CKD-MBD and anemia. This study did not include patients in small cities and remote areas, where the situation of HD patients might be worse than reported.

Executive summary for China Kidney Disease Network (CK-NET) 2016 Annual Data Report.

Chronic kidney disease (CKD) has been recognized as a public health problem globally. The spectrum of CKD in China has been evolving toward that of developed countries, which will have enormous impacts on the health care system. However, there has been no well-established national surveillance system for kidney diseases. Furthermore, China still faces several challenges of kidney care, including limited capacity and efficiency, suboptimal awareness, and huge heterogeneity in diagnosis and treatment. The China Kidney Disease Network has published 2 reports regarding the burden of CKD and end-stage kidney disease in China and intends to become a comprehensive surveillance system for kidney diseases based on multisource data. With the expansion of research group and data sources, the content of the China Kidney Disease Network 2016 Annual Data Report was further enriched. Section I addresses the epidemiologic characteristics of patients with CKD based on a national inpatient database, Hospital Quality Monitoring System, covering more than 52% of China's tertiary hospitals in China in 2016. Section II focuses on the burden of patients receiving dialysis, mainly based on the nationwide claims database, China Health Insurance Research Association database, which collects data from approximately 2% of the insured population from the municipalities/provincial capital cities and approximately 5% from the prefecture-level cities. An independent chapter regarding dialysis in 3 provincial dialysis quality control centers has been added. The China Kidney Disease Network 2016 Annual Data Report symbolizes a successful team effort in the era of big data, with support from the specialists and partners of the collaborative network, which is of substantial value for understanding the burden of kidney diseases in China and developing prevention and control strategies.

CKD in China: Evolving Spectrum and Public Health Implications.

Diabetes is the leading cause of kidney failure worldwide, whereas glomerulonephritis has been predominant in developing countries such as China. The prevalence of obesity and diabetes has increased dramatically in developing countries, substantially affecting the patterns of chronic kidney disease (CKD) observed in these regions. Using data from the Hospital Quality Monitoring System to evaluate changes in the spectrum of non-dialysis-dependent CKD in China, we have observed an increase in the percentage of patients with CKD due to diabetes, which has exceeded that of CKD due to glomerulonephritis since 2011, as well as an increase in hypertensive nephropathy and, in some regions, obstructive kidney disease (mostly associated with kidney stones). The growth of noncommunicable diseases under profound societal and environmental changes has shifted the spectrum of CKD in China toward patterns similar to those of developed countries, which will have enormous impacts on the Chinese health care system. There is much to be done regarding public health interventions, including the establishment of a national CKD surveillance system, improvement in the management of diabetes and hypertension, and enhancement of the affordability and accessibility of kidney replacement therapy. Reducing the burden of CKD will require joint efforts from government, the medical community (including practitioners other than nephrologists), and the public.

Effect of Intradialytic Exercise on Physical Performance and Cardiovascular Risk Factors in Patients Receiving Maintenance Hemodialysis: A Pilot and Feasibility Study.

INTRODUCTION: Although intradialytic exercise is considered a form of "nonpharmacological medicine" for patients receiving maintenance hemodialysis (MHD), this practice has not been widely implemented in most dialysis centers because of clinical limitations. We, therefore, aimed to design an intradialytic exercise training program to improve the implementation of this practice and determine its impact on physical performance and cardiovascular risk factors in patients receiving MHD. METHODS: A total of 132 MHD patients at 4 outpatient dialysis units were enrolled and assigned randomly into exercise (n = 67) and control groups (n = 65). During a 2-year period, patients in the exercise group participated in 20-min exercise training sessions within dialysis sessions on 3 days per week. All patients underwent assessments of physical function (6-min walk test) and cardiovascular risk factors (blood pressure [BP], total cholesterol [TC], low-density lipoprotein [LDL], high-sensitivity C-reactive protein [hsCRP], albumin [Alb], hemoglobin [Hb], and erythropoietin [EPO] dose) at the baseline and annually thereafter. RESULTS: Of the participants, 50.8% had completed the study after 2 years. No statistically significant intragroup or intergroup differences were observed in the measures of 6MD, BP, TC, hsCRP, Alb, Hb, and EPO dose. CONCLUSION: The results suggest that although this low-intensity, nonprogressive intradialytic exercise program may be practical, it was not sufficient to improve physiological function and reduce cardiovascular disease risk factors in patients receiving MHD.

Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population.

BACKGROUND: The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population. METHODS: The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18-80 years old, in stable CKD stages 4-5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods. DISCUSSION: This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial. TRIAL REGISTRATION: The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.

Executive summary for the 2015 Annual Data Report of the China Kidney Disease Network (CK-NET).

Chronic kidney disease (CKD) has received increased attention as a leading public health problem worldwide. Globally surveillance systems for kidney disease are still lacking, especially in developing countries like China, which constitutes an obstacle to develop effective preventive strategies. China Kidney Disease Network (CK-NET) was initiated in 2014 and further developed in accordance with the national strategy of prompting Big Data application in China. One major output of CK-NET is to generate an Annual Data Report (ADR) providing resourceful information regarding kidney disease in China. Entering the second cycle of ADR, we have expanded the scope and depth of our research based on the previous ADR. There are 2 sections in the current ADR, generated from data from 2015 from various sources. Section I is based on a dataset of national hospitalized patients and describes the characteristics regarding hospitalized patients with CKD. Section II focuses on patients receiving renal replacement therapy based on 2 nationwide claims databases. There is also a chapter that focuses on patients on the waiting list for renal transplantation based on the China Organ Transplant Response System. Certain findings, including the effect of metabolic disease on the spectrum of CKD, the underdiagnoses of CKD and acute kidney injury among hospitalized patients, and the less-optimal treatment of complications among dialysis patients, will inspire the following research as well as changes in health policy. By integrating and mining national patient-level administrative or claim databases, we are able to provide a comprehensive description of the burden of CKD and end stage kidney disease in China, which could be used by multiple stakeholders with interests in kidney disease.

Early mortality risk in incident Chinese hemodialysis patients: a retrospective cohort study.

BACKGROUND: Early mortality risk of maintenance hemodialysis (MHD) patients varies by country and ethnicity. Here, early mortality in incident Chinese HD patients were studied. METHODS: Data from 1 January 2007 to 31 December 2013 were pulled from Beijing dialysis registry system. All included patients were followed to the end of 2013. This time period of dialysis was divided into six intervals (≤120, 121-365 days; 1-2, 2-3, 3-4, ≥5 years). Patients' demographics, primary cause of end-stage renal disease (ESRD), date of first HD, date of death, cause for death, date and cause of censoring were extracted from the registry database. All-cause mortality (per 100 patient-years) was calculated for each period stratified by sex, age and cause of ESRD. Monthly mortality rates were also calculated. RESULTS: A total of 11,955 patients were included, 6738 were males and 5217 were females. The mean age at dialysis initiation was 57.7 ± 16.1 years. The median follow-up time was 19.8 months. There were total 2555 deaths. The overall mortality rate was 8.2 per 100 patient-years. Mortality rates were 18.7, 7.5, 6.9, 6.9, 6.5 and 6.2 in each period. The first 2 months mortality rates were 41.9 and 16.6 per 100 patient-years. Higher mortality was observed in patients who were older, female, diabetic and hypertensive. CONCLUSIONS: The most critical period was the first 2 months of dialysis initiation. Patients who were older, female, diabetic and hypertensive had higher risk of early mortality. Our analysis highlighted that the transitional period from sever CKD stages to dialysis initiation, when optimal supportive care should be adopted, was crucial for patients' survival.

[Renal damage caused by Rhupus syndrome associated with anti-neutrophil cytoplasmic antibodies vasculitis and cryoglobulinemia].

We analyzed the clinicopathological characteristics of one patient with Rhupus syndrome associated nephropathy in Peking University People's Hospital, and reviewed the related literature. The patient was a middle aged female. She developed rheumatoid arthritis first, and then manifested mild systemic lupus erythematosus together with positive anti-neutrophil cytoplasmic antibodies (ANCA) and cryoglobulinemia several years later. The renal biopsy was performed and manifested as lupus nephritis. The transmission electron microscopy revealed cryoglobulinemia associated renal damage. This report shows that the clinicopathological characteristics in patients with Rhupus syndrome associated nephropathy are complicated. The renal pathology can be used as a diagnostic tool.