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1.
Modification and Validation of the Phosphate Removal Model: A Multicenter Study.
Zhang, W, Du, Q, Xiao, J, Bi, Z, Yu, C, Ye, Z, Wang, M, Chen, J
Kidney & blood pressure research. 2021;(1):53-62
Abstract
BACKGROUND Our research group has previously reported a noninvasive model that estimates phosphate removal within a 4-h hemodialysis (HD) treatment. The aim of this study was to modify the original model and validate the accuracy of the new model of phosphate removal for HD and hemodiafiltration (HDF) treatment. METHODS A total of 109 HD patients from 3 HD centers were enrolled. The actual phosphate removal amount was calculated using the area under the dialysate phosphate concentration time curve. Model modification was executed using second-order multivariable polynomial regression analysis to obtain a new parameter for dialyzer phosphate clearance. Bias, precision, and accuracy were measured in the internal and external validation to determine the performance of the modified model. RESULTS Mean age of the enrolled patients was 63 ± 12 years, and 67 (61.5%) were male. Phosphate removal was 19.06 ± 8.12 mmol and 17.38 ± 6.75 mmol in 4-h HD and HDF treatments, respectively, with no significant difference. The modified phosphate removal model was expressed as Tpo4 = 80.3 × C45 - 0.024 × age + 0.07 × weight + β × clearance - 8.14 (β = 6.231 × 10-3 × clearance - 1.886 × 10-5 × clearance2 - 0.467), where C45 was the phosphate concentration in the spent dialysate measured at the 45th minute of HD and clearance was the phosphate clearance of the dialyzer. Internal validation indicated that the new model was superior to the original model with a significantly smaller bias and higher accuracy. External validation showed that R2, bias, and accuracy were not significantly different than those of internal validation. CONCLUSIONS A new model was generated to quantify phosphate removal by 4-h HD and HDF with a dialyzer surface area of 1.3-1.8 m2. This modified model would contribute to the evaluation of phosphate balance and individualized therapy of hyperphosphatemia.
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2.
Assessment of dialysis initiation by a fuzzy mathematics equation (ADIFE): a study protocol for a randomised controlled trial.
Chen, J, Liu, Y, Chen, X, Sun, X, Li, W, Yang, W, Li, P, Sun, X, Wang, D, Jiang, H, et al
BMJ open. 2019;(9):e023162
Abstract
INTRODUCTION Starting dialysis early or late both result in a low quality of life and a poor prognosis in patients undergoing haemodialysis. However, there remains no consensus on the optimal timing of dialysis initiation, mainly because of a lack of suitable methods to assess variations in dialysis initiation time. We have established a novel equation named DIFE (Dialysis Initiation based on Fuzzy-mathematics Equation) through a retrospective, multicentre clinical cohort study in China to determine the most suitable timing of dialysis initiation. The predictors of the DIFE include nine biochemical markers and clinical variables that together influence dialysis initiation. To externally validate the clinical accuracy of DIFE, we designed the assessment of DIFE (ADIFE) study as a prospective, open-label, multicentre, randomised controlled trial to assess the clinical outcomes among patients who initiate dialysis in an optimal start dialysis group and a late-start dialysis group, based on DIFE. METHODS AND ANALYSIS A total of 388 enrolled patients with end-stage renal disease will be randomised 1:1 to the optimal start dialysis group, with a DIFE value between 30 and 35, or the late-start dialysis group, with a DIFE value less than 30, using the Randomization and Trial Supply Management system. Participants will be assessed for changes in signs and symptoms, dialysis mode and parameters, biochemical and inflammatory markers, Subjective Global Assessment, Kidney Disease Quality of Life Short Form, Cognitive Assessment, medical costs, adverse events and concomitant medication at baseline, predialysis visiting stage and postdialysis visiting stage, every 12-24 weeks. The following data will be recorded on standardised online electronic case report forms. The primary endpoint is 3-year all-cause mortality. The secondary endpoints include non-fatal cerebrocardiovascular events, annual hospitalisation rate, quality of life, medical costs and haemodialysis related complications. ETHICS AND DISSEMINATION Ethical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Dalian Medical University China (registration no: YJ-KY-2017-119) and the ethics committees of all participating centres. The final results of the ADIFE trial will be presented to the study sponsor, clinical researchers and the patient and public involvement reference group. Findings will be disseminated through peer-reviewed journals, Clinical Practice Guidelines and at scientific meetings. TRIAL REGISTRATION NUMBER ClinicalTrial.gov. Registry (NCT03385902); pre-results.
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3.
Association between predialysis hypermagnesaemia and morbidity of uraemic restless legs syndrome in maintenance haemodialysis patients: a retrospective observational study in Zhejiang, China.
Yang, Y, Ye, H, He, Q, Zhang, X, Yu, B, Yang, J, Chen, J
BMJ open. 2019;(7):e027970
Abstract
OBJECTIVE The aim of the present study was to determine whether the predialysis serum magnesium level was associated with morbidity of uraemic restless legs syndrome (RLS) in maintenance haemodialysis patients. DESIGN A retrospective observational study of morbidity of uraemic RLS was conducted. SETTING Patients on maintenance haemodialysis three times a week. PARTICIPANTS We reviewed 578 patients receiving maintenance haemodialysis for >1 year as our cohort. OUTCOME MEASURES Uraemic RLS was diagnosed according to International RLS Study Group criteria, and hypermagnesaemia was defined as serum magnesium level >1.02 mmol/L. RESULTS The prevalence of uraemic RLS was 14.4% in our study cohort. Univariate analysis indicated that patients with uraemic RLS differed significantly from non-RLS ones in certain demographic and clinical characteristics, including younger age, longer dialysis duration, higher serum parathyroid hormone level and higher prevalence of predialysis hyperphosphataemia and hypermagnesaemia. Binary logistic-regression model analysis indicated that predialysis hypermagnesaemia was independently associated with uraemic RLS and conferred an increase in morbidity of the syndrome (OR=2.024; 95% CI 1.160 to 3.532; p=0.013). Moreover, we found that dialysis duration and predialysis hyperphosphataemia were independently associated with morbidity of uraemic RLS. CONCLUSIONS Our data indicated that the predialysis serum magnesium level was associated with morbidity of uraemic RLS in maintenance haemodialysis patients and that predialysis hypermagnesaemia might serve as an independent risk factor for the syndrome.
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4.
Effect of colestilan on serum phosphorus in dialysis patients: A meta-analysis of the literature.
Zhang, Q, Li, M, Chen, J
Nephrology (Carlton, Vic.). 2016;(3):229-35
Abstract
AIM: To evaluate the efficacy and safety of colestilan as a phosphorus binder in dialysis patients, we performed a meta-analysis of randomized controlled trials. METHODS We retrieved studies that compared colestilan with placebo in the treatment of dialysis patients from Medline, EMBASE, the Cochrane Library and conference proceedings. RESULTS Four studies were included. The treatment durations ranged from 2 to 12 weeks, median 7.5 weeks. Compared with placebo group, colestilan significantly decreased serum phosphorus (WMD, -0.22 mmol/L; 95% CI, -0.33 to -0.12, P < 0.0001), calcium phosphorus product (WMD, -0.70 mmol(2) /L(2) ; 95% CI, -1.06 to -0.35, P = 0.0001), intact PTH (WMD, -5.37 pmol/L; 95% CI, -8.38 to -2.36, P = 0.0005) and LDL cholesterol (WMD, -0.78 mmol/L; 95% CI, -0.85 to -0.71, P < 0.00001). There was no significant difference in serum calcium between the two groups. Colestilan therapy increased gastrointestinal complaints significantly (OR = 4.07, 95% CI: 3.06-6.53, P < 0.00001). Sensitivity analysis was performed by excluding studies with Jadad score of three or 3 g/day colestilan, the results did not change. CONCLUSIONS Short-term administration of colestilan is effective for the treatment of hyperphosphataemia in dialysis patients. Long-term effectiveness and safety needs to be evaluated.
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5.
Inflammation but not dietary macronutrients insufficiency associated with the malnutrition-inflammation score in hemodialysis population.
Chen, J, Peng, H, Xiao, L, Zhang, K, Yuan, Z, Chen, J, Wang, Z, Wang, J, Huang, H
PloS one. 2013;(12):e83233
Abstract
Malnutrition is associated with increased risk of mortality in hemodialysis patients. And insufficient dietary intake is the common cause for malnutrition. So, in order to survey the dietary intake of hemodialysis patients and study the relationship between the dietary feature and nutritional status, a cross-sectional study was performed. 75 hemodialysis patients from South China participated in the dietary intake survey and nutrition assessment. A three-day diet diary record was used to estimate the major dietary macronutrients. Nutritional status was assessed by malnutrition-inflammation score (MIS) in addition to several related anthropometric measurements. Serum albumin, transferrin, and high-sensitivity C-reactive protein (CRP) were measured. Receiver operating characteristic (ROC) curve analysis was used to quantify the assessing value of independent parameters for nutritional status. The results showed that 48% patients were malnourished according to the MIS. The malnourished patients had a lower body mass index (BMI), fat mass (FM), albumin and a higher level of CRP, compared with normal nourished patients (P < 0.05). However, no significant differences of macronutrients (calories, protein, fat, carbohydrates, etc) were found between the two nutrition groups (P > 0.05). The multivariate regression analysis showed that the major macronutrients had no significant association with MIS (P > 0.05). In conclusion, malnutrition is very common in South China hemodialysis population and these data indicated that inflammation but not dietary macronutrients insufficiency might be the candidate cause for malnutrition in hemodialysis population.
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6.
Effect of short-term low-protein diet supplemented with keto acids on hyperphosphatemia in maintenance hemodialysis patients.
Li, H, Long, Q, Shao, C, Fan, H, Yuan, L, Huang, B, Gu, Y, Lin, S, Hao, C, Chen, J
Blood purification. 2011;(1-3):33-40
Abstract
AIM: To evaluate the effects of short-term restriction of dietary protein intake (DPI) supplemented with keto acids on hyperphosphatemia in maintenance hemodialysis (MHD) patients. METHODS Forty MHD patients with uncontrolled hyperphosphatemia were randomized to either low DPI with keto acid-supplemented (sLP) or normal DPI (NP) group for 8 weeks. After 8 weeks, the sLP group was shifted to NP for another 8 weeks. Low-protein diet (LPD) was individualized with total caloric intake 30-35 kcal/kg/day, protein intake of 0.8 g/kg/day and phosphate intake of 500 mg/day. Keto acids were supplied in a dosage of 12 pills per day. Calcium phosphorous metabolism index and nutritional index (serum albumin, total protein, somatometric measurements, 3-day diaries and Mini-Nutritional Assessment score) were recorded. C-reactive protein, CO(2) combining power and Kt/V were measured to evaluate the inflammation, metabolic acidosis and dialysis adequacy, respectively. RESULTS Serum phosphorus level and calcium-phosphate product were significantly decreased at the end of the first 8 weeks in the sLP group compared to the basal value and the NP group (p < 0.001). No difference was observed in C-reactive protein, Kt/V and nutritional index, while CO(2) combining power was significantly higher at week 8 in the sLP group (p < 0.001). CONCLUSION Short-term restriction of DPI supplemented with keto acids could decrease hyperphosphatemia and calcium-phosphate product, while keeping stable nutritional status among MHD patients.
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7.
Meta-analysis comparing sevelamer and calcium-based phosphate binders on cardiovascular calcification in hemodialysis patients.
Zhang, Q, Li, M, Lu, Y, Li, H, Gu, Y, Hao, C, Chen, J
Nephron. Clinical practice. 2010;(4):c259-67
Abstract
BACKGROUND Accelerated cardiovascular calcification often occurs in patients with cardiovascular disease who are on hemodialysis. We performed a meta-analysis to compare the effects of sevelamer hydrochloride and calcium-based phosphate binders on coronary artery calcification, C-reactive protein, alkaline phosphatase and intact parathyroid hormone in patients undergoing hemodialysis. METHODS We used the key words 'sevelamer' and 'Renagel' to retrieve studies from Medline, the Cochrane Library and conference proceedings. The trials searched were evaluated for eligibility and quality, and then the data were abstracted and analyzed. RESULTS We ultimately included 14 studies that enrolled a total of 3,271 patients. There was no difference in coronary artery calcium progression between the calcium and the sevelamer groups. Use of sevelamer, rather than calcium-based phosphate binders, was associated with significantly lower C-reactive protein levels (weighted mean difference (WMD) -1.42; 95% confidence interval (CI) -2.09 to -0.74), higher alkaline phosphatase levels (WMD 22.66; 95% CI 13.81-31.5) and higher intact parathyroid hormone levels (WMD 55.85; 95% CI 14.47-97.24). CONCLUSIONS Treatment with sevelamer did not affect cardiovascular calcification, but there was a trend for lower C-reactive protein levels, higher alkaline phosphatase levels and intact parathyroid hormone levels among sevelamer-treated patients.