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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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Implementation and effectiveness of an intensive education program on phosphate control among hemodialysis patients: a non-randomized, single-arm, single-center trial.
Yin, J, Yin, J, Lian, R, Li, P, Zheng, J
BMC nephrology. 2021;(1):243
Abstract
BACKGROUND Hyperphosphatemia is a common complication in patients on maintenance hemodialysis. Patients' adherence to phosphorus control can be improved by consistent education. However, few studies have focused on the model construction and effects of health education on phosphate control for hemodialysis patients. OBJECTIVE To develop an intensive education program focusing on phosphate control among hemodialysis patients and to analyze the effectiveness of this program. DESIGN A non-randomized, single-arm, single-center trial lasting for 6 months. SETTING This program was conducted in a hemodialysis center in a teaching hospital in Zhuhai, China. PARTICIPANTS Patients on maintenance hemodialysis with hyperphosphatemia. METHODS An intensive hyperphosphatemia control education program lasting for 6 months was conducted among 366 hemodialysis patients applying the First Principles of Instruction model, which focused on mastering four stages: (a) activation of prior experience, (b) demonstration of skills, (c) application of skills and (d) integration of these skills into real-world activities. The controlled percentage of serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders before and after the education program were assessed. RESULTS The proportion of controlled serum phosphorus was significantly increased from 43.5 to 54.9% (P<0.001). The scores on the knowledge of phosphate control were improved significantly from 59.0 ± 18.9 to 80.6 ± 12.4 (P < 0.001). The proportion of high adherence to phosphate binders was increased dramatically from 21.9 to 44.5% (P < 0.001). CONCLUSION The intensive education program can effectively improve serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders among hemodialysis patients. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR2100042017 . Retrospectively registered January 12th, 2021.
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Association between the transtheoretical model approach and sustained intradialytic pedaling exercise: A retrospective cohort study.
Murakami, M, Aoki, T, Sugiyama, Y, Takeuchi, M, Yui, T, Koyama, M, Ichikawa, Y, Yanagisawa, K, Furuhata, S, Ikezoe, M, et al
Medicine. 2021;(42):e27406
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Abstract
The transtheoretical model (TTM) is a promising approach to the promotion of behavior change, but it remains to be established whether there is an association between the TTM approach and intradialytic exercise among patients on hemodialysis (HD) with low motivation to exercise in a real-world setting.This retrospective cohort study, conducted in a regional hospital in Japan, included adult outpatients receiving HD 3 times per week who had never participated in intradialytic pedaling exercise despite the encouragement of the HD personnel. Patients were divided into 2 groups according to HD weekday. Patients undergoing HD on Tuesday, Thursday, and Saturday were encouraged by the HD unit team to exercise during HD based on the TTM (exposure group) and those receiving HD on Monday, Wednesday, and Friday were encouraged to exercise as usual (control group). The primary outcome was sustained intradialytic exercise using a leg ergometer, defined as a total of 72 sessions of 30-minute pedaling exercise (duration of at least 6 months).Overall, 85 patients were included in the analysis (mean age: 67.1 ± 11.9 years, 22% female). Of 33 patients in the exposure group, 10 (30%) maintained intradialytic exercise, compared with 2 of 52 patients (4%) in the control group. Log-binomial regression models with stabilized inverse probability of treatment weighting showed a significant association between the TTM approach and sustained intradialytic exercise (adjusted risk ratio 9.23 [95% confidence interval 2.13-40.00]). There were no exercise-related cardiovascular events.Among patients with low motivation to exercise during HD, use of the TTM approach in clinical practice was associated with sustained intradialytic exercise compared with usual care.
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Standardized Aronia melanocarpa extract regulates redox status in patients receiving hemodialysis with anemia.
Milosavljevic, I, Jakovljevic, V, Petrovic, D, Draginic, N, Jeremic, J, Mitrovic, M, Zivkovic, V, Srejovic, I, Stojic, V, Bolevich, S, et al
Molecular and cellular biochemistry. 2021;(11):4167-4175
Abstract
The aim of our study was to investigate the effects of one-month consumption of polyphenol-rich standardized Aronia melanocarpa extract (SAE) on redox status in anemic hemodialysis patients. The study included 30 patients (Hb < 110 g/l, hemodialysis or hemodiafiltration > 3 months; > 3 times week). Patients were treated with commercially available SAE in a dose of 30 ml/day, for 30 days. After finishing the treatment blood samples were taken to evaluate the effects of SAE on redox status. Several parameters of anemia and inflammation were also followed. After the completion of the treatment, the levels of superoxide anion radical and nitrites significantly dropped, while the antioxidant capacity improved via elevation of catalase and reduced glutathione. Proven antioxidant effect was followed by beneficial effects on anemia parameters (increased hemoglobin and haptoglobin concentration, decreased ferritin and lactate dehydrogenase concentration), but SAE consumption didn't improve inflammatory status, except for minor decrease in C-reactive protein. The consumption of SAE regulates redox status (reduce the productions of pro-oxidative molecules and increase antioxidant defense) and has beneficial effects on anemia parameters. SAE could be considered as supportive therapy in patients receiving hemodialysis which are prone to oxidative stress caused by both chronic kidney disease and hemodialysis procedure. Additionally, it could potentially be a good choice for supplementation of anemic hemodialysis patients. TRN: NCT04208451 December 23, 2019 "retrospectively registered".
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Higher Postdialysis Lactic Acid Is Associated with Postdialysis Fatigue in Maintenance of Hemodialysis Patients.
Zu, Y, Lu, X, Yu, Q, Yu, L, Li, H, Wang, S
Blood purification. 2020;(5):535-541
Abstract
BACKGROUND Postdialysis fatigue (PDF) is not an unusual symptom among hemodialysis (HD) patients; however, its causes remain unclear. The aim of this study was to analyze the factors responsible for PDF in maintenance HD patients. METHODS This was a single-center cross-sectional study conducted between March 2018 and March 2019 at the Department of Blood Purification, Beijing Chao-Yang Hospital, Capital Medical University. One hundred and fifteen HD patients were enrolled. Clinical data on demographics, comorbidities, and the primary cause of end-stage renal disease were obtained by questionnaires. Laboratory data were collected pre- and post-HD. Participants were divided into 3 groups according to PDF degree. RESULTS The prevalence of PDF in participants was 60% (n = 69); 26.09% had mild PDF; and 33.91% had severe PDF. In the severe PDF group, the prevalence of intradialytic hypotension (IDH) was 38.46%, significantly higher than in the no PDF group (no-PDF; 8.70%) and mild-PDF (16.67%; p = 0.01 for both) groups. In the severe-PDF group, Charlson comorbidity index score and ultrafiltration rate were significantly higher than those in the no-PDF group (p = 0.040, p = 0.020, respectively). In the severe-PDF group, postdialysis lactic acid (Lac) level was significantly higher than that in the no-PDF or mild-PDF groups (p = 0.013 for both). And in the severe-PDF group, postdialysis sodium (Na) was significantly lower than that in the no-PDF or mild-PDF groups (p = 0.026 for both). It was shown by unconditional logistic regression analysis that IDH occurrence (OR 3.821, 95% CI 1.330-10.975), ultrafiltration rates (OR 1.142, 95% CI 1.018-1.281), lower postdialysis Na level (OR 0.724, 95% CI 0.556-0.942), and higher postdialysis Lac level (OR 2.465, 95% CI 1.126-5.397) were associated with PDF (p = 0.013, p = 0.024, p = 0.016, and p = 0.024, respectively). CONCLUSIONS The prevalence of PDF was high among our study participants. PDF incidence was correlated with the IDH occurrence and higher postdialysis Lac and lower postdialysis Na levels. The level of Lac was a significant influencing factor for the fatigue of patients. More attention should thus be paid to PDF.
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Effects of L-Carnitine Supplementation in Patients Receiving Hemodialysis or Peritoneal Dialysis.
Kuwasawa-Iwasaki, M, Io, H, Muto, M, Ichikawa, S, Wakabayashi, K, Kanda, R, Nakata, J, Nohara, N, Tomino, Y, Suzuki, Y
Nutrients. 2020;(11)
Abstract
L-carnitine is an important factor in fatty acid metabolism, and carnitine deficiency is common in dialysis patients. This study evaluated whether L-carnitine supplementation improved muscle spasm, cardiac function, and renal anemia in dialysis patients. Eighty Japanese outpatients (62 hemodialysis (HD) patients and 18 peritoneal dialysis (PD) patients) received oral L-carnitine (600 mg/day) for 12 months; the HD patients further received intravenous L-carnitine injections (1000 mg three times/week) for 12 months, amounting to 24 months of treatment. Muscle spasm incidence was assessed using a questionnaire, and cardiac function was assessed using echocardiography. Baseline free carnitine concentrations were relatively low in patients who underwent dialysis for >4 years. Total carnitine serum concentration, free carnitine, and acylcarnitine significantly increased after oral L-carnitine treatment for 12 months, and after intravenous L-carnitine injection. There was no significant improvement in muscle spasms, although decreased muscle cramping after L-carnitine treatment was reported by 31% of patients who had undergone HD for >4 years. Hemoglobin concentrations increased significantly at 12 and 24 months in the HD group. Therefore, L-carnitine may be effective for reducing muscle cramping and improving hemoglobin levels in dialysis patients, especially those who have been undergoing dialysis for >4 years.
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Implementation of a decision aid for recognition and correction of volume alterations (Recova®) in haemodialysis patients.
Stenberg, J, Lindberg, M, Furuland, H
Upsala journal of medical sciences. 2020;(4):281-292
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Abstract
BACKGROUND Fluid overload is associated with mortality in haemodialysis patients, and 30% of patients remain fluid-overloaded after dialysis. The aim of this study was to evaluate if implementation of Recova®, a decision aid combining clinical assessment with bioimpedance spectroscopy, facilitates individualization of target weight determination and thereby contributes to improved fluid status in maintenance haemodialysis patients. METHODS The impact of the implementation was measured as the proportion of participants at an adequate target weight at the end of the study, assessed as change in symptoms, hydration status, and N-terminal pro-brain natriuretic peptide (NT-proBNP). Nurses were instructed to use Recova every 2 weeks, and the process of the intervention was measured as frequencies of fluid status assessments, bioimpedance measurements, and target weight adjustments. RESULTS Forty-nine patients at two haemodialysis units were enrolled. In participants with fluid overload (n = 10), both overhydration and fluid overload symptom score decreased. In fluid-depleted participants (n = 20), target weight adjustment frequency and the estimated target weight increased. The post-dialytic negative overhydration was reduced, but NT-proBNP increased. CONCLUSIONS Implementation of Recova in haemodialysis care increased the monthly frequencies of bioimpedance measurements and target weight adjustments, and it contributed to symptom reduction. TRIAL REGISTRATION The Uppsala County Council Registry of Clinical Trials: FoU 2019-0001-15.
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Automated individualization of dialysate sodium concentration reduces intradialytic plasma sodium changes in hemodialysis.
Ságová, M, Wojke, R, Maierhofer, A, Gross, M, Canaud, B, Gauly, A
Artificial organs. 2019;(10):1002-1013
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In standard care, hemodialysis patients are often treated with a center-specific fixed dialysate sodium concentration, potentially resulting in diffusive sodium changes for patients with plasma sodium concentrations below or above this level. While diffusive sodium load may be associated with thirst and higher interdialytic weight gain, excessive diffusive sodium removal may cause intradialytic symptoms. In contrast, the new hemodialysis machine option "Na control" provides automated individualization of dialysate sodium during treatment with the aim to reduce such intradialytic sodium changes without the need to determine the plasma sodium concentration. This proof-of-principle study on sodium control was designed as a monocentric randomized controlled crossover trial: 32 patients with residual diuresis of ≤1000 mL/day were enrolled to be treated by high-volume post-dilution hemodiafiltration (HDF) for 2 weeks each with "Na control" (individually and automatically adjusted dialysate sodium concentration) versus "standard fixed Na" (fixed dialysate sodium 138 mmol/L), in randomized order. Pre- and post-dialytic plasma sodium concentrations were determined at bedside by direct potentiometry. The study hypothesis consisted of 2 components: the mean plasma sodium change between the start and end of the treatment being within ±1.0 mmol/L for sodium-controlled treatments, and a lower variability of the plasma sodium changes for "Na control" than for "standard fixed Na" treatments. Three hundred seventy-two treatments of 31 adult chronic hemodialysis patients (intention-to-treat population) were analyzed. The estimate for the mean plasma sodium change was -0.53 mmol/L (95% confidence interval: [-1.04; -0.02] mmol/L) for "Na control" treatments and -0.95 mmol/L (95% CI: [-1.76; -0.15] mmol/L) for "standard fixed Na" treatments. The standard deviation of the plasma sodium changes was 1.39 mmol/L for "Na control" versus 2.19 mmol/L for "standard fixed Na" treatments (P = 0.0004). Whereas the 95% CI for the estimate for the mean plasma sodium change during "Na control" treatments marginally overlapped the lower border of the predefined margin ±1.0 mmol/L, the variability of intradialytic plasma sodium changes was lower during "Na control" versus "standard fixed Na" treatments. Thus, automated dialysate sodium individualization by "Na control" approaches isonatremic dialysis in the clinical setting.
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A phase 1b randomized, placebo-controlled clinical trial with SNF472 in haemodialysis patients.
Salcedo, C, Joubert, PH, Ferrer, MD, Canals, AZ, Maduell, F, Torregrosa, V, Campistol, JM, Ojeda, R, Perelló, J
British journal of clinical pharmacology. 2019;(4):796-806
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A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis.
Warady, BA, Iles, JN, Ariceta, G, Dehmel, B, Hidalgo, G, Jiang, X, Laskin, B, Shahinfar, S, Vande Walle, J, Schaefer, F
Pediatric nephrology (Berlin, Germany). 2019;(3):475-486
Abstract
BACKGROUND This randomized phase 3 study evaluated the efficacy and safety of cinacalcet in children with secondary hyperparathyroidism (SHPT) receiving dialysis. METHODS This study had double-blind and open-label phases. Eligible patients aged 6-< 18 years were randomized to cinacalcet (starting dose ≤ 0.20 mg/kg) or placebo. The primary endpoint was ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH). Secondary endpoints included mean iPTH ≤ 300 pg/mL; percentage change from baseline in corrected total serum calcium, phosphorus, and calcium phosphorus product (Ca × P); and safety. RESULTS The double-blind phase comprised 43 patients (cinacalcet, n = 22; placebo, n = 21). Nineteen months into the study, regulatory authorities were notified of a fatality; the study was subsequently terminated after a 14-month clinical hold. Before the hold, 12 patients (55%) on cinacalcet and four (19%) on placebo achieved the primary endpoint (p = 0.017), and 27% and 24%, respectively, achieved iPTH ≤ 300 pg/mL. The between-group differences (95% CI) in percentage changes for total serum calcium, phosphorus, and Ca × P were - 4% (- 9 to 1%), - 6% (- 21 to 8%), and - 10% (- 23 to 3%). The mean maximum actual weight-adjusted daily cinacalcet dosage administered was 0.99 mg/kg/day. Overall, 82% of patients on cinacalcet and 86% on placebo had ≥ 1 treatment-emergent adverse event; the most common were vomiting (32%, 24%, respectively), hypocalcemia (23%, 19%), nausea (18%, 14%), and hypertension (14%, 24%). CONCLUSIONS Despite early termination, efficacy and safety outcomes observed with cinacalcet in children with SHPT on dialysis were consistent with adult observations, suggesting cinacalcet may meet an unmet medical need for this population.