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Effects of Reducing L-Carnitine Supplementation on Carnitine Kinetics and Cardiac Function in Hemodialysis Patients: A Multicenter, Single-Blind, Placebo-Controlled, Randomized Clinical Trial.
Sugiyama, M, Hazama, T, Nakano, K, Urae, K, Moriyama, T, Ariyoshi, T, Kurokawa, Y, Kodama, G, Wada, Y, Yano, J, et al
Nutrients. 2021;(6)
Abstract
L-carnitine (LC) supplementation improves cardiac function in hemodialysis (HD) patients. However, whether reducing LC supplementation affects carnitine kinetics and cardiac function in HD patients treated with LC remains unclear. Fifty-nine HD patients previously treated with intravenous LC 1000 mg per HD session (three times weekly) were allocated to three groups: LC injection three times weekly, once weekly, and placebo, and prospectively followed up for six months. Carnitine fractions were assessed by enzyme cycling methods. Plasma and red blood cell (RBC) acylcarnitines were profiled using tandem mass spectrometry. Cardiac function was evaluated using echocardiography and plasma B-type natriuretic peptide (BNP) levels. Reducing LC administration to once weekly significantly decreased plasma carnitine fractions and RBC-free carnitine levels during the study period, which were further decreased in the placebo group (p < 0.001). Plasma BNP levels were significantly elevated in the placebo group (p = 0.03). Furthermore, changes in RBC (C16 + C18:1)/C2 acylcarnitine ratio were positively correlated with changes in plasma BNP levels (β = 0.389, p = 0.005). Reducing LC administration for six months significantly decreased both plasma and RBC carnitine levels, while the full termination of LC increased plasma BNP levels; however, it did not influence cardiac function in HD patients.
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Acute effects of dietary phosphorus intake on markers of mineral metabolism in hemodialysis patients: post hoc analysis of a randomized crossover trial.
Tsai, WC, Wu, HY, Chiu, YL, Yang, JY, Pai, MF, Wu, YR, Lin, WY, Hung, KY, Chien, KL, Hsu, SP, et al
Renal failure. 2021;(1):141-148
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BACKGROUND Long-term dietary phosphorus excess influences disturbances in mineral metabolism, but it is unclear how rapidly the mineral metabolism responds to short-term dietary change in dialysis populations. METHODS This was a post hoc analysis of a randomized crossover trial that evaluated the short-term effects of low-phosphorus diets on mineral parameters in hemodialysis patients. Within a 9-day period, we obtained a total of 4 repeated measurements for each participant regarding dietary intake parameters, including calorie, phosphorus, and calcium intake, and markers of mineral metabolism, including phosphate, calcium, intact parathyroid hormone (iPTH), intact fibroblast growth factor 23 (iFGF23), and C-terminal fibroblast growth factor 23 (cFGF23). The correlations between dietary phosphorus intake and serum mineral parameters were assessed by using mixed-effects models. RESULTS Thirty-four patients were analyzed. In the fully adjusted model, we found that an increase in dietary phosphorus intake of 100 mg was associated with an increase in serum phosphate of 0.3 mg/dL (95% confidence intervals [CI], 0.2-0.4, p < .001), a decrease in serum calcium of 0.06 mg/dL (95% CI, -0.11 to -0.01, p = .01), an increase in iPTH of 5.4% (95% CI, 1.4-9.3, p = .01), and an increase in iFGF23 of 5.0% (95% CI, 2.0-8.0, p = .001). Dietary phosphorus intake was not related to cFGF23. CONCLUSIONS Increased dietary phosphorus intake acutely increases serum phosphate, iPTH, and iFGF23 levels and decreases serum calcium levels, highlighting the important role of daily fluctuations of dietary habits in disturbed mineral homeostasis in hemodialysis patients.
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Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial.
Youssef, AM, Elghoneimy, HA, Helmy, MW, Abdelazeem, AM, El-Khodary, NM
Medicine. 2021;(51):e28322
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BACKGROUND Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD). METHODS This was a parallel-design, open-label, single-center randomized controlled trial on 46 hypertensive patients on maintenance HD, with no history of CVD. Patients were randomly assigned to receive amlodipine 10 mg/d (n = 23) or bisoprolol 10 mg/d (n = 23). Office-based blood pressure (BP) was targeted to ≤ 140/ 90 mm Hg. The outcome was the change in LVMI and ADMA from baseline to 6 months. RESULTS Baseline demographic and clinical characteristics did not vary between groups. After 6 months of treatment, amlodipine-based therapy induced a greater reduction in LVMI from baseline than bisoprolol-based treatment (35 ± 34.2 vs 9.8 ± 35.9 gm/m2; P = .017). A similar reduction in the mean BP occurred with treatment in both groups. ADMA concentration decreased significantly from baseline in the amlodipine group (0.75 ± 0.73 to 0.65 ± 0.67 nmol/mL; P = .001), but increased nonsignificantly in the bisoprolol group (0.64 ± 0.61 to 0.78 ± 0.64 nmol/mL; P = .052). CONCLUSION This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD. TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT04085562, registered September 2019.
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The impact of intradialytic cycling on the removal of protein-bound uraemic toxins: A randomised cross-over study.
De Vos, C, Lemarcq, L, Dhondt, A, Glorieux, G, Van Biesen, W, Eloot, S
The International journal of artificial organs. 2021;(3):156-164
Abstract
The evidence on impact of intradialytic exercise on the removal of urea, is conflictive. Impact of exercise on kinetics of serum levels of protein-bound uraemic toxins, known to exert toxicity and to have kinetics dissimilar of those of urea, has so far not been explored. Furthermore, if any effect, the most optimal intensity, time point and/or required duration of intradialytic exercise to maximise removal remain obscure. We therefore studied the impact of different intradialytic cycling schedules on the removal of protein-bound uraemic toxins during haemodialysis (HD).This randomised cross-over study included seven stable patients who were dialysed with an FX800 dialyser during three consecutive midweek HD sessions of 240 min: (A) without cycling; (B) cycling for 60 min between 60th and 120th minutes of dialysis; and (C) cycling for 60 min between 150th and 210th minutes, with the same cycling load as in session B. Blood and dialysate flows were respectively 300 and 500 mL/min. Blood was sampled from the blood inlet at different time points, and dialysate was partially collected (300 mL/h). Small water soluble solutes and protein-bound toxins were quantified and intradialytic reduction ratios (RR) and overall removal were calculated per solute.Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR60-120 and RR150-210 for potassium.In conclusion, we add evidence to the existing literature that, regardless of the timing within the dialysis session, intradialytic exercise has no impact on small solute clearance, and demonstrated also a lack of impact for protein-bound solutes.
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Effects of photobiomodulation in salivary glands of chronic kidney disease patients on hemodialysis.
Pavesi, VCS, Martins, MD, Coracin, FL, Sousa, AS, Pereira, BJ, Prates, RA, da Silva, JF, Gonçalves, MLL, Bezerra, CDS, Bussadori, SK, et al
Lasers in medical science. 2021;(6):1209-1217
Abstract
This randomized placebo-controlled trial evaluates the impact of photobiomodulation (PBMT) on the salivary flow and biochemistry of patients with chronic kidney disease (CKD) on hemodialysis. Forty-four patients on hemodialysis self-responded two questionnaires for oral health and salivary gland function perception. The subjects were evaluated for function of salivary glands and randomly allocated to two groups: PBMT group (three irradiations at 808 nm, 100 mW, 142 J/cm2, and 4 J per site); and placebo group. Patients were submitted to non-stimulated and stimulated sialometry and after the treatment at baseline and 14 days. Salivary volume and biochemical of the saliva were analyzed. At baseline, most subjects had self-perception of poor oral health (52.6%) and salivary dysfunction (63.1%). Clinical exam revealed that 47.3% of subjects presented dry mucosa. PBMT promoted increase of the non-stimulated (p = 0.027) and stimulated saliva (p = 0.014) and decrease of urea levels in both non-stimulated (p = 0.0001) and stimulated saliva (p = 0.0001). No alteration was detected in total proteins and calcium analysis. Patients with kidney disease can present alteration in flow, concentrations, and composition of saliva, affecting oral health, but our findings suggest that PBMT is effective to improve hyposalivation and urea levels in saliva of patients with CKD.
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A simplified protocol for individualized regional citrate anticoagulation for hemodialysis: A single-center, randomized clinical study.
Luo, L, Fan, M, Chen, Q, Cheng, J
Medicine. 2021;(8):e24639
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INTRODUCTION The lack of individualized treatment protocols and complicated procedures are important factors limiting the use of regional citrate anticoagulation (RCA) technology in hemodialysis. This study aims to validate the safety and efficacy of a simplified individualized RCA protocol for hemodialysis. MATERIALS AND METHODS From June 2019 to August 2019, 45 patients with active bleeding or bleeding tendency undergoing maintenance hemodialysis in the Nephrology Department of the First Affiliated Hospital of Nanchang University were randomly divided into a modified conventional RCA protocol group with a low-flux dialyzer, a simplified individualized RCA protocol group with a high-flux dialyzer, and a simplified individualized RCA protocol group with a low-flux dialyzer. RESULTS A total of 45 patients were included in this study. The mean age of the patients was 57.38 ± 19.05 years, and 78% were men. Forty-three patients completed 4 hours of hemodialysis, and the median total clotting scores in the 3 groups were 11, 12, and 12. Compared with the modified conventional RCA protocol group with a low-flux dialyzer, the 2 simplified individualized RCA protocol groups had better clotting scores for the dialyzer, arterial bubble trap, and single-pool urea clearance index (spKt/VBUN) and lower costs. Moreover, these parameters did not differ between the 2 simplified individualized RCA protocol groups. No electrolyte or acid-base imbalances or citrate poisoning was observed in any of the 3 groups. Adverse events did not differ significantly among the 3 groups. CONCLUSIONS The simplified individualized RCA protocol is safe, effective, and easy to implement. Therefore, this protocol can be promoted for clinical practice. TRIAL REGISTRATION This study was registered in the Chinese Clinical Study Registry under registration number ChiCTR1900023801.
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Separate and combined effects of cold dialysis and intradialytic exercise on the thermoregulatory responses of hemodialysis patients: a randomized-cross-over study.
Krase, AA, Flouris, AD, Karatzaferi, C, Giannaki, CD, Stefanidis, I, Sakkas, GK
BMC nephrology. 2020;(1):524
Abstract
BACKGROUND The separate and combined effects of intradialytic exercise training (IET) and cold dialysis (CD) on patient thermoregulation remain unknown. This study assessed the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols: a) one typical dialysis (TD) protocol (dialysate temperature at 37 °C), b) one cold dialysis (CD) protocol (dialysate temperature at 35 °C), c) one typical dialysis protocol which included a single exercise bout (TD + E), d) one cold dialysis protocol which included a single exercise bout (CD + E). METHODS Ten hemodialysis patients (57.2 ± 14.9 years) participated in this randomized, cross-over study. Core and skin temperatures were measured using an ingestible telemetric pill and by four wireless iButtons attached on the skin, respectively. Body heat storage (S) calculated using the thermometric method proposed by Burton. RESULTS The TD and TD + E protocols were associated with increased S leading to moderate effect size increases in core body temperature (as high as 0.4 °C). The low temperature of the dialysate during the CD and the CD + E protocols prevented the rise in S and core temperature (p > 0.05), even during the period that IET took place. CONCLUSIONS TD and IET are accompanied by a moderate level of hyperthermia, which can be offset by CD. We recommended that CD or with IET can prevent the excessive rise of S. TRIAL REGISTRATION Clinical Trial Registry number: NCT03905551 ( clinicaltrials.gov ), DOR: 05/04/2019.
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Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial.
Bogataj, Š, Pajek, J, Buturović Ponikvar, J, Pajek, M
BMC nephrology. 2020;(1):352
Abstract
BACKGROUND Exercise has various positive effects on hemodialysis patients. However, there is no clear evidence which type of exercise yields better results. This study aimed to determine the effects of guided functional training added to the intradialytic cycling on dialysis adequacy and biochemical parameters in hemodialysis patients. Additionally, we aimed to investigate if patients could transfer functional exercise to an unsupervised home environment and retain gained improvements. METHODS Randomization was done to a functional training intervention group (INT) (n = 20) or intradialytic cycling control group (CON) (n = 20). The INT attended a pre-dialysis functional training in the first 8 weeks. In the second 8 weeks, they performed functional exercises at unsupervised home environment on non-dialysis days. During the whole study, both groups participated in the intradialytic cycling program. RESULTS Both groups demonstrated a significant increase in dialysis adequacy (Kt/V) in the eight (0.15, 95% CI 0.06 to 0.24; p = 0.003 for INT and 0.21, 95% CI 0.11 to 0.3; p < 0.001 for CON) and the 16th study week (0.13, 95% CI 0.03 to 0.24; p = 0.017 for INT and 0.13, 95% CI 0.03 to 0.22; p = 0.013 for CON) compared to their baseline values with no significant between-group differences. At week eight, the total cholesterol was significantly lowered in the INT (- 0.34 mmol/L, 95% CI - 0.6 to - 0.07; p = 0.016) and remained lower at week 16 (- 0.32 mmol/L, 95% CI - 0.64 to - 0.01; p = 0.049) with no significant changes in the CON. Low-density lipoprotein levels in the INT were significantly reduced after 8 weeks (- 0.35 mmol/L, 95% CI - 0.64 to - 0.06; p = 0.022) and remained reduced after 16 weeks (- 0.28 mmol/L, 95% CI - 0.52 to - 0.03; p = 0.030). There were no significant differences found for albumin, high-density lipoprotein cholesterol, triglycerides, C-reactive protein, and hemoglobin in both groups. CONCLUSIONS We demonstrated that functional training added to intradialytic cycling improved lipid profile and dialysis adequacy. Additionally, the effects of the unsupervised, home-based program were preserved during the second study phase. This study supports the assumption that combined training is more effective compared to solely intradialytic exercise. TRIAL REGISTRATION ClinicalTrials.Gov, NCT03334123 . Registered 07 November 2017.
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Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil.
Pinto, LCS, Andrade, MC, Chaves, RO, Lopes, LLB, Maués, KG, Monteiro, AM, Nascimento, MB, Barros, CAV
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2020;(4):e51-e57
Abstract
OBJECTIVES To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis. METHODS The first stage of the work was the development, installation, and establishment of the instructions to use the phone app as an instrument to aid in the control of fluid and food intake of 52 patients undergoing dialysis. In the second stage, the patients were monitored for 3 months and evaluated using questionnaires to measure the improvement in quality of life (Kidney Disease Quality of Life Instrument) and self-management of disease (Perceived Medical Condition Self-Management Scale) by the app. In addition, laboratory tests were performed before app use and in the first, second, and third months of its use (January to April 2018). Analysis of variance was used to analyze the laboratory data, and a paired Student's t test was used to analyze the responses to the questionnaires and as a posttest (P < .05). RESULTS Among the laboratory test results, serum phosphorus levels showed a significant difference (P < .04) after the app was used. A significant improvement was observed in self-management of the disease according to the Perceived Medical Condition Self-Management Scale questionnaire (P < .03). The usability of the app reached a median score of 9.65 from a total score of 10. CONCLUSION The NefroPortatil app improved the degree of perception of self-care of patients undergoing dialysis with chronic kidney failure, in addition to favoring nutritional control.
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Comparison of zinc acetate hydrate and polaprezinc for zinc deficiency in patients on maintenance hemodialysis: A single-center, open-label, prospective randomized study.
Okamoto, T, Hatakeyama, S, Konishi, S, Okita, K, Tanaka, Y, Imanishi, K, Takashima, T, Saitoh, F, Suzuki, T, Ohyama, C
Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy. 2020;(5):568-577
Abstract
The efficacy and safety of zinc acetate hydrate (ZAH) for zinc supplementation in patients on maintenance hemodialysis (MHD) remains unknown. In this prospective, single-center, open-label, parallel-group trial for MHD patients with serum zinc level <70 μg/dL, we compared ZAH (zinc; 50 mg/day) and polaprezinc (PPZ; zinc; 34 mg/day) beyond 6-month administration in a 1:1 randomization manner. The ZAH and PPZ groups had 44 and 47 patients, respectively. At 3 months, the change rate of serum zinc levels in the ZAH group was significantly higher than that in the PPZ group. Three months after the study, serum copper levels significantly decreased in the ZAH group, but not in the PPZ group. No significant differences were noted in anemia management in either group. ZAH was superior to PPZ in increasing serum zinc levels. Clinicians should note the stronger decline in serum copper levels when using ZAH for MHD patients.