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Long-term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients.
Sprague, SM, Ketteler, M, Covic, AC, Floege, J, Rakov, V, Walpen, S, Rastogi, A
Hemodialysis international. International Symposium on Home Hemodialysis. 2018;(4):480-491
Abstract
INTRODUCTION Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill burden, vs. sevelamer carbonate ("sevelamer"), in a Phase 3 study conducted in dialysis patients with hyperphosphatemia. This analysis evaluates the efficacy and safety of SFOH and sevelamer among African American (AA) patients participating in the trial. METHODS Post hoc analysis of a 24-week, Phase 3, open-label trial (NCT01324128) and its 28-week extension study (NCT01464190). Patients were randomized 2:1 to SFOH (1.0-3.0 g/day) or sevelamer (2.4-14.4 g/day) for up to 52 weeks. FINDINGS Of 549 patients who completed the Phase 3 study and extension, 100 (18.2%) AA patients were eligible for efficacy analysis (SFOH, n = 48; sevelamer, n = 52). sP concentrations decreased rapidly and comparably with both treatments by Week 8 (mean ± standard deviation change from baseline: -1.9 ± 1.9 mg/dL for SFOH and -2.2 ± 1.8 mg/dL for sevelamer). These reductions were maintained for 52 weeks (-2.1 ± 2.6 and -2.1 ± 1.6 mg/dL) and achieved with a lower mean pill burden (3.4 ± 1.4 vs. 7.6 ± 2.9 tablets/day) with SFOH vs. sevelamer. Treatment adherence rates (adherence within 70%-120% of expected medication intake) were 79.2% with SFOH and 59.6% with sevelamer. The proportion of patients reporting serious adverse events (AEs) was 27.7% with SFOH and 30.7% with sevelamer. More patients withdrew due to treatment-emergent AEs with SFOH vs. sevelamer (18.5% vs. 8.0%). The most common AEs with both treatments were gastrointestinal-related: diarrhea and discolored feces with SFOH, and nausea, vomiting, and constipation with sevelamer. DISCUSSION SFOH is an efficacious and well-tolerated treatment for hyperphosphatemia in AA dialysis patients, with a lower pill burden and an improved adherence rate vs. sevelamer. These findings were consistent with the wider US patient population and the overall study population.
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Prediction of Arteriovenous Fistula Clinical Maturation from Postoperative Ultrasound Measurements: Findings from the Hemodialysis Fistula Maturation Study.
Robbin, ML, Greene, T, Allon, M, Dember, LM, Imrey, PB, Cheung, AK, Himmelfarb, J, Huber, TS, Kaufman, JS, Radeva, MK, et al
Journal of the American Society of Nephrology : JASN. 2018;(11):2735-2744
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Abstract
BACKGROUND The utility of early postoperative ultrasound measurements in predicting arteriovenous fistula (AVF) clinical maturation is uncertain. METHODS We investigated the relationships of ultrasound parameters with AVF clinical maturation in newly created AVF, measured at 1 day and 2 and 6 weeks, in 602 participants of a multicenter, observational cohort study. A backward elimination algorithm identified ultrasound measurements that independently predicted unassisted and overall AVF maturation. Candidate variables included AVF blood flow, diameter, and depth, upper arm arterial diameter, presence of stenosis, presence of accessory veins, seven case-mix factors (age, sex, black race, AVF location, diabetes, dialysis status, and body mass index), and clinical center. We evaluated the accuracy of the resulting models for clinical prediction. RESULTS At each ultrasound measurement time, AVF blood flow, diameter, and depth each predicted in a statistically significant manner both unassisted and overall clinical maturation. Moreover, neither the remaining ultrasound parameters nor case-mix factors were associated with clinical AVF maturation after accounting for blood flow, diameter, and depth, although maturation probabilities differed among clinical centers before and after accounting for these parameters. The crossvalidated area under the receiver operating characteristic curve for models constructed using these three ultrasound parameters was 0.69, 0.74, and 0.79 at 1 day and 2 and 6 weeks, respectively, for unassisted AVF clinical maturation and 0.69, 0.71, and 0.76, respectively, for overall AVF maturation. CONCLUSIONS AVF blood flow, diameter, and depth moderately predicted unassisted and overall AVF clinical maturation. The other factors considered did not further improve AVF maturation prediction.
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Blood pressure management in children on dialysis.
Paglialonga, F, Consolo, S, Edefonti, A, Montini, G
Pediatric nephrology (Berlin, Germany). 2018;(2):239-250
Abstract
Hypertension is a leading cause of cardiovascular complications in children on dialysis. Volume overload and activation of the renin-angiotensin-aldosterone system play a major role in the pathophysiology of hypertension. The first step in managing blood pressure (BP) is the careful assessment of ambulatory BP monitoring. Volume control is essential and should start with the accurate identification of dry weight, based on a comprehensive assessment, including bioimpedance analysis and intradialytic blood volume monitoring (BVM). Reduction of interdialytic weight gain (IDWG) is critical, as higher IDWG is associated with a worse left ventricular mass index and poorer BP control: it can be obtained by means of salt restriction, reduced fluid intake, and optimized sodium removal in dialysis. Optimization of peritoneal dialysis and intensified hemodialysis or hemodiafiltration have been shown to improve both fluid and sodium management, leading to better BP levels. Studies comparing different antihypertensive agents in children are lacking. The pharmacokinetic properties of each drug should be considered. At present, BP control remains suboptimal in many patients and efforts are needed to improve the long-term outcomes of children on dialysis.
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Current and potential therapeutic strategies for the management of vascular calcification in patients with chronic kidney disease including those on dialysis.
Ruderman, I, Holt, SG, Hewitson, TD, Smith, ER, Toussaint, ND
Seminars in dialysis. 2018;(5):487-499
Abstract
Patients with CKD have accelerated vascular stiffening contributing significantly to excess cardiovascular morbidity and mortality. Much of the arterial stiffening is thought to involve vascular calcification (VC), but the pathogenesis of this phenomenon is complex, resulting from a disruption of the balance between promoters and inhibitors of calcification in a uremic milieu, along with derangements in calcium and phosphate metabolic pathways. Management of traditional cardiovascular risk factors to reduce VC may be influential but has not been shown to significantly improve mortality. Control of mineral metabolism may potentially reduce the burden of VC, although using conventional approaches of restricting dietary phosphate, administering phosphate binders, and use of active vitamin D and calcimimetics, remains controversial because recommended biochemical targets are hard to achieve and clinical relevance hard to define. Increasing time on dialysis is perhaps another therapy with potential effectiveness in this area. Despite current treatments, cardiovascular morbidity and mortality remain high in this group. Novel therapies for addressing VC include magnesium and vitamin K supplementation, which are currently being investigated in large randomized control trials. Other therapeutic targets include crystallization inhibitors, ligand trap for activin receptors and BMP-7. This review summarizes current treatment strategies and therapeutic targets for the future management of VC in patients with CKD.
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Assessment and misassessment of potassium, phosphorus, and protein in the hemodialysis diet.
St-Jules, DE, Goldfarb, DS, Pompeii, ML, Liebman, SE, Sherman, RA
Seminars in dialysis. 2018;(5):479-486
Abstract
Diet is a key determinant of several common and serious disease complications in hemodialysis (HD) patients. The recommended balance and variety of foods in the HD diet is designed to limit high potassium and phosphorus foods while maintaining protein adequacy. In this report, we examine the potassium, phosphorus, and protein content of foods, and identify critical challenges, and potential pitfalls when translating nutrient prescriptions into dietary guidelines. Our findings highlight the importance of individualized counseling based on a comprehensive dietary assessment by trained diet professionals, namely renal dietitians, for managing diet-related complications in HD patients.
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Sertraline can reduce uremic pruritus in hemodialysis patient: A double blind randomized clinical trial from Southern Iran.
Pakfetrat, M, Malekmakan, L, Hashemi, N, Tadayon, T
Hemodialysis international. International Symposium on Home Hemodialysis. 2018;(1):103-109
Abstract
INTRODUCTION Uremic pruritus is an undesirable complication of end stage renal disease (ESRD). In spite of introduction of many treatments for this complication, it has no certain cure. The aim of this study was to assess sertraline effect on uremic pruritus. METHODS In the present clinical trial study, we randomly divided our patients into two groups; trial group that received sertraline and control group that consumed placebo. We measured the severity of pruritus by two scoring systems (visual analogue scale and DUO) at the beginning and during the study with a-2-week interval. Data were analyzed by SPSS 18.0 and a P value < 0.050 considered as significant. FINDINGS The mean age of our patients was 44.1 ± 16.1 years. Pruritus intensity significantly decreased in both groups (P < 0.001) and both scoring systems. Although the amount of decrease in trial group was significantly more than control group (P < 0.001). We found a direct relation between blood urea nitrogen and phosphorus and the degree of itching in VAS system (P < 0.009). There was a reverse significant relation between itching and calcium in both scoring systems (P < 0.012). Also pruritus intensity was directly correlated with C-reactive protein in both scoring systems (P < 0.05). DISCUSSION Depends on present study and previous ones, inflammation appears to play a significant role in uremic itching. Sertraline is an effective drug in reducing this complaint possibly due to its effect on reducing inflammatory cytokines. In addition there is no need to adjust sertraline dosage in patients with ESRD. Sertraline might be a treatment for patients with ESRD who do not respond to other routine drugs.
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Clinical-nutritional, inflammatory and oxidative stress predictors in hemodialysis mortality: a review.
Epifânio, APS, Balbino, KP, Ribeiro, SMR, Franceschini, SCC, Hermsdorff, HHM
Nutricion hospitalaria. 2018;(2):461-468
Abstract
The evaluation of clinical-nutrition status is essential to increase life quality and improve clinical outcomes of patients in hemodialysis (HD). In the absence of a gold standard, the goal of this integrative review was to present and discuss the latest scientific literature on the ability of clinical-nutritional indicators and inflammatory and oxidative stress markers to predict morbidity and mortality in HD. In this context, the lean and fat mass indexes have become good predictors of mortality in HD individuals, regardless of BMI. Subjective scoring systems have been more sensitive to malnutrition, and altogether anthropometric indicators may result in an early detection of mortality risk in this population. On the other hand, inflammation in HD, as assessed by C-reactive protein, is not only related to cardiometabolic alterations, but it is also one of the key-points in the development of malnutrition, exacerbated by the state of oxidative stress, which has been identified in this group by the increase of the serum levels of gamma-glutamyl transferase and malondialdehyde.
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Development and effect of a rational-emotive-behaviour-therapy-based self-management programme for early renal dialysis patients.
Kim, ES
Journal of clinical nursing. 2018;(21-22):4179-4191
Abstract
AIMS AND OBJECTIVES This study attempts to develop and determine the effect a rational-emotive-behaviour-therapy-based self-management programme can have on the self-efficacy, self-care, depression and dyssomnia of patients undergoing early renal dialysis. BACKGROUND When renal dialysis is initiated, changes in everyday life are inevitable, and patients can suffer from both psychological and physical symptoms. Hence, to obtain the best results from renal dialysis, active self-management is required. DESIGN Quasi-experimental and longitudinal. METHODS Forty-eight early-stage renal dialysis patients registered for and undergoing renal dialysis at a hospital located in S city participated in this study. These individuals were divided into an experimental and control group. The former group engaged in a self-management programme consisting of eight weekly sessions of 50 min in duration, while the latter received traditional nursing care. Data were collected from June 2012-May 2014 through the use of a preliminary survey, a postsurvey that was distributed after the eight sessions of the self-management programme had been completed, and a follow-up survey allocated 4 weeks after the postsurvey. Data collection was conducted using the Self-efficacy Scale, Self-care Practice Scale, Beck Depression Inventory, and Korean Sleep Scale, and a repeated-measures ANOVA was used to perform analysis. RESULTS The experimental group significantly differed from the control group in regard to self-efficacy (p = 0.006) and self-care (p = 0.031), but differences in terms of depression (p = 0.492) and dyssomnia (p = 0.141) were nonsignificant. In the experimental group, the depression decreased but then increased again, while the dyssomnia gradually decreased. CONCLUSIONS The provision of a rational-emotive-behaviour-therapy-based self-management programme that involves lectures, discussions, teach-backs, demonstrations and posters explaining diet choices improves the self-efficacy and self-care of patients receiving renal dialysis. RELEVANCE TO CLINICAL PRACTICE Rational-emotive-behaviour-therapy-based self-management programmes can be used in clinical nursing sites to improve the self-efficacy and self-care of early renal dialysis patients.
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Dietary protein and nutritional supplements in conventional hemodialysis.
Sabatino, A, Piotti, G, Cosola, C, Gandolfini, I, Kooman, JP, Fiaccadori, E
Seminars in dialysis. 2018;(6):583-591
Abstract
Protein energy wasting (PEW) is a condition commonly occurring among patients with ESRD on hemodialysis. PEW is characterized by depletion of protein and energy stores and is caused by multiple factors related to chronic kidney disease, acute and chronic comorbidities and by renal replacement therapy itself. Anorexia is central in the pathogenesis of PEW; it is frequently observed in these patients whose protein and energy intakes are typically lower than guidelines recommendations. If untreated, PEW invariably leads to major complications, and may activate a vicious circle with further worsening of nutritional status. Dietary counseling and nutritional status monitoring play a key role in the prevention and treatment of PEW, since they allow an early identification of high risk patients, as well as the assessment of the response to nutritional intervention. Different nutritional approaches can be implemented following thorough nutritional counseling. These are chosen on the basis of patients' spontaneous dietary intake, severity of PEW and acute comorbidities. Initially, regular encounters with the dietitian allow patients to clarify doubts and strengthen basic concepts on nutrition to improve dietary intake and prevent PEW. When PEW is present or the patient is at high risk, the clinician may opt for the administration of oral intradialytic or daily supplements, aiming at increasing energy and protein intake, while in selected cases intradialytic parenteral nutrition may be used. This review addresses the main issues of nutritional status in ESRD patients on hemodialysis-its evaluation and monitoring, as well as at describing the available nutritional interventions.
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Mineral and bone disorders in conventional hemodialysis: Challenges and solutions.
Hamano, T
Seminars in dialysis. 2018;(6):592-598
Abstract
Despite the advent of cinacalcet and noncalcium-containing phosphate binders, controlling the progression of vascular calcification (VC) is still challenging. Recent reports demonstrate that carbamylation driven by high urea concentration aggravates VC, suggesting the importance of adequate dialysis in retarding its progression. Theoretically, other promising measures include the use of iron-based phosphate binders, vitamin K, and magnesium supplements, which should be investigated in future randomized controlled trials (RCTs), ideally with hard outcomes. While incidence of hip fracture in patients on dialysis is decreasing in the United States and Japan (possibly owing to better control of PTH levels by cinacalcet) it remains much higher than that in the general population. Many drugs used in the treatment of osteoporosis, including bisphosphonate, raloxifene, denosumab, and teriparatide can, under specific conditions, increase bone mineral density (BMD), which is associated with a lower fracture rate. However, the efficacy of these drugs in reducing the fracture rate remains to be proven in hemodialysis (HD) patients, given their adverse effects such as severe hypocalcemia and resultant worsening of secondary hyperparathyroidism. Some clinical studies have shown that cinacalcet, lanthanum carbonate, and sevelamer reduce mortality in elderly patients on HD, suggesting the benefits of reducing PTH and serum phosphate levels. However, the target ranges of PTH and phosphate levels are based solely on observational studies. This is also the case when treating low PTH levels by decreasing vitamin D or calcium load. RCTs with hard clinical endpoints comparing different targets are necessary in the future.