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Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial.
Fernández Lucas, M, Ruíz-Roso, G, Merino, JL, Sánchez, R, Bouarich, H, Herrero, JA, Muriel, A, Zamora, J, Collado, A
Trials. 2020;(1):206
Abstract
BACKGROUND Thrice-weekly haemodialysis is the usual dose when starting renal replacement therapy; however, this schedule is no longer appropriate since it does not consider residual renal function. Several reports have suggested the potential benefit of beginning haemodialysis less frequently and incrementally increasing the dose as the residual renal function decreases. However, all the data published so far are from observational studies. Thus, this clinical trial avoids any potential selection bias and will assess the possible benefits that have been observed in observational studies. METHODS/DESIGN This report describes the study protocol of a randomized prospective multi-centre open-label clinical trial to evaluate whether starting renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than the standard thrice-weekly regimen. We also explore other clinical parameters, such as concentrations of uremic toxins, dialysis doses, control of anaemia, removal of medium-weight uremic toxins, nutritional status, quality of life, hospital admissions and mortality. Only incident haemodialysis patients who can maintain a urea clearance rate KrU ≥ 2.5 mL/min/1.73 m2 are eligible. Patient recruitment began on 1 January 2017 and will last for 2 years or until the required sample size has been recruited to ensure the established statistical power has been reached. The minimum follow-up period will be 1 year. Anuric patients with acute renal failure and patients who return to haemodialysis after a kidney transplant failure are excluded. It has been calculated that 44 patients should be recruited into each group to achieve a power of 80% in a two-sided comparison of means with a usual significance level of 0.05. A time-to-event analysis will estimate the probability of kidney function survival in both groups using the Kaplan-Meier method. Survival curves will be compared with log-rank tests. This survival analysis will be complemented with a proportional hazard model to estimate the hazard ratio of kidney function survival adjusted for any confounding factors. Analyses will be carried out in accordance with the intention-to-treat principle. DISCUSSION The incremental initiation of dialysis may preserve residual renal function better than the conventional treatment, with similar or higher survival rates, as reported by observational studies. To our knowledge, this is the first clinical trial to evaluate whether initiating renal replacement therapy with twice-weekly haemodialysis sessions preserves residual renal function better than beginning with the standard thrice-weekly regimen. TRIAL REGISTRATION ClinicalTrials.gov, NCT03302546. Registered on 5 October 2017.
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Sodium, volume and pressure control in haemodialysis patients for improved cardiovascular outcomes.
Pinter, J, Chazot, C, Stuard, S, Moissl, U, Canaud, B
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2020;(Suppl 2):ii23-ii30
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Abstract
Chronic volume overload is pervasive in patients on chronic haemodialysis and substantially increases the risk of cardiovascular death. The rediscovery of the three-compartment model in sodium metabolism revolutionizes our understanding of sodium (patho-)physiology and is an effect modifier that still needs to be understood in the context of hypertension and end-stage kidney disease. Assessment of fluid overload in haemodialysis patients is central yet difficult to achieve, because traditional clinical signs of volume overload lack sensitivity and specificity. The highest all-cause mortality risk may be found in haemodialysis patients presenting with high fluid overload but low blood pressure before haemodialysis treatment. The second highest risk may be found in patients with both high blood pressure and fluid overload, while high blood pressure but normal fluid overload may only relate to moderate risk. Optimization of fluid overload in haemodialysis patients should be guided by combining the traditional clinical evaluation with objective measurements such as bioimpedance spectroscopy in assessing the risk of fluid overload. To overcome the tide of extracellular fluid, the concept of time-averaged fluid overload during the interdialytic period has been established and requires possible readjustment of a negative target post-dialysis weight. 23Na-magnetic resonance imaging studies will help to quantitate sodium accumulation and keep prescribed haemodialytic sodium mass balance on the radar. Cluster-randomization trials (e.g. on sodium removal) are underway to improve our therapeutic approach to cardioprotective haemodialysis management.
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One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.
Bushinsky, DA, Chertow, GM, Cheng, S, Deng, H, Kopyt, N, Martin, KJ, Rastogi, A, Ureña-Torres, P, Vervloet, M, Block, GA
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2020;(10):1769-1778
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BACKGROUND Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis. METHODS This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231. RESULTS Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P. CONCLUSIONS Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.
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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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The transition clinic in chronic kidney disease care.
Evans, M, Lopau, K
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2020;(Suppl 2):ii4-ii10
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People with advanced chronic kidney disease and evidence of progression have a high risk of renal replacement therapy. Specialized transition clinics could offer a better option for preparing these patients for dialysis, transplantation or conservative care. This review focuses on the different aspects of such transition clinics. We discuss which patients should be referred to these units and when referral should take place. Patient involvement in the decision-making process is important and requires unbiased patient education. There are many themes, both patient-centred and within the healthcare structure, that will influence the process of shared decision-making and the modality choice. Aspects of placing an access for haemodialysis and peritoneal dialysis are reviewed. Finally, we discuss the importance of pre-emptive transplantation and a planned dialysis start, all with a focus on multidisciplinary collaboration at the transition clinic.
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Using Bioimpedance Spectroscopy to Assess Volume Status in Dialysis Patients.
van der Sande, FM, van de Wal-Visscher, ER, Stuard, S, Moissl, U, Kooman, JP
Blood purification. 2020;(1-2):178-184
Abstract
The aim of the paper is to reflect on the current status of bioimpedance spectroscopy (BIS) in fluid management in dialysis patients. BIS identifies fluid overload (FO) as a virtual (overhydration) compartment, which is calculated from the difference between the measured extracellular volume and the predicted values based on a fixed hydration of lean and adipose tissue mass. FO is highly prevalent in both hemodialysis (HD) and peritoneal dialysis (PD) patients, while levels of FO are at a population level comparable between PD patients and HD patients when measured before the dialysis treatment. Even mild levels of FO are independently related to outcome in patients on HD, PD as well as in nondialysis patients with advanced chronic kidney disease. FO is not only related to left ventricular hypertrophy (LVH) but also forms part of a multidimensional spectrum with noncardiovascular risk factors such as malnutrition and inflammation. Even after multiple adjustments, FO remains an independent predictor of mortality. BIS-assisted adjustment of dry weight in HD patients has been shown to improve hypertension control and LVH and has resulted in a decline in intradialytic symptomatology. On the other hand, with increased fluid removal, target weight may not always be reached due to an increase in intradialytic symptomatology, and care should be applied in target weight adjustment in fluid overloaded patients with severe malnutrition and/or inflammation. Although a reduction in hospitalization rate was suggested, the effect of BIS-guided dry weight adjustment on mortality has not yet been shown, however, although available studies are underpowered. In PD patients, results have been more equivocal, which may be partly related to differences in treatment protocols or study populations. Future large-scale studies are needed to assess the full potential of BIS.
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The Effects of Nano-curcumin Supplementation on Serum Level of hs-CRP, Adhesion Molecules, and Lipid Profiles in Hemodialysis Patients, A Randomized Controlled Clinical Trial.
Vafadar Afshar, G, Rasmi, Y, Yaghmaei, P, Khadem-Ansari, MH, Makhdomii, K, Rasooli, J
Iranian journal of kidney diseases. 2020;(1):52-61
Abstract
INTRODUCTION Hemodialysis (HD) patients are considered as a high-risk population for cardiovascular disease, within which morbidity and mortality have been determined to be associated with dyslipidemia, pro-inflammatory cytokines, increased levels of C-reactive protein (CRP), and adhesion molecules (ICAM-1, VCAM-1). Different markers have been investigated to detect inflammation in hemodialysis patients, as well as the prognostic values of these markers. METHODS The present study aimed to investigate the effect of nano-curcumin (120 mg) over 12 weeks on hs-CRP levels, adhesion molecules (ICAM-1, VCAM-1), and serum lipid profiles on hemodialysis patients in a randomized controlled clinical trial. RESULTS The results revealed that the mean serum hs-CRP level in the nano-curcumin group exhibited a decrease by the end of the study, when compared to mean serum hs-CRP level in the placebo group. However, this between-group trend was not found to be statistically significant (P > .05). Nevertheless, a significant difference was determined between the values in the group receiving nano-curcumin, in comparison with the placebo group, at the end of the study (P < .001). Based on the attained results, mean serum levels of VCAM-1 in the nano-curcumin group were significantly reduced at the end of the study, compared with the placebo group (P < .001). Furthermore, the between-group changes comparison showed significant reductions in serum levels of ICAM- 1 in patients treated with nano-curcumin at the end of the study (P < .05). Additionally, though decreases in mean triglycerides, total cholesterol, LDL-C were noted, there were no statistically significant between-group differences (P > .05). Moreover, between-group changes comparison of HDL-C levels and fasting blood sugar did not show any significant changes. CONCLUSION The current study indicates that nano-curcumin may show beneficial effects in lowering inflammation and hs-CRP levels, as well as adhesion molecules (ICAM-1, VCAM-1), in hemodialysis patients. However, the evidence is still insufficient.
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Bioelectrical impedance analysis-derived phase angle as a determinant of protein-energy wasting and frailty in maintenance hemodialysis patients: retrospective cohort study.
Saitoh, M, Ogawa, M, Kondo, H, Suga, K, Takahashi, T, Itoh, H, Tabata, Y
BMC nephrology. 2020;(1):438
Abstract
BACKGROUND Phase angle (PA), measured by bioelectrical impedance analysis (BIA) has been studied as indicator of nutritional status or muscle function in hemodialysis (HD) patients. It remains unclear if the phase angle is associated protein-energy wasting (PEW) or frailty, which are common complication in hemodialysis patients. The aim of this study is to determine whether BIA-derived PA is a marker of PEW or frailty in HD patients. METHODS This retrospective observational study included 116 adult HD patients (35% female, 64 ± 12 years of age) in a single dialysis center. Patients were classified according to the PA quartiles into four groups; 1) first quartile: PA < 3.7°, 2) second quartile: PA 3.7-4.1°, 3) third quartile: PA 4.2-4.9°and 4) forth quartile: PA ≥ 5.0°. International Society of Renal Nutrition and Metabolism (ISRNM) criteria and Japanese version of Cardiovascular Health Study (J-CHS) criteria were used to identify PEW and frailty. RESULTS The lower PA group was associated with a greater risk of PEW (35% vs. 24% vs. 21% vs. 3%; p = 0.032), frailty (59% vs. 40% vs. 21% vs. 3%; p < 0.001). In multivariate logistic regression analysis, the first quartile group was at a significantly greater risk of both PEW and frailty compared with the fourth quartile group after adjusting for other confounding factors. CONCLUSIONS Lower PA was associated with a greater risk of PEW and frailty in HD patients.
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Can Helicobacter pylori Colonization Affect the Phosphate Binder Pill Burden in Dialysis Patients?
Korucu, B, Helvaci, O, Sadioglu, R, Ozbas, B, Yeter, H, Derici, U
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;(4):380-386
Abstract
Phosphate binder pill (PBP) burden is a significant problem in dialysis patients. Phosphate absorption through the paracellular pathway increases in relatively acidic pH. In this study, we evaluated the effect of factors contributing to duodenal pH-Helicobacter pylori (HP), proton pump inhibitors (PPIs), and NaHCO3 capsules-on PBP burden. We evaluated 255 dialysis patients with gastric biopsies and excluded patients with low Kt/V, gastrectomy, and parathyroidectomy. Patients were divided into groups and subgroups regarding HP existence, use of PPI, or NaHCO3 capsules. HP+ group had significantly higher PBP burden and PBP equivalent doses (P < 0.001; both). HP+ subgroup not using daily PPIs or NaHCO3 capsules had the highest PBP burden and PBP equivalent doses (P < 0.001; both). HP- subgroups had similar PBP and PBP equivalent doses (P = 0.446 and P = 0.382; respectively). HP colonization might affect the PBP burden in dialysis patients due to a decrease of duodenal pH.
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Psycho-social and educational interventions for enhancing adherence to dialysis in adults with end-stage renal disease: A meta-analysis.
Tao, WW, Tao, XM, Wang, Y, Bi, SH
Journal of clinical nursing. 2020;(15-16):2834-2848
Abstract
AIMS AND OBJECTIVES To examine the influence of psycho-social and educational interventions on improving adherence to dialysis for patients with end-stage renal disease. BACKGROUND Adherence to the complex regimen is poor, contributing to avoidable hospitalisation and morbidity. Psycho-social and educational interventions may be beneficial coping strategies. DESIGN Systematic literature review and meta-analysis were conducted. METHODS We conducted a systematic search of 8 databases from their inceptions to 16 January 2019 to identify relevant articles. Only randomised controlled trials (RCTs) were included in the analysis. The PRISMA checklist was used. RESULTS A total of forty RCTs were included to evaluate the effect. The aggregated results of the studies showed that psycho-social and educational interventions elevated adherence rate in both peritoneal dialysis (PD) and haemodialysis (HD) patients. For physiological and biochemical indicators, meta-analysis revealed that significant post-treatment effects were evident for interdialytic weight gain (IDWG), IDWG/dry weight, serum potassium, phosphate, creatinine and blood urea nitrogen (BUN), except for albumin. In particular, subgroup analysis indicated that only the interventions carried out individually exerted significant combined effect for lowering IDWG. As for subjective measures, meta-analysis also revealed small but significant combined effects. CONCLUSIONS The results of this meta-analysis suggest that psycho-social and educational interventions were associated with significant effects on adherence in patients receiving dialysis regimen. RELEVANCE TO CLINICAL PRACTICE The analysis suggests that psycho-social and educational interventions should be considered as effective strategies for enhancing adherence to dialysis in adults with end-stage renal disease. The potential utility of these interventions should focus on how best to promote individually implementation in clinical practice.