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ABSTRACT Introduction: Brazil has the largest public and universal healthcare system in the world, but little is known about the outcomes of patients on hemodialysis (HD) in the country according to the source of funding for the treatment. Objective: To compare the profile and survival of patients under HD treatment funded by the Public Healthcare System (SUS) to those with private insurance. Methods: Retrospective analysis of adults undergoing HD between 2012 and 2017 in 21 dialysis centers in Brazil that provided both by the SUS and private health insurance. Participants, regardless of the paying source, received similar dialysis treatment. Data were censored after 60 months of follow-up or at the end of 2019. Results: 4,945 patients were included, 59.7% of which were financed by the SUS. Patients financed by SUS, compared to those with private insurance, were younger (58 vs. 60 years; p < 0.0001) and with a lower prevalence of diabetes (35.8% vs. 40.9%; p < 0.0001). The 60-month survival rates in these groups were 51.1% and 52.1%, respectively (p = 0.85). In the analysis of the subdistribution proportional hazard ratio by the Fine-Gray model, including adjustment for concurrent outcomes, a significant increase in the risk ratio for death was found (1.22 [95% confidence interval 1.04 to 1.43]) in patients with treatment funded by the SUS. Conclusions: Patients on HD with treatment funded by the SUS have a higher adjusted risk of death when compared to those with private insurance, despite similar dialysis treatment. Factors not directly related to dialysis therapy could explain this difference.

Resumo Introdução: O Brasil possui o maior sistema público e universal de saúde do mundo, mas pouco se sabe sobre os desfechos dos pacientes em hemodiálise (HD) no país de acordo com a fonte de financiamento do tratamento. Objetivo: Comparar o perfil e a sobrevida dos pacientes que têm o tratamento de HD custeado pelo Sistema Único de Saúde (SUS) com aqueles com convênio privado. Métodos: Análise retrospectiva dos adultos incidentes em HD entre 2012 e 2017 em 21 centros de diálise no Brasil que atendiam tanto pelo SUS quanto por convênios privados. Os participantes, independentemente da fonte pagadora, receberam tratamento dialítico semelhante. Os dados foram censurados com 60 meses de acompanhamento ou ao final de 2019. Resultados: Foram incluídos 4945 pacientes, sendo 59,7% financiados pelo SUS. Os pacientes financiados pelo SUS, em comparação aos que tinham convênio privado, eram mais jovens (58 vs 60 anos; p < 0,0001) e com menor prevalência de diabetes (35,8% vs 40,9%; p < 0,0001). As taxas de sobrevida, em 60 meses nesses grupos foram de 51,1% e 52,1%, respectivamente (p = 0,85). Na análise da razão de risco proporcional de subdistribuição pelo modelo de Fine-Gray, incluindo ajuste para desfechos concorrentes, foi encontrado um aumento significativo na razão de risco para morte (1,22 [intervalo de confiança de 95% 1,04 a 1,43]) nos pacientes com tratamento custeado pelo SUS. Conclusões: Pacientes em HD com tratamento custeado pelo SUS têm um risco ajustado de morte mais elevado do que aqueles com convênio privado, apesar do tratamento dialítico semelhante. Fatores não relacionados diretamente à terapia dialítica poderiam justificar esta diferença.

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OBJECTIVES: Chronic kidney disease (CKD) patients on hemodialysis may have a modified appetite due to several factors including a lack of uremic toxins elimination. The use of medium cutoff (MCO) dialysis membranes has been suggested as an alternative to improve the removal of toxins, especially those of medium and high molecular weight. This study aimed to compare the effect of hemodialysis using MCO and high-flux membranes on the appetite and leptin levels of CKD patients. DESIGN AND METHODS: This is a predefined exploratory analysis of a randomized, open study, with a crossover design of 28 weeks of follow-up, which compared the effects of MCO and high-flux membranes in 32 CKD patients on hemodialysis. Appetite assessments were performed using the Appetite and Food Satisfaction Questionnaire. RESULTS: The MCO group had an appetite score of 3.00 (1.00-5.50) and 3.00 (1.00-5.00) at the beginning and at the end of the treatment period, respectively, while the high-flux group had 1.00 (0.25-6.00) and 2.00 (0.75-3.25). There were no effects of treatment (P = .573), time (P = .376), and interaction (P = .770) between the MCO and high-flux groups. Leptin levels, at the beginning and at the end of the treatment period, were 2,342.30 (1,156.50-4,091.50) and 2,571.50 (1,619.40-4,036.47) pg/mL in the MCO group, respectively, and 2,183.15 (1,550.67-3,656.50) and 2,685.65 (1,458.20-3,981.08) pg/mL in the high-flux group. There was a time effect (P = .014), showing an increase in leptin levels in both groups, while treatment (P = .771) or interaction (P = .218) effects were not observed. CONCLUSIONS: There is no difference between the effects of MCO or high-flux membranes on leptin levels or appetite of CKD patients on hemodialysis.

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INTRODUCTION: Brazil has the largest public and universal healthcare system in the world, but little is known about the outcomes of patients on hemodialysis (HD) in the country according to the source of funding for the treatment. OBJECTIVE: To compare the profile and survival of patients under HD treatment funded by the Public Healthcare System (SUS) to those with private insurance. METHODS: Retrospective analysis of adults undergoing HD between 2012 and 2017 in 21 dialysis centers in Brazil that provided both by the SUS and private health insurance. Participants, regardless of the paying source, received similar dialysis treatment. Data were censored after 60 months of follow-up or at the end of 2019. RESULTS: 4,945 patients were included, 59.7% of which were financed by the SUS. Patients financed by SUS, compared to those with private insurance, were younger (58 vs. 60 years; p < 0.0001) and with a lower prevalence of diabetes (35.8% vs. 40.9%; p < 0.0001). The 60-month survival rates in these groups were 51.1% and 52.1%, respectively (p = 0.85). In the analysis of the subdistribution proportional hazard ratio by the Fine-Gray model, including adjustment for concurrent outcomes, a significant increase in the risk ratio for death was found (1.22 [95% confidence interval 1.04 to 1.43]) in patients with treatment funded by the SUS. CONCLUSIONS: Patients on HD with treatment funded by the SUS have a higher adjusted risk of death when compared to those with private insurance, despite similar dialysis treatment. Factors not directly related to dialysis therapy could explain this difference.

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Left ventricular hypertrophy is a risk factor for cardiovascular mortality in patients on peritoneal dialysis (PD). Because icodextrin has a greater ultrafiltration power compared with glucose-based solutions for long dwell, it could improve left ventricular mass by reducing fluid overload. This was a randomized clinical trial that included patients on PD recruited from 2 teaching hospitals, in Sao Paulo-Brazil. Patients were allocated to the control glucose group (GLU) or the intervention icodextrin (ICO) group. Clinical and cardiac magnetic resonance image (MRI) parameters were evaluated at baseline and 6 months after randomization. The primary outcome was the change in left ventricular mass adjusted by surface area (ΔLVMI), measured by cardiac MRI. A total of 22 patients completed the study (GLU, N = 12 and ICO, N = 10). Baseline characteristics such as age, sex, underlying disease, and time on dialysis were similar in both groups. At baseline, 17 patients (77.3%) presented with left ventricular hypertrophy with no difference between groups (p = 0.748). According to the total body water (TBW)/extracellular water (ECW) ratio, 36.8% and 80% of patients from GLU and ICO groups, respectively, were considered hypervolemic (p = 0.044). During follow-up, ΔLVMI was 3.9 g/m (- 10.7, 2.2) in GLU and 5.2 (- 26.8, 16.8) in ICO group (p = 0.651). ΔLVMI correlated with change in brain natriuretic peptide (r = 0.566, p = 0.044), which remained significant in a multiple regression analysis. The use of the icodextrin-based solution in prevalent patients on PD compared with a glucose-based solution was not able to improve LMV. A larger randomized trial with a longer follow-up period may be needed to show changes in LVM in this patient population.Trial registration: this study has been registered at ReBEC (Registro Brasileiro de Ensaios Clinicos) under the identification #RBR-2mzhmj2, available at: https://ensaiosclinicos.gov.br/pesquisador .

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BACKGROUND: KDIGO guidelines suggest the use of dual-energy X-ray absorptiometry (DXA) to assess bone mineral density (BMD) in patients with CKD 3a-5D. Previous studies have demonstrated an association between trabecular bone mass loss and coronary artery calcification (CAC) progression. This study aimed to prospectively investigate the relationship between BMD changes, quantified by DXA, and CAC progression in the non-dialyzed CKD population. METHODS: In this post hoc study, BMD by DXA was measured at the lumbar spine and total hip at baseline and 12-months. Patients were categorized according to BMD changes into 3 different groups: LOSS, UNCHANGED and GAIN. CAC quantification was obtained by multislice computed tomography at baseline and 12-months. RESULTS: 87 patients (55.6 ± 10.7 years, 62% males, 30% diabetic, eGFR = 39.2 ± 18.1 mL/min/1.73m2) were enrolled. CAC was found in 41 (47%) of the patients at baseline and CAC progression in 25 (64%) of them. Considering the lumbar spine and total hip BMD changes together, 24%, 48%, and 25% of the patients were in the LOSS, UNCHANGED and GAIN groups, respectively. Compared to the UNCHANGED or LOSS groups, the GAIN group had an increase in calcium score (p = 0.04) and a higher proportion of patients with CAC progression (p = 0.01). In the logistic regression analysis, CAC progression was 4.5 times more likely to be in the GAIN group. CONCLUSIONS: The association between the increase in BMD values and the progression of vascular calcification was the result of two concomitant processes overlapping, leading to a misinterpretation of DXA results. Thus, the use of DXA for the evaluation of bone mass, especially at the lumbar spine, must be applied with restraint and its results very carefully interpreted in CKD patients.

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Bone biopsy is still the gold standard tool to evaluate either trabecular or cortical bone, though the quantitative computed tomography of the vertebrae (QCT), a non-invasive technique, could be useful to evaluate bone structure in patients with chronic kidney disease (CKD). Cortical bone microstructure derangements have been associated with poor outcomes in the general population. An association between trabecular bone density, assessed by QCT, and bone volume and microarchitecture by histomorphometry, has been previously documented. This relationship has not yet been fully evaluated in cortical bone in the CKD scenario. The aim of this study was to evaluate the relationship among vertebrae density measured by QCT, structural histomorphometric parameters of cortical bone and biochemical and hormonal data in 50 CKD stage 2-5ND patients. This was a post hoc analysis of a cross-sectional study where cortical porosity and cortical thickness were analyzed in undecalcified bone samples from the iliac crest. The cortical bone density was obtained by QCT from the thoracic vertebrae. The patients were 52 ± 10 years, 68% men, 30% diabetes and the estimated glomerular filtration rate 34 ± 16 mL/min/1.73 m2. Cortical porosity was 4.6% (3.6; 6.6) and cortical thickness was 578.4 ± 151.8 µm, while cortical bone density was 149.2 ± 58.3 HU. Cortical density correlated with cortical thickness (p = 0.001) but not with cortical porosity (p = 0.30). Higher porosity was associated with older age (p = 0.02), higher levels of PTH (p = 0.04) and lower renal function (p = 0.03), while smaller thickness was associated with higher levels of PTH (p = 0.02). Lower density was associated with older age (p = 0.02) and higher levels of PTH (p = 0.01). In conclusion, cortical bone density measured by QCT was able to mirror the cortical thickness of bone biopsy in pre-dialysis CKD patients. In addition, PTH action on cortical bone can be already seen in this population.

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BACKGROUND: Although Brazil has one of the largest populations on haemodialysis (HD) in the world, data regarding patients' characteristics and the variables associated with risk of death are scanty. METHODS: This is a retrospective analysis of all adult patients who initiated on maintenance HD at 23 dialysis centres in Brazil between 2012 and 2017. Patients were censored after 60 months of follow-up or at the end of 2019. RESULTS: A total of 5,081 patients were included in the analysis. The median age was 59 years, 59.4% were men, 37.5% had diabetes as the cause of kidney failure. Almost 70% had a central venous catheter (CVC) as the initial vascular access, about 60% started dialysis in the hospital, and fluid overload (FO) by bioimpedance assessment was seen in 45% of patients. The 60-month survival rate was 51.4%. In the Cox regression analysis, being older (P<0.0001), starting dialysis in the hospital (P=0.016), having diabetes as the cause of kidney failure (P=0.001), high alkaline phosphatase (P=0.005), CVC as first vascular access (P=0.023), and FO (P<0.0001) were associated with higher death risk, whereas higher body mass index (P=0.015), haemoglobin (P=0.004), transferrin saturation (P=0.002), and serum albumin (P<0.0001) were associated with better survival. The same variables, except initial CVC use (P=0.14), were associated with death risk in an analysis of subdistribution proportional hazards ratio including the competing outcomes. CONCLUSIONS: The present study gives an overview of a large HD population in a developing country and identifies the main predictors of mortality, including some potentially modifiable ones, such as unplanned initiation of dialysis in the hospital and fluid overload.

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BACKGROUND: Microbiota-derived uremic toxins have been associated with inflammation that could corroborate with endothelial dysfunction (ED) and increase cardiovascular risk in patients with chronic kidney disease (CKD). This trial aimed to evaluate the effect of the prebiotic fructooligosaccharide (FOS) on endothelial function and arterial stiffness in nondialysis CKD patients. METHODS: In a double-blind controlled trial, 46 nondiabetic CKD patients were randomized to receive 12 g/day of FOS or placebo (maltodextrin) for 3 months. Total p-cresyl sulfate (PCS) and indoxyl sulfate by high-performance liquid chromatography, urinary trimethylamine N-oxide by mass spectrometry, C-reactive protein, interleukin-6 (IL-6), serum nitric oxide and stroma-derived factor-1 alfa were measured at baseline and at the end of follow-up; endothelial function was assessed through flow-mediated dilatation (FMD) and arterial stiffness by pulse wave velocity (PWV). RESULTS: The mean (± standard deviation) age of the study participants was 57.6 ± 14.4 years, with an estimated glomerular filtration rate of 21.3 ± 7.3 mL/min/1.73 m2. During the follow-up, regarding the inflammatory markers and uremic toxins, there was a significant decrease in IL-6 levels (3.4 ± 2.1 pg/mL versus 2.6 ± 1.4 pg/mL; P = 0.04) and a trend toward PCS reduction (55.4 ± 38.1 mg/L versus 43.1 ± 32.4 mg/L, P = 0.07) only in the prebiotic group. Comparing both groups, there was no difference in FMD and PWV. In an exploratory analysis, including a less severe ED group of patients (FMD ≥2.2% at baseline), FMD remained stable in the prebiotic group, while it decreased in the placebo group (group effect P = 0.135; time effect P = 0.012; interaction P = 0.002). CONCLUSIONS: The prebiotic FOS lowered circulating levels of IL-6 in CKD patients and preserved endothelial function only in those with less damaged endothelium. No effect of FOS in arterial stiffness was observed.

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BACKGROUND AND OBJECTIVES: High-volume online hemodiafiltration (OL-HDF) associates with improved outcomes compared to hemodialysis (HD), provided adequate dosing is achieved as estimated from convective volume (CV). Achievement of high CV and its impact on biochemical indicators following a standardized protocol converting HD patients to OL-HDF has not been systematically reported. We assessed the success of implementation of OL-HDF in clinics naïve to the modality. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: We analyzed the results of the implementation of postdilution OL-HDF in patients randomized to the HDF arm of a clinical trial (impact of hemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFit) trial [ClinicalTrials.gov:NCT02787161]). The day before randomization of the first patient to OL-HDF at each clinic staff started a 3-day in-person training module on operation of Fresenius 5008 CorDiax machine in HDF mode. Patients were converted from high-flux HD to OL-HDF under oversight of trainers. OL-HDF was performed over a 6-months follow-up with a CV target of 22 L/treatment. We characterized median achieved CV >22 L/treatment record and analyzed the impact of HDF on biochemical variables. RESULTS: Ninety-seven patients (mean age 53 ± 16 years, 29% with diabetes, and 11% had a catheter) from 13 clinics randomized to the OL-HDF arm of the trial were converted from HD to HDF. Median CV > 22 L/treatment was achieved in 99% (94/95) of OL-HDF patients throughout follow-up. Monthly mean CV ranged from 27.1 L to 27.5 L. OL-HDF provided an increased single pool Kt/V at 3-months (0.2 [95% CI: 0.1-0.3]) and 6-months (0.2 [95% CI: 0.1-0.4]) compared to baseline, and reduced phosphate at 3-months (-0.4 mg/dL [95% CI: -0.8 to -0.12]) of follow-up. CONCLUSIONS: High-volume online hemodiafiltration was successfully implemented with 99% of patients achieving protocol defined CV target. Monthly mean CV was consistently >22 L/treatment during follow-up. Kt/V increased, and phosphate decreased with OL-HDF. Findings resulting from a short training period in several dialysis facilities appear to suggest HDF is an easily implementable technique.

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BACKGROUND: Dialysis patients are typically inactive and their physical activity (PA) decreases over time. Uremic toxicity has been suggested as a potential causal factor of low PA in dialysis patients. Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD). METHODS: HDFIT was a randomized controlled trial at 13 clinics in Brazil that aimed to investigate the effects of HDF on measured PA (step counts) as a primary outcome. Stable HD patients (vintage 3-24 months) were randomized to receive HDF or high-flux HD. Treatment effect of HDF on the primary outcome from baseline to 3 and 6 months was estimated using a linear mixed-effects model. RESULTS: We randomized 195 patients (HDF 97; HD 98) between August 2016 and October 2017. Despite the achievement of a high convective volume in the majority of sessions and a positive impact on solute removal, the treatment effect HDF on the primary outcome was +538 [95% confidence interval (CI) -330 to 1407] steps/24 h after dialysis compared with HD, and was not statistically significant. Despite a lack of statistical significance, the observed size of the treatment effect was modest and driven by steps taken between 1.5 and 24.0 h after dialysis, in particular between 20 and 24 h (+197 steps; 95% CI -95 to 488). CONCLUSIONS: HDF did not have a statistically significant treatment effect on PA 24 h following dialysis, albeit effect sizes may be clinically meaningful and deserve further investigation.

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