Characteristics and predictors of mortality on haemodialysis in Brazil: a cohort of 5,081 incident patients.

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.

Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial.

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.

Effect of Hemodiafiltration on Self-Reported Sleep Duration: Results from a Randomized Controlled Trial.

INTRODUCTION: Dialysis patients suffer from poor sleep duration and quality. We examined the self-reported sleep duration in patients randomized to either high-volume hemodiafiltration (HDF) or high flux hemodialysis (HD). METHODS: Patients from 13 Brazilian dialysis clinics were enrolled in the HDFIT randomized controlled trial (RCT) investigating the impact of HDF on physical activity and self-reported outcomes. Self-reported sleep duration was taken from patient diaries recording sleep start and end time over a week during baseline, months 3 and 6, respectively. Sleep duration was analyzed by shift and nights relative to dialysis. RESULTS: The HDFIT study enrolled 197 patients; sleep data were available in 173 patients (87 HD; 86 HDF). Patients' age was 53 ± 15 years, 57% were white, 72% were male, 34% had diabetes, Kt/V was 1.54 ± 0.40, and albumin 3.97 ± 0.36 g/dL. Most patients reported sleeping 510-530 min/night. At 3 months, HDF patients slept 513 ± 71 min/night, HD patients 518 ± 76 min/night. At 6 months, HDF patients slept 532 ± 74 min/night, HD patients 519 ± 80 min/night. At baseline, 1st shift patients slept 406 ± 86 min the night before HD, 534 ± 64 min the night after HD, and 496 ± 99 min the night between 2 non-HD days. Compared to patients in the 2nd and 3rd shifts, patients dialyzed in the 1st shift slept less in the night before dialysis. Similar patterns were seen after 3 and 6 months. CONCLUSION: In our RCT, the dialysis modality (HDF vs. HD) had no effect on self-reported sleep duration. In both groups, dialysis in the 1st shift adversely affected self reported sleep duration.

Patient perception of vitality and measured physical activity in patients receiving haemodialysis.

AIM: Fatigue in haemodialysis (HD) patients can be captured in quality of life questionnaires and by the dialysis recovery time (DRT) question. The associations between fatigue and measured physical activity has not been explored until the present. We tested our hypothesis that the patient perception of chronic and post dialysis fatigue would be associated with lower physical activity. METHODS: This study was a cross sectional evaluation of baseline data from HD patients recruited in the HDFIT trial. Vitality scores from the Kidney Disease Quality of Life (KDQOL-36) and the dialysis recovery time (DRT) question were used as indicators of chronic and post dialysis fatigue, respectively. Granular physical activity was measured by accelerometers as part of the study protocol. RESULTS: Among 176 patients, Vitality score was 63 ± 21 and the DRT was ≤30 minutes in 57% of patients. The mean number of steps was 5288 ± 3540 in 24 hours after HD and 953 ± 617 in the 2-hour post-HD period. The multivariable analysis confirmed Vitality scores were associated with physical activity in the 24-hour post-HD period. In contrast, DRT was not associated with physical activity captured by the accelerometer in the period immediately (2 hours) after the HD session. CONCLUSION: Chronic fatigue was negatively associated with step counts, while patient perception of post-dialysis fatigue was not associated with physical activity. These patterns indicate limitations in interpretation of DRT. Since physical activity is an important component of a healthy life, our results may partially explain the associations between fatigue and poor outcomes in HD patients.

Association between extracellular volume control and survival in patients on short daily haemodialysis.

BACKGROUND: Fluid overload (FO) assessed by bioimpedance spectroscopy (BIS) is associated with higher mortality risk in maintenance haemodialysis (HD). The aim was to assess if a better management of FO through short daily haemodialysis (SDHD) could improve survival. METHODS: Retrospective analysis of patients who were on HD 3 sessions/week for at least 3 months and shifted to in-centre SDHD (5 or 6 sessions/week, 2 to 3 h/session) between July 2012 and June 2016 at 23 dialysis units in Brazil. The 12-month risk of death was analysed according to the predialysis hydration status measured before and 6 months after initiation of SDHD. Predialysis hydration status was considered adequate when FO ≤15% of extracellular volume. RESULTS: A total of 297 patients on SDHD were included in the analysis. Their median age was 57 (IQR 45-67) years, 62% were males, 44% diabetics, 57% on 6 dialysis sessions/week, with a median session duration of 130 (IQR 120-150) minutes. BIS assessment at initiation of the SDHD regimen was performed in 220 patients and FO > 15% was found in 46.4%. Twelve-month survival rates for those with FO ≤15 and > 15% before initiating SDHD were 87.4 and 88.0%, respectively (P = 0.92). BIS analysis when completing 6 months on SDHD were available for 229 patients, 26.6% with FO > 15%. The survival rates for the next 12 months (from the 6th to the 18th month of follow-up) for those with FO ≤15 and > 15% were 91.0 and 72.0%, respectively (P = 0.0006). In a Cox regression model, after adjustment for demographic, clinical and laboratory variables, FO ≤ 15% persisted associated with a lower mortality risk (hazard ratio 0.34, 95%CI 0.13-0.87). CONCLUSIONS: Moving from conventional HD to SDHD was associated with better control of excessive extracellular volume. Patients who reached or maintained predialysis fluid overload ≤15% after initiating SDHD presented a lower risk of death.

Impact of hemodialysis and post-dialysis period on granular activity levels.

BACKGROUND: Physical activity (PA) is typically lower on hemodialysis (HD) days. Albeit intradialytic inactivity is expected, it is unknown whether recovery after HD contributes to low PA. We investigated the impact of HD and post-HD period on granular PA relative to HD timing. METHODS: We used baseline data from the HDFIT trial conducted from August 2016 to October 2017. Accelerometry measured PA over 1 week in patients who received thrice-weekly high-flux HD (vintage 3 to 24 months), were clinically stable, and had no ambulatory limitations. PA was assessed on HD days (0 to ≤24 h after start HD), first non-HD days (> 24 to ≤48 h after start HD) and second non-HD day (> 48 to ≤72 h after start HD). PA was recorded in blocks/slices: 4 h during HD, 0 to ≤2 h post-HD (30 min slices), and > 2 to ≤20 h post-HD (4.5 h slices). Blocks/slices of PA were captured at concurrent/parallel times on first/second non-HD days compared to HD days. RESULTS: Among 195 patients (mean age 53 ± 15 years, 71% male), step counts per 24-h were 3919 ± 2899 on HD days, 5308 ± 3131 on first non-HD days (p < 0.001), and 4926 ± 3413 on second non-HD days (p = 0.032). During concurrent/parallel times to HD on first and second non-HD days, patients took 1308 and 1128 more steps (both p < 0.001). Patients took 276 more steps and had highest rates of steps/hour 2-h post-HD versus same times on first non-HD days (all p < 0.05). Consistent findings were observed on second non-HD days. CONCLUSIONS: PA was higher within 2-h of HD versus same times on non-HD days. Lower PA on HD days was attributable to intradialytic inactivity. The established PA profiles are of importance to the design and development of exercise programs that aim to increase activity during and between HD treatments. TRIAL REGISTRATION: HDFIT was prospectively registered 20 April 2016 on ClinicalTrials.gov (NCT02787161).

Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.

BACKGROUND: End stage renal disease (ESRD) patients require a renal replacement therapy (RRT) to filter accumulated toxins and remove excess water, which are associated with impaired physical function. Hemodialysis (HD) removes middle-molecular weight (MMW) toxins less efficiently compared to hemodiafiltration (HDF); we hypothesized HDF may improve physical function. We detailed the design and methodology of the HDFIT protocol that is testing whether changing from HD to HDF effects physical activity levels and various outcomes. METHODS: HDFIT is a prospective, multi-center, unblinded, randomized control trial (RCT) investigating the impact of dialysis modality (HDF verses HD) on objectively measured physical activity levels, self-reported quality of life, and clinical/non-clinical outcomes. Clinically stable patients with HD vintage of 3 to 24 months without any severe limitation ambulation were recruited from sites throughout southern Brazil. Eligible patients were randomized in a 1:1 ratio to either: 1) be treated with high volume online HDF for 6 months, or 2) continue being treated with high-flux HD. This study includes run-in and randomization visits (baseline), 3- and 6-month study visits during the interventional period, and a 12-month observational follow up. The primary outcome is the difference in the change in steps per 24 h on dialysis days from baseline to the 6-month follow up in patients treated with HDF versus HD. Physical activity is being measured over one week at study visits with the ActiGraph ( www.actigraphcorp.com ). For assessment of peridialytic differences during the dialysis recovery period, we will analyze granular physical activity levels based on the initiation time of HD on dialysis days, or concurrent times on non-dialysis days and the long interdialytic day. DISCUSSION: In this manuscript, we provide detailed information about the HDFIT study design and methodology. This trial will provide novel insights into peridialytic profiles of physical activity and various self-reported, clinical and laboratory outcomes in ESRD patients treated by high volume online HDF versus high-flux HD. Ultimately, this investigation will elucidate whether HDF is associated with patients having better vitality and quality of life, and less negative outcomes as compared to HD. TRIAL REGISTRATION: Registered on ClinicalTrials.gov on 20 April 2016 ( NCT02787161 ).

High volume online hemodiafiltration: a global perspective and the Brazilian experience.

Online hemodiafiltration (HDF) is a rapidly growing dialysis modality worldwide. In Brazil, the number of patients with private health insurance undergoing HDF has exceeded the number of patients on peritoneal dialysis. The achievement of a high convection volume was associated with better clinical imprand patient - reported outcomes confirming the benefits of HDF. The HDFit trial provided relevant practical information on the implementation of online HDF in dialysis centers in Brazil. This article aims to disseminate technical information to improve the quality and safety of this new dialysis modality.

PTH may predict early mortality in incident patients on hemodialysis: results from a large cohort.

PURPOSE: Parathyroid hormone (PTH) is merit as a risk factor for mortality in patients with chronic kidney disease in prevalent hemodialysis patients in a U shape. Most studies, however, do not focus on incident patients and those who died within the first 90 days of therapy. We evaluated PTH as a risk factor for mortality in a large cohort population in Brazil. METHODS: This is an observational cohort study that included 4317 adult patients who initiated hemodialysis between July 1st, 2012 and June 30, 2017. The main outcome was all-cause mortality. Fine-gray sub-distribution hazard models were used to evaluate survival in the presence of a competing event (kidney transplant). RESULTS: Median PTH levels of 252 (118, 479) pg/mL. There were 331 deaths during the first 90 days of therapy (6.7%), 430 in a 1-year follow-up (10.7%) and 1282 (32%) during the 5-year study period. Deaths according to PTH < 150, 150-600 and > 600 pg/mL corresponded to 38.1%, 33.0% and 28.5%, respectively (p < 0.001). In an adjusted model, patients who started dialysis with PTH < 150 pg/mL had a higher mortality risk within the first 90 days, but not in 1 year and 5 years after starting dialysis. Analyses in a subset of patients with a repeated PTH in 1 year (N = 1954) showed that although persistent PTH low levels (< 150 pg/mL) at 1 year were significantly associated with all-cause mortality, this result was not sustained after multiple adjustments. CONCLUSION: PTH < 150 pg/mL confers a high mortality risk in the first 90 days of dialysis. If this result reflects poor nutritional conditions, it deserves further investigations.

Survival in hemodialysis in Brazil according to the source of payment for the treatment: Public Healthcare System (SUS) versus private insurance.

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.

High-volume hemodiafiltration decreases the pre-dialysis concentrations of indoxyl sulfate and p-cresyl sulfate compared to hemodialysis: a post-hoc analysis from the HDFit randomized controlled trial.

BACKGROUND: Although high-volume online hemodiafiltration has been associated with higher clearance and lower pre-dialysis concentration of middle molecular weight toxins compared to hemodialysis, its effect on protein-bound uremic toxins has shown inconclusive results. In this study, we investigated whether hemodiafiltration impacts pre-dialysis plasma levels of the toxins indoxyl sulfate, p-cresyl sulfate, and indole-3-acetic acid compared to high-flux hemodialysis. METHODS: This is a post-hoc analysis of the multicenter, randomized controlled trial HDFit (ClinicalTrials.gov: NCT02787161). Uremic toxins were determined by high performance liquid chromatography at baseline, 3, and 6 months. Mean differences in monthly changes of pre-dialysis uremic toxin concentrations between hemodiafiltration and high-flux hemodialysis were analyzed using linear mixed-effect models. RESULTS: One hundred ninety-three patients (mean age 53 years old, 71% males) were analyzed. There were no differences between groups regarding clinical and biochemical characteristics at baseline or duration of dialysis session and blood flows throughout the follow-up. Mean differences in rates of change (µM/month, [confidence interval CI]) in high-flux hemodialysis vs. hemodiafiltration were 2.4 [0.3 to 4.56], 3.94 [- 1.54 to 9.41] and 0.06 [- 0.6 to 0.5] for indoxyl sulfate, p-cresyl sulfate and indole-3-acetic acid, respectively. In the exploratory analysis, these differences in high-flux hemodialysis vs. hemodiafiltration subgroup with convective volume > 27.5 L were 2.86 [0.43 to 5.28], 7.43 [0.7 to 14.16] and - 0.19 [- 0.88 to 0.50]. CONCLUSION: These exploratory findings suggest that hemodiafiltration is more effective in reducing indoxyl sulfate as compared to standard high-flux hemodialysis, and also that this effect was extended to p-cresyl sulfate in patients achieving higher convective volumes.

Achieving high convective volume in hemodiafiltration: Lessons learned after successful implementation in the HDFit trial.

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.

High volume online hemodiafiltration: a global perspective and the Brazilian experience / Hemodiafiltração on-line de alto volume: uma perspectiva global e a experiência brasileira

ABSTRACT Online hemodiafiltration (HDF) is a rapidly growing dialysis modality worldwide. In Brazil, the number of patients with private health insurance undergoing HDF has exceeded the number of patients on peritoneal dialysis. The achievement of a high convection volume was associated with better clinical imprand patient - reported outcomes confirming the benefits of HDF. The HDFit trial provided relevant practical information on the implementation of online HDF in dialysis centers in Brazil. This article aims to disseminate technical information to improve the quality and safety of this new dialysis modality.

RESUMO A hemodiafiltração (HDF) on-line é uma modalidade dialítica em rápido crescimento no mundo. No Brasil, o número de pacientes com planos de saúde privados tratados por HDF já ultrapassa aquele de pacientes em diálise peritoneal. O alcance de um alto volume convectivo associado à redução de desfechos clínicos e do risco de morte confirmam os benefícios da HDF. Dados nacionais do estudo HDFit forneceram informações práticas relevantes sobre a implementação da HDF on-line em clínicas de diálise no Brasil. O objetivo desta publicação é a disseminação de informações técnicas que possam auxiliar na utilização, com qualidade e segurança, dessa nova modalidade dialítica.

Survival in hemodialysis in Brazil according to the source of payment for the treatment: Public Healthcare System (SUS) versus private insurance / Sobrevida na hemodiálise no Brasil de acordo com a fonte pagadora do tratamento: Sistema Único de Saúde versus convênio privado

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.

One-Year Conservative Care Using Sodium Bicarbonate Supplementation Is Associated with a Decrease in Electronegative LDL in Chronic Kidney Disease Patients: A Pilot Study.

BACKGROUND: Chronic kidney disease (CKD) patients develop metabolic acidosis when approaching stages 3 and 4, a period in which accelerated atherogenesis may ensue. Studies in vitro show that low pH may increase low-density lipoprotein (LDL) oxidation, suggesting a role for chronic metabolic acidosis in atherosclerosis. The present study attempted to evaluate the effects of conservative care using oral sodium bicarbonate (NaHCO3) supplementation on the electronegative LDL [LDL(-)], a minimally oxidized LDL, plasma levels in CKD patients. METHODS: Thirty-one CKD patients were followed by a multidisciplinary team during 15 months of care in which 1.0 mmol/kg/day oral NaHCO3 supplementation was first given in the third month. Blood samples were collected 3 months before the initiation of oral NaHCO3 supplementation (T1), at the time of the beginning of supplementation (T2), and thereafter, each 4 months (T3, T4 and T5) until month 15 of care. Blood parameters and LDL(-) were measured from these collections. RESULTS: After 12 months of conservative care, creatinine clearance (MDRD) was kept stable, and serum bicarbonate (HCO3-) increased from 20.5 ± 2.9 to 22.6 ± 1.1 mM (p < 0.003). LDL(-) plasma levels declined from 4.5 ± 3.3 to 2.1 ± 0.9 U/L (p < 0.007) after reaching mean serum HCO3- levels of 22.6 ± 1.1 mM. CONCLUSIONS: Conservative care using oral NaHCO3 supplementation was able to stabilize renal function and decrease serum levels of LDL(-), a modified proatherogenic lipoprotein, only when mean serum HCO3- levels approached 22 mM. This study constitutes evidence that alkali therapy, in addition to its beneficial effect on renal disease progression, might serve as a preventive strategy to attenuate atherogenesis in CKD patients.

Early changes in serum albumin: impact on 2-year mortality in incident hemodialysis patients.

INTRODUCTION/OBJECTIVE: We evaluated the predictability of early changes in serum albumin (sAlb) on the two-year mortality of incident hemodialysis patients. METHODS: Observational, longitudinal retrospective study using the database of Fresenius Medical Care of Latin America. Adult patients starting dialysis from January/2000 to June/2004, from 25 centers were included. Changes in sAlb during the first 3 months on hemodialysis were used as the main predictor. The outcome was death from any cause. RESULTS: 1,679 incident patients were included. They were 52 ± 15 years old, 58.7% male and 21.5% diabetic, with a median sAlb of 38 g/L (bromocresol green). 923 patients had sAlb < 38 g/L (Low sAlb Group) and 756 ones had sAlb > 38.0 g/L (Adequate sAlb Group). The mortality was significantly higher in Low sAlb Group (17% vs. 11%, p < 0.001). Early changes in sAlb significantly affected two-year mortality. Factoring the Kaplan Meier curve of Low sAlb Group by the presence of an increase in sAlb uncovered of a statistically significant difference in mortality favoring the ones whose sAlb went up (19% vs. 15%, p = 0.043). Differently, patients from Adequate sAlb Group with a decrease in their sAlb had a statistically higher mortality rate (13% vs. 8%, p = 0.029). CONCLUSIONS: Early sAlb changes showed a significant predictive power on mortality at 2 years in incident hemodialysis patients. Those with low initial sAlb may have a better prognosis if their sAlb rises. In contrast, patients with satisfactory initial levels can have a worsening of their prognosis in the case of an early reduction in sAlb.

Assessment of a five-year survival on hemodialysis in Brazil: a cohort of 3,082 incident patients.

Brazil has the third largest contingent of patients on maintenance hemodialysis (HD) worldwide. However, little is known regarding survival rate and predictors of mortality risk in that population, which are the purposes of this study. A total of 3,082 patients incident on HD, from 2000 to 2004, at 25 dialysis facilities distributed among 7 out of 26 states of Brazil were followed-up until 2009. Patients were 52 ± 16 years-old, 57.8% men, and 20.4%, diabetics. The primary outcome was all causes of mortality. Data were censored at five years of follow-up. The global five-year survival rate was 58.2%. In the Cox proportional model, variables associated with risk of death were: age (hazard ratio - HR = 1.44 per decade, p < 0.0001), diabetes (HR = 1.51, p < 0.0001), serum albumin (HR = 0.76 per g/dL, p = 0.001), creatinine (HR = 0.92 per mg/dL, p < 0.0001), and phosphorus (HR = 1.06 per mg/dL, p = 0.04). The present results show that the mortality rate on HD in this Brazilian cohort was relatively low, but the population is younger and with a lower prevalence of diabetes than the ones reported for developed countries.

Early changes in serum albumin: impact on 2-year mortality in incident hemodialysis patients / Alterações precoces da albumina sérica: impacto sobre a mortalidade aos 2 anos em pacientes incidentes em hemodiálise

Abstract Introduction/objective: We evaluated the predictability of early changes in serum albumin (sAlb) on the two-year mortality of incident hemodialysis patients. Methods: Observational, longitudinal retrospective study using the database of Fresenius Medical Care of Latin America. Adult patients starting dialysis from January/2000 to June/2004, from 25 centers were included. Changes in sAlb during the first 3 months on hemodialysis were used as the main predictor. The outcome was death from any cause. Results: 1,679 incident patients were included. They were 52 ± 15 years old, 58.7% male and 21.5% diabetic, with a median sAlb of 38 g/L (bromocresol green). 923 patients had sAlb < 38 g/L (Low sAlb Group) and 756 ones had sAlb > 38.0 g/L (Adequate sAlb Group). The mortality was significantly higher in Low sAlb Group (17% vs. 11%, p < 0.001). Early changes in sAlb significantly affected two-year mortality. Factoring the Kaplan Meier curve of Low sAlb Group by the presence of an increase in sAlb uncovered of a statistically significant difference in mortality favoring the ones whose sAlb went up (19% vs. 15%, p = 0.043). Differently, patients from Adequate sAlb Group with a decrease in their sAlb had a statistically higher mortality rate (13% vs. 8%, p = 0.029). Conclusions: Early sAlb changes showed a significant predictive power on mortality at 2 years in incident hemodialysis patients. Those with low initial sAlb may have a better prognosis if their sAlb rises. In contrast, patients with satisfactory initial levels can have a worsening of their prognosis in the case of an early reduction in sAlb. .

Resumo Introdução/objetivo: Avaliou-se o impacto das alterações precoces na albumina sérica (sAlb) na mortalidade em 2 anos de hemodialisados incidentes. Métodos: Estudo longitudinal retrospectivo usando o banco de dados da Fresenius Medical Care da América Latina. Adultos iniciando diálise de janeiro de 2000 a junho de 2004, originados de 25 centros de diálise foram incluídos. Mudanças na sAlb durante os primeiros 3 meses em hemodiálise foram usadas como a variável de principal interesse. O desfecho foi morte por qualquer causa. Resultados: Um total de 1.679 pacientes incidentes foi incluído. Eles tinham 52 ± 15 anos, 58,7% eram do sexo masculino e 21,5%, diabéticos, com sAlb mediana de 38,0 g/L (bromocresol verde). Novecentos e vinte e três pacientes tiveram sAlb ≤ 38,0 g/L (Grupo sAlb baixa) e 756, sAlb > 38,0 g/L (Grupo sAlb adequada). A mortalidade foi significativamente maior no Grupo sAlb baixa (17% vs. 11%, p < 0,001). Alterações precoces na sAlb afetaram significativamente a mortalidade em dois anos. Fatoração da curva de Kaplan-Meier do Grupo sAlb baixa pela presença de um aumento na sAlb revelou uma diferença na mortalidade favorecendo aqueles cuja sAlb subiu (19% vs. 15%, p = 0,043). Em contraste, pacientes do Grupo sAlb adequada que mostraram diminuição na sAlb tiveram maior taxa de mortalidade (13% vs. 8%, p = 0,029). Conclusão: Alterações precoces na sAlb mostraram um poder previsor significativo sobre a mortalidade em 2 anos em hemodialisados incidentes. Casos com sAlb inicial baixa melhoraram seu prognóstico quando houve elevação na sAlb, enquanto que aqueles com níveis iniciais satisfatórios tiveram um agravamento de seu prognóstico quando houve redução na sAlb. .

Avaliação da sobrevida de cinco anos em hemodiálise no Brasil: uma coorte de 3.082 pacientes incidentes / Assessment of a five-year survival on hemodialysis in Brazil: a cohort of 3,082 incident patients

O Brasil tem o terceiro maior contingente de pacientes em hemodiálise (HD) no mundo. Todavia, pouco conhece-se sobre a taxa de sobrevida e os preditores do risco de mortalidade nessa população, que são os objetivos deste estudo. Um total de 3.082 pacientes incidentes em HD, de 2000 a 2004, em 25 unidades de diálise distribuídas por 7 dos 26 estados do Brasil, foi acompanhado até 2009. Os pacientes tinham entre 52 ± 16 anos de idade, 57,8 por cento eram homens e 20,4 por cento, diabéticos. O desfecho primário foi de mortalidade por todas as causas. Os dados foram censurados aos cinco anos de seguimento. A taxa global de sobrevida em cinco anos foi de 58,2 por cento. No modelo proporcional de Cox, as variáveis associadas ao risco de óbito foram: a idade (risco relativo - RR = 1,44 por década; p < 0,0001), diabetes (RR = 1,51; p < 0,0001), albumina sérica (RR = 0,76 por g/dL; p = 0,001), creatinina (RR = 0,92 por mg/dL; p < 0,0001) e fósforo (RR = 1,06 por mg/dL; p = 0,04). Os resultados mostram que a taxa de mortalidade em HD nesta coorte brasileira foi relativamente baixa, mas a população é mais jovem e com prevalência de diabetes mais baixa do que aquela descrita nos países desenvolvidos.

Brazil has the third largest contingent of patients on maintenance hemodialysis (HD) worldwide. However, little is known regarding survival rate and predictors of mortality risk in that population, which are the purposes of this study. A total of 3,082 patients incident on HD, from 2000 to 2004, at 25 dialysis facilities distributed among 7 out of 26 states of Brazil were followed-up until 2009. Patients were 52 ± 16 years-old, 57.8 percent men, and 20.4 percent, diabetics. The primary outcome was all causes of mortality. Data were censored at five years of follow-up. The global five-year survival rate was 58.2 percent. In the Cox proportional model, variables associated with risk of death were: age (hazard ratio - HR = 1.44 per decade, p < 0.0001), diabetes (HR = 1.51, p < 0.0001), serum albumin (HR = 0.76 per g/dL, p = 0.001), creatinine (HR = 0.92 per mg/dL, p < 0.0001), and phosphorus (HR = 1.06 per mg/dL, p = 0.04). The present results show that the mortality rate on HD in this Brazilian cohort was relatively low, but the population is younger and with a lower prevalence of diabetes than the ones reported for developed countries.