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Background Various prediction models have been developed to predict the risk of kidney failure in patients with CKD. However, guideline-recommended models have yet to be compared head to head, their validation in patients with advanced CKD is lacking, and most do not account for competing risks. Methods To externally validate 11 existing models of kidney failure, taking the competing risk of death into account, we included patients with advanced CKD from two large cohorts: the European Quality Study (EQUAL), an ongoing European prospective, multicenter cohort study of older patients with advanced CKD, and the Swedish Renal Registry (SRR), an ongoing registry of nephrology-referred patients with CKD in Sweden. The outcome of the models was kidney failure (defined as RRT-treated ESKD). We assessed model performance with discrimination and calibration. Results The study included 1580 patients from EQUAL and 13,489 patients from SRR. The average c statistic over the 11 validated models was 0.74 in EQUAL and 0.80 in SRR, compared with 0.89 in previous validations. Most models with longer prediction horizons overestimated the risk of kidney failure considerably. The 5-year Kidney Failure Risk Equation (KFRE) overpredicted risk by 10%-\18%. The four- and eight-variable 2-year KFRE and the 4-year Grams model showed excellent calibration and good discrimination in both cohorts. Conclusions Some existing models can accurately predict kidney failure in patients with advanced CKD. KFRE performed well for a shorter time frame (2 years), despite not accounting for competing events. Models predicting over a longer time frame (5 years) overestimated risk because of the competing risk of death. The Grams model, which accounts for the latter, is suitable for longer-term predictions (4 years).

COVID-19 is one of the most important problems for public health, according to the number of deaths associated to this pathology reported so far. However, from the epidemiological point of view, the dimension of the problem is still unknown, since the number of actual cases of SARS-CoV-2 infected people is underestimated, due to limited testing. This paper aims at estimating the actual Infection Fatality Ratio (number of deaths with respect to the number of infected people) and the actual current prevalence (number of infected people with respect to the entire population), both in a specific population and all over the world. With this aim, this paper proposes a method to estimate Infection Fatality Ratio of a still ongoing infection, based on a daily estimation, and on the relationship between this estimation and the number of tests performed per death. The method has been applied using data about COVID-19 from Italy. Results show a fatality ratio of about 0.9%, which is lower than previous findings. The number of actual infected people in Italy is also estimated, and results show that (i) infection started at the end of January 2020, (ii) a maximum number of about 100,000 new cases in one day was reached at the beginning of March 2020, (iii) the estimated cumulative number of infections at the beginning of October 2020 is about 4.2 million cases in Italy (more than 120 million worldwide, if a generalization is conjectured as reasonable). Therefore, the prevalence at the beginning of October 2020 is estimated at about 6.9% in Italy (1.6% worldwide, if a generalization is conjectured).

Background: ESRD (end-stage renal disease) patients have a high cardiovascular mortality risk. A morphofunctional approach of vascular calcifications and myocardial perfusion is needed for the management of ESRD patients. We used SEVR (sub-endocardial viability ratio) and Kauppila score from the dialysis population of the Independent study to create a new morpho-functional score to assess cardiovascular risk in this population (the Solofra score). Materials and Methods: 184 patients were followed-up for 36 months. A side lumbar X-ray was performed to assess vascular calcifications of lumbar aorta using the Kauppila score. Central aortic pressure and pulse velocity wave (PWV) were assessed at the carotid artery site. Myocardial perfusion was estimated with SEVR. Independent risk mortality factors were identified with univariate regression analysis (p

Background: Metabolic acidosis is a common complication of chronic kidney disease; current guidelines recommend treatment with alkali if bicarbonate levels are lower than 22 mMol/L. In fact, recent studies have shown that an early administration of alkali reduces progression of CKD. The aim of the study is to evaluate the effect of fruit and vegetables to reduce the acid load in CKD. Methods: We conducted a case-control study in 146 patients who received sodium bicarbonate. Of these, 54 patients assumed very low-protein diet (VLPD) and 92 were controls (ratio 1:2). We calculated every three months the potential renal acid load (PRAL) and the net endogenous acid production (NEAP), inversely correlated with serum bicarbonate levels and representing the non-volatile acid load derived from nutrition. Un-paired T-test and Chi-square test were used to assess differences between study groups at baseline and study completion. Two-tailed probability values ≤0.05 were considered statistically significant. Results: At baseline, there were no statistical differences between the two groups regarding systolic blood pressure (SBP), diastolic blood pressure (DBP), protein and phosphate intake, urinary sodium, potassium, phosphate and urea nitrogen, NEAP, and PRAL. VLPD patients showed at 6 and 12 months a significant reduction of SBP (p < 0.0001), DBP (p < 0.001), plasma urea (p < 0.0001) protein intake (p < 0.0001), calcemia (p < 0.0001), phosphatemia (p < 0.0001), phosphate intake (p < 0.0001), urinary sodium (p < 0.0001), urinary potassium (p < 0.002), and urinary phosphate (p < 0.0001). NEAP and PRAL were significantly reduced in VLPD during follow-up. Conclusion: VLPD reduces intake of acids; nutritional therapy of CKD, that has always taken into consideration a lower protein, salt, and phosphate intake, should be adopted to correct metabolic acidosis, an important target in the treatment of CKD patients. We provide useful indications regarding acid load of food and drinks—the “acid load dietary traffic light”.

Blood pressure (BP) measurement is a simple, and reproducible methool and is easily accepted by patients. It is well known that in a single subject BP may change during the day; this fact is considered physiological by many physicians and does not influence the final estimated value of BP. However, it’s reasonable to suppose that blood pressure variability (BPV) has clinical consequences and that exists a cardiovascular risk related to it. In fact, recent observations indicate that BP variations could be responsible for organ damage associated with hypertension more than the systolic and diastolic BP. In this study, we aim to analyze and compare published data in literature concerning the presumable correlations between BP variability and outcomes, both in Chronic Kidney Disease (CKD) and End stage Renal Disease (ESRD). We conclude that BPV represents an important cardiovascular risk factor for both patients with CKD and for those in dialysis. No correlations were found between BPV and the progression of CKD. However, this is a retrospective study and more (RCTS) are needed on this topic.

Hemodialysis patients have a high cardiovascular mortality and hypertension is the most prevalent treatable risk factor. Hemodialysis is an unphysiological therapy respect to daily renal function, and the approach to avoid the related may be to increase dialysis frequency using a daily dialysis therapy. We analyze as the effect of more long or frequent weekly dialysis can improve the hypertension in hemodialysis patients.

The control of sodium intake, and the implementation of low sodium diet in nephrology clinical practice is very low, is difficult when salt have been implicated as targets for manipulation to limit progression of kidney disease. It is well recognized that better control of blood pressure is important in mitigating the progression of CKD. We describe the effects of Very Low protein Diet on intake of Sodium, and, consequently, on proteinuria and blood pressure.

Background. We investigated the effects of visit-to-visit systolic blood pressure variability (SBPV) on both mortality and dialysis inception in a cohort of chronic kidney disease (CKD) patients not requiring dialysis therapy. Furthermore, we also explored the carry-over effect of visit-to-visit SBPVon mortality after dialysis initiation. Methods. We conducted a longitudinal retrospective, observational, multi-centre study in three tertiary care nephrology outpatient clinics. All the ambulatory CKD patients admitted to the outpatient clinics from 1 January 2004 to 31 December 2005 were screened for study eligibility. We selected all consecutive patients older than 18 years of age with a mean estimated glomerular filtration rate of

Introduction: Serum concentrations of potassium (K) and calcium (Ca) influence ionic currents and play an important role in the duration of ventricular action potential. Further, the influence of alkalosis in reducing ionized calcium has been well known for a long time. The aim of this study was to assess the effects of different dialysate electrolytes and bicarbonate concentrations on changes of QTc interval in patients on chronic hemodialysis. Methods: The study hemodialysis sessions were performed in 22 patients, with different electrolyte and bicarbonate concentrations in dialysate. Tested dialysate concentrations were K of 2 and 3 mmol/L; Ca 1.25, 1.5 and 1.75 mmol/L; and bicarbonate 30 and 34 mmol/L. An electrocardiogram (ECG) was recorded 1 hour before, at the end and every hour for 4 hours after each study dialysis session. QTc interval was measured from the beginning of the QRS complex to the end of a T wave on a 12-lead ECG. Blood was collected and K, total Ca, ionic Ca and pH evaluated. Results: At the end of the study hemodialysis session with dialysate containing low K (2 mmol/L), low Ca (1.25 mmol/L) and high bicarbonate concentration (34 mmol), mean QTc interval was significantly prolonged compared with that recorded with dialysate containing high K (3 mmol/L), high Ca (1.75 mmol/L) and bicarbonate (30 mmol) (40 ± 10 milliseconds vs. 2 ± 2 milliseconds; p

We have already demonstrated that in chronic hemodialysis (HD) patients, the cyclic variations in both hydration status and blood pressure are responsible for changes in pulse wave velocity (PWV). The aim of this study is to verify whether the cyclic variation of PWV influences mortality in dialysis patients. We studied 167 oligoanuric (urinary output o500 mL/day) patients on chronic standard bicarbonate HD for at least 6 months. They performed 3 HD sessions of 4 hours per week. Patients were classified into 3 groups: normal PWV before and after dialysis (LL); high PWV before and normal PWV after dialysis (HL); and high PWV before and after dialysis (HH). The carotid-femoral PWV was measured with an automated system using the foot-to-foot method. Analysis of variance was used to compare the different groups. The outcome event studied was all-cause mortality and cardiovascular mortality. The PWV values observed were LL in 44 patients (26.3%); HL in 53 patients (31.8%); and HH in 70 patients (41.9%). The 3 groups of patients are homogenous for sex, age, and blood pressure. The HH group had a higher prevalence of (Po0.001) ASCVD. It is interesting that the distribution of patients in the 3 groups is correlated with the basal value of PWV. In fact, when the basal measure of PWV is elevated, there is a higher probability that an HD session cannot reduce PWV (o12 ms). A total of 53 patients (31.7%) died during the follow-up of 2 years: 5 patients in the LL group (11.4%); 16 in the HL group (30.2%); and 32 in the HH group (50.7%) (LL vs. HL, P =0.047; LL vs. HH, Po0.00001; HL vs. HH, P=0.034). We evidence for the first time that different behaviors of PWV in dialysis subjects determine differences in mortality.

Background: The subendocardial viability ratio (SEVR), calculated by pulse wave analysis, is an index of myocardial oxygen supply and demand. Here we analyze the relation between SEVR and cardiovascular mortality in the chronic kidney disease (CKD) population of a post hoc analysis of a multicenter, prospective, randomized, nonblinded study. Methods: We studied 212 consecutive asymptomatic outpatients receiving care at 12 nephrology clinics in south Italy. Inclusion criteria were age >18 years, 6 months of follow-up before the enrollment and stage 3-4 CKD. Results: During follow-up, 34 subjects died, 29 of them for cardiovascular causes. SEVR correlated inversely with vascular calcifications (r = -0.37) and myocardial mass (r = -0.45); SEVR changed from 1.33 ± 0.24 to 1.36 ± 0.16 (p = NS; baseline and final values, respectively) in living patients, and from 1.16 ± 0.31 to 0.68 ± 0.26 in deceased patients (p < 0.001). Kaplan-Meier curves show that that a greater reduction of SEVR values during the study (third tertile) significantly predicts cardiovascular mortality (p < 0.0001). Conclusions: This post hoc analysis shows that a reduction of SEVR values impacts cardiovascular mortality in CKD patients.

Objectives The aim of this study was to assess potential effects of high-tone external muscle stimulation (HTEMS) on parameters of endothelial dysfunction (ED) in patients with acute kidney injury (AKI). Background The bad outcome of AKI patients is markedly influenced by ED, microinflammation, oxidative stress and protein hypercatabolism. Recently, we have shown that intradialytic application of HTMS was associated with a faster resolution of AKI. Here, we investigated in the same cohort of patients whether parameters of ED such as nitric oxide (NO), asymmetric-dimethylarginine (ADMA), and endothelin 1 (ET-1) are modulated by HTEMS as compared to non-HTEMS-treated AKI patients. Methods In a post-hoc study we analyzed plasma samples of the 34 AKI patients stage 5, of whom 17 underwent intradialytic HTEMS treatment while the other 17 served as AKI dialysis controls. Measurements included plasma nitrate and nitrite (NOx), ADMA, ET-1 and were performed before and on days 3, 7, 14, 21, and 28 after start of daily dialysis. Additional 16 healthy volunteers served as controls. Results Initially, in both AKI groups NOx levels were markedly lower and ADMA and ET-1 levels were higher compared to the healthy controls. After initiation of daily hemodialysis the HTEMS group showed a faster improvement of NOx and ET-1 (after 1 week) and ADMA levels (after 2 weeks) compared to the No- HTEMS group. After 2 weeks, all parameters of the HTEMS group were not different from healthy controls, while the No-HTEMSAKI group needed 3 - 4 weeks. Conclusion Our findings suggest for the first time that in AKI patients, application of HTEMS is associated with a faster normalization of lowered NOx and elevated ADMA and ET-1 plasma levels. We hypothesize that the more rapid amelioration of these parameters in the HTEMS group contributed to the accelerated recovery of AKI. With regard to the small study groups with different causes of AKI, investigations in a greater number of AKI patients is required.

Background and Objectives: High levels of indoxyl sulfate (IS) are associated with chronic kidney disease (CKD) progression and increased mortality in CKD patients. The aim of this pilot study was to assess whether a very low protein diet (VLPD; 0.3 g/kg bw/day), with a consequent low phosphorus intake, would reduce IS serum levels compared to a low protein diet (LPD; 0.6 g/kg bw/day) in CKD patients not yet on dialysis. Material and Methods: This is a post hoc analysis of a preceding cross-over study aimed to analyze FGF23 during VLPD. Here we performed a prospective randomized controlled crossover study in which 32 patients were randomized to receive either a VLPD (0.3 g/kg bw/day) supplemented with ketoanalogues during the first week and an LPD during the second week (group A, n = 16), or an LPD during the first week and a VLPD during the second week (group B, n = 16 patients). IS serum levels were measured at baseline and at the end of each study period. We compared them to 24 hemodialysis patients (HD) and 14 healthy subjects (control). Results: IS serum concentration was significantly higher in the HD (43.4 ± 12.3 µM) and CKD (11.1 ± 6.6 µM) groups compared to the control group (2.9 ± 1.1 µM; p < 0.001). IS levels also correlated with creatinine values in CKD patients (R2 = 0.42; p < 0.0001). After only 1 week of a VLPD, even preceded by an LPD, CKD patients showed a significant reduction of IS serum levels (37%). Conclusions: VLPD supplemented with ketoanalogues reduced IS serum levels in CKD patients not yet on dialysis.

Hypertension is responsible for a significantly increased burden of cardiovascular events and it is cause and a consequence of Chronic Kidney Disease (CKD) and a determinant factor in its progression to End Stage Kidney Disease (ESKD). Therefore, nephrologists have been focusing their attention on hypertension control to prevent CKD progression, delaying it but with poor results on cardiovascular mortality reduction. An important effect is the difficulty to adequately reduce BP levels in CKD patients and especially in dialysis patients despite the polipharmacological therapy. We have to take into account other aspects influencing mortality risk in CKD patients .The first aspect to consider is whether brachial blood pressure (BP) measurement is sufficient to describe the complex relationship between the alteration of BP and outcomes in renal subjects. The second aspect to consider is the variability of BP (BPV). We think that BP measurement cannot only take into account brachial BP, because it represents a limited measure of a complex clinical condition in CKD or ESRD patients. The inability to evaluate hypertension in its complexity explains why several aspects are still unrecognized.

Summary Background and objectives High levels of fibroblast growth factor 23 are associated with mortality, CKD progression, and calcification in CKD patients. The aim of this pilot study is to assess whether a very-low-protein diet (0.3 g/kg per day) with a consequent low intake of phosphorus would reduce fibroblast growth factor 23 compared with a low-protein diet (0.6 g/kg per day) in CKD patients not yet on dialysis. Design, setting, participants, & measurements A prospective, randomized, controlled crossover study was performed in which 32 patients were randomized into two groups. Group A (16 patients) received a very-low-protein diet (0.3 g/kg body wt per day) supplemented with ketoanalogues during the first week and a low-protein diet during the second week, and group B (16 patients) received a low-protein diet during the first week and a very-low-protein diet during the second week. Fibroblast growth factor 23, seric, and urinary phosphate levels were measured at baseline and the end of each study period. Results After only 1 week of the very-low-protein diet, reductions in fibroblast growth factor 23 levels (33.5%), serum phosphate (12%), and urinary phosphate (34%) with the very-low-protein diet compared with the low-protein diet were observed. Serum and urinary phosphate levels and protein intake were significant determinants of fibroblast growth factor 23 (95% confidence interval=1.04–1.19, 1.12–1.37, and 1.51–2.23, respectively). Conclusions A very-low-protein diet supplemented with ketoanalogues reduced fibroblast growth factor 23 levels in CKD patients not yet on dialysis.

Pulse wave velocity (PWV) is a predictor of morbidity and mortality in patients with end-stage renal disease (ESRD). Dialysis patients show cyclic changes in PWV related to their hydration status and blood pressure. Our aim is to assess the impact of daily dialysis on PWV. We performed a randomized crossover study of 60 patients who underwent standard hemodialysis (HD) three times per week for at least 6 months. Patients were classified into three groups according to their PWV values before (pre-) and after (post-) HD, with a cutoff value of 12 m s(-1), as follows: the low-low (LL) group had normal pre-HD and post-HD PWV; the high-low (HL) group had high pre-HD PWV and normal post-HD PWV; and the high-high (HH) group had high pre- and post-HD PWV. All patients continued standard HD for 2 weeks. A total of 10 patients from each group were randomly assigned to continue standard HD for 1 week and then underwent daily dialysis for 1 week. The remaining 10 patients underwent daily dialysis for 1 week and then underwent standard HD for 1 week. PWV values were measured before and 1 h after each dialysis session. With daily dialysis treatment, 2 of 20 patients (10%) moved from the PWV-HH group to the PWV-HL group, whereas 18 of 20 patients (90%) moved from the PWV-HL group to the PWV-LL group (P = 0.030). Daily dialysis reduces PWV in the ESRD patients. As PWV is a strong predictor of mortality in ESRD and has cyclic variations in patients who are on standard HD, we believe that daily dialysis may be used in patients with high PWV levels to reduce their mortality risk.

Background: Hemodialysis patients have a high car- diovascular mortality, and hypertension is the most prevalent treatable risk factor. We aimed to assess the predictive significance of dialysis-to-dialysis variabil- ity in blood pressure in hemodialysis patients. Methods: We performed a historical cohort study in 1,088 prevalent hemodialysis patients, followed up for 5 years. The risk of cardiovascular death was determined in relation to dialysis-to-dialysis variability in blood pressure, maximum blood pressure and pulse pressure. Results: Variability in blood pressure was a predictor of cardiovascular death (hazard ratio (HR) = 1.242; 95% confidence interval (95% CI), 1.004-1.537; p=0.046). Also age (HR=1.021; 95% CI, 1.011-1.048; p=0.049), diabetes (HR=1.134; 95% CI, 1.128-1.451; p=0.035), creatinine (HR=0.837; 95% CI, 0.717-0.977; p=0.024) and albumin (HR=0.901; 95% CI, 0.821-0.924; p=0.022) influenced mortality. Maximum blood pressure and pulse pressure did not show any effect on cardiovascular death. Conclusion: Dialysis-to-dialysis variability in blood pressure is a predictor of cardiovascular mortality in hemodialysis patients, and blood pressure variability may be used in managing hypertension and predicting outcomes in dialysis patients.