Phosphate levels in patients treated with low-flux haemodialysis, pre-dilution haemofiltration and haemodiafiltration: post hoc analysis of a multicentre, randomized and controlled trial.

BACKGROUND: Whether convective therapies allow better control of serum phosphate (P) is still undefined, and no data are available concerning on-line haemofiltration (HF). The objectives of the study are to evaluate the effect of convective treatments (CTs) on P levels in comparison with low-flux haemodialysis (HD) and to evaluate the correlates of serum phosphate in a post hoc analysis of a randomized clinical trial. METHODS: This analysis was performed in the database of a multicentre, open label and randomized controlled study in which 146 chronic HD patients from 27 Italian centres were randomly assigned to HD (70 patients) or CTs: on-line pre-dilution HF (36 patients) or on-line pre-dilution haemodiafiltration (40 patients). RESULTS: CTs did not affect P (P = 0.526), calcium (Ca) (P = 0.849) and parathyroid hormone levels (P = 0.622). P levels were associated with the use of phosphate binders including aluminium-based phosphate binders (P < 0.001) and sevelamer (P < 0.001), pre-dialysis bicarbonate levels (P < 0.001) and pre-dialysis blood K levels (P < 0.001). On multivariate analysis (generalized linear model), serum P was again largely unassociated with CTs (P = 0.631). Notably, participating centres were by far the strongest independent correlate of serum P, explaining 45.3% of the variance of serum P over the trial and this association was confirmed at multivariate analysis. Bicarbonate (P < 0.001) and, to a weaker extent, serum K (P = 0.032) were independently related to serum P. CONCLUSIONS: In comparison with low-flux HD, CTs did not significantly affect serum P levels. Participating centres were the main source of P variability during the trial followed by treatment with phosphate binders, serum bicarbonate and, to a weak extent, serum potassium levels (ClinicalTrials.gov Identifier: NCT011583309).

Predictors of haemoglobin levels and resistance to erythropoiesis-stimulating agents in patients treated with low-flux haemodialysis, haemofiltration and haemodiafiltration: results of a multicentre randomized and controlled trial.

BACKGROUND: Predictors of haemoglobin (Hb) levels and resistance to erythropoiesis-stimulating agents (ESAs) in dialysis patients have not yet been clearly defined. Some mainly uncontrolled studies suggest that online haemodiafiltration (HDF) may have a beneficial effect on Hb, whereas no data are available concerning online haemofiltration (HF). The objectives of this study were to evaluate the effects of convective treatments (CTs) on Hb levels and ESA resistance in comparison with low-flux haemodialysis (HD) and to evaluate the predictors of these outcomes. METHODS: Primary multivariate analysis was made of a pre-specified secondary outcome of a multicentre, open-label, randomized controlled study in which 146 chronic HD patients from 27 Italian centres were randomly assigned to HD (70 patients) or CTs: online pre-dilution HF (36 patients) or online pre-dilution HDF (40 patients). RESULTS: CTs did not affect Hb levels (P = 0.596) or ESA resistance (P = 0.984). Hb correlated with polycystic kidney disease (P = 0.001), C-reactive protein (P = 0.025), ferritin (P = 0.018), ESA dose (P < 0.001) and total cholesterol (P = 0.021). The participating centres were the main source of Hb variability (partial eta(2) 0.313, P < 0.001). ESA resistance directly correlated with serum ferritin (P = 0.030) and beta2 microglobulin (P = 0.065); participating centres were again a major source of variance (partial eta(2) 0.367, P < 0.001). Transferrin saturation did not predict either outcome variables (P = 0.277 and P = 0.170). CONCLUSIONS: In comparison with low-flux HD, CTs did not significantly improve Hb levels or ESA resistance. The main sources of variability were participating centres, ESA dose and the underlying disease.

Automatic adaptive system dialysis for hemodialysis-associated hypotension and intolerance: a noncontrolled multicenter trial.

BACKGROUND: Hemodialysis is complicated by a high incidence of intradialytic hypotension and disequilibrium symptoms caused by hypovolemia and a decrease in extracellular osmolarity. Automatic adaptive system dialysis (AASD) is a proprietary dialysis system that provides automated elaboration of dialysate and ultrafiltration profiles based on the prescribed decrease in body weight and sodium content. STUDY DESIGN: A noncontrolled (single arm), multicenter, prospective, clinical trial. SETTING & PARTICIPANTS: 55 patients with intradialytic hypotension or disequilibrium syndrome in 15 dialysis units were studied over a 1-month interval using standard treatment (642 sessions) followed by 6 months using AASD (2,376 sessions). INTERVENTION: AASD (bicarbonate dialysis with dialysate sodium concentration and ultrafiltration rate profiles determined by the automated procedure). OUTCOMES: Primary and major secondary outcomes were the frequency of intradialytic hypotension and symptoms (hypotensive events, headache, nausea, vomiting, and cramps), respectively. RESULTS: More stable intradialytic systolic and diastolic blood pressures with lower heart rate were found using AASD compared with standard treatment. Sessions complicated by hypotension decreased from 58.7% ± 7.3% to 0.9% ± 0.6% (P < 0.001). The incidence of other disequilibrium syndrome symptoms was lower in patients receiving AASD. There were no differences in end-session body weight, interdialytic weight gain, or presession natremia between the standard and AASD treatment periods. LIMITATIONS: A noncontrolled (single arm) study, no crossover from AASD to standard treatment. CONCLUSIONS: This study shows the long-term clinical efficacy of AASD for intradialytic hypotension and disequilibrium symptoms in a large number of patients and dialysis sessions.

[Kidney biopsy in Mantua: 2000-2009 report]. / Biopsie renali a Mantova: report 2000-2009.

The aim of this study was to report the frequency of kidney diseases related to gender, age, clinical presentation and renal function at the time of kidney biopsy in the population of Mantua province (400,000 residents). We collected the results of 132 real-time ultrasound-guided fine-needle (18 G) kidney biopsies by optical and immunofluorescence microscopy. The clinical presentation at the time of biopsy was nephrotic syndrome in 57%, nephritic syndrome in 22%, and urinary abnormalities in 21% of cases. Serum creatinine was >-1.5 mg/dL in 48% of patients. Membranous nephropathy was the most frequent histological finding (21.4%), followed by IgA nephropathy (14.5%), focal glomerulosclerosis (11.5%), diabetic nephropathy (8.4%), and chronic interstitial nephritis (6.9%). Primary glomerulonephritis including membranous glomerulonephritis and IgA nephropathy showed a male predominance. The pathological correlations in native biopsy-proven renal disease provided useful information for clinical practice. The histological findings in our patient series are similar to those recorded in Italian and European registries. A less invasive policy in the case of isolated urinary abnormalities and a normal eGFR resulted in a lower incidence of IgA nephropathy in our series than was recorded in the national Italian registry.

Chronic kidney disease certification process manual by the Italian Society of Nephrology (SIN): Part I: clinical care delivery and performance measurements and improvement.

Chronic kidney diseases (CKD) has now emerged as a public health priority, and there is an increasing demand by patients and health care organisations that the quality of care delivered by renal units to CKD patients be systematically monitored and evaluated. The Italian Society of Nephrology (SIN) has started an initiative aimed at promoting a quality certification process specifically focused on CKD. To this end, SIN started a collaboration with an independent Italian company which is a partner of Joint Commission International (JCI), a nonprofit international organisation dedicated to the promotion of quality improvement and safety of health services. As a result of this collaboration, a document describing a voluntary certification process developed based on JCI criteria was produced by SIN. This document comprises 2 parts. Herein (Part I) we deal with standards for clinical care delivery and performance measurements related to CKD care. Programme management and clinical information management will be presented in a separate manuscript (Part II).

Chronic kidney disease certification process manual by the Italian Society of Nephrology (SIN): part II: programme management and clinical information management.

This is the second part of a document describing a voluntary certification process based on Joint Commission International (JCI) criteria developed by the Italian Society of Nephrology (SIN) and JCI representatives. In the first part we discussed standards for clinical care delivery and performance measurements related to chronic kidney disease care. Herein (Part II), we complete the description of Performace measurements and CKD care by describing issues related the management and clinical information management.

[Stocking process for consumables and investement goods in the Italian public health service (part II)]. / Il processo di approvvigionamento di beni di consumo e di beni di investimento nelle aziende sanitarie pubbliche (parte II).

The necessity for fairness and transparency during the processes of supply of consumables and capital goods within the Italian Health Service together with that of containing costs in line with budget reductions, are points outlined in the 2006 public and European Union allocation codes and related procedures. These include methods to guarantee open, limited negotiation both without or after the official announcement for competitive bidding has been made, plus mediation and framework agreement. The publicizing of announcements of bidding to potential Health Service suppliers, criteria for applicant selection and selection of personnel to comprise the panels who effectively make the choice of suppliers, are all phases that are carefully regulated at a legal level. Even small expenditures (down to 20,000) are covered by these regulations. An overview of specific responsibilities, the institution of boards of physicians and the application of sanctions ends the present review.

[Stocking process for consumables and investement goods in the public health service (first part)]. / Il processo di approvvigionamento di beni di consumo e di beni di investimento nelle aziende sanitarie pubbliche (parte prima).

Hospital procedures to stock tools and equipment supplies for day-by-day clinical diagnosis and treatment place physicians to face up with their ones responsibilities. Nephrologists have to deal with dialysis machines, related technology updating and associated consumables. Overall they have to cope with local health service reality, which looks for progressive doctors skill improvement at lowest or no cost at all. Aim of the first part of this review is to analyze all these issues according European Union, Italian and local main lines and associated laws. Moreover, will be reviewed purchase strategies always looking at patient wellness as final aim of the entire process. They will be illustrated sequences of administrative measures, recent Central Commissioning Headquarters, and laws that since 2006 have defined the related procedures (i.e. open, limited, negotiated, and competitive).

Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia.

BACKGROUND: In the management of anemia in patients with chronic kidney disease stage 5 undergoing dialysis (CKD-5D), maintaining hemoglobin (Hb) within the range recommended by the guidelines is challenging. METHODS: The CARISMA study aim was to evaluate the efficacy, safety and tolerability of a once-monthly continuous erythropoietin receptor activator (CERA) for the treatment of anemia in CKD-5D patients. In this single-arm, multicenter, open-label, phase IIIb study, we screened adult patients from 66 centers in Italy receiving intravenous epoetin alfa or beta or darbepoetin alfa. Eligible patients entered the CERA dose titration phase (DTP), followed by an efficacy evaluation period (EEP) and a long-term safety period (LTSP). Patients were analyzed by intention-to-treat (ITT), per protocol (PP) and safety populations. RESULTS: The rate of patients maintaining Hb within the range 10.0-12.0 g/dL throughout the EEP was 63.22% (220/348), and concentration from baseline to any postbaseline time point. CERA may thus offer a convenient and effective treatment 73.94% (122/165) in the ITT and PP population, respectively, periods in both populations. The rate of patients requiring a dose change was higher during the DTP (69.2%) and the LTSP (73.0%) than during the EEP (54.5%), as expected. CERA treatment was generally well tolerated. CONCLUSIONS: Once-monthly CERA administered to CKD-5D patients was associated with negligible changes in mean Hb option for these patients.

[Production and control of water quality for hemodialysis]. / Produzione e controllo della qualita' dell'acqua per emodialisi.

Certain substances present in drinking water can harm hemodialysis patients if they are not removed before the preparation of the dialysate. An optimal water treatment system includes tap water pretreatment and a double reverse osmosis process. Every component, including the delivery of the treated water to the dialysis machines, contributes to preventing chemical and microbiological contamination. Quality standards for dialysis water do not differ from those for intravenous drug safety and the progress toward the goals depends on practical solutions to important issues, including how the standard is to be applied and whether it should be limited to substances with well-documented toxicity in hemodialysis patients, and how microbiological contaminants should be handled. Meeting the standards for the new dialysis methods and membranes requires protocols for the development of a facility-specific quality management system to ensure dialysate quality based on the validation of system performance coupled with routine monitoring and periodic revalidation.

[Chronic kidney disease in the province of Mantua and its developments over the last 40 years]. / Evoluzione della malattia renale cronica nella provincia di Mantova in 40 anni.

The incidence and prevalence of end-stage renal disease increased steadily for 35 years in the population of Italy's Mantua province until the end of 2007, when they started to decrease. We describe the results of providing information and raising awareness among residents of the province's capital, Mantua, and of direct teaching and short training courses in hospital wards for general practitioners over a period of 3 years. During this period there was also more consultation activity for all kidney outpatients, from the first to the last stages of chronic kidney disease. Clinical data collected by the local NHS section (ASL) showed an increase in age and comorbidities (mainly type 2 diabetes) in kidney patients. As a result of the preventive measures, there has been an effective reduction of the yearly incidence and prevalence for all kinds of treatment, with the exception of kidney transplants, which have increased progressively during the last years.

Burnout in health care providers of dialysis service in Northern Italy--a multicentre study.

BACKGROUND: Few data are available regarding the prevalence of burnout among dialysis health care workers. Aims of the present study were to assess and compare burnout levels in a sample of nurses and physicians working in dialysis units, and to investigate their relationships with quality of life, in a cross-sectional observational study. METHODS: A total of 344 workers from 10 dialysis centres in Northern Italy completed a battery of questionnaires including the Maslach Burnout Inventory, the MOS-36 Item Short Form Health Survey [SF36: physical (PCS) and mental (MCS) component scores] and the 30-item General Health Questionnaire (GHQ30). Data on social and demographic characteristics and working conditions were also collected. General Estimating Equations models were used for the analysis. RESULTS: Overall, burnout scores were lower than the Italian normative sample, with no significant differences between physicians and nurses. However, 30% of nurses had high emotional exhaustion vs 18% of physicians (adjusted OR 2.38, P = 0.003). Emotional exhaustion was also predicted by number of worked hours and months worked in dialysis in the previous 2 years. Depersonalisation was predicted by male gender and bad relationship with coworkers. Having no children and having a permanent hospital position predicted low personal accomplishment. PCS was lower in nurses (50.0 vs 53.3, P < 0.001), while no significant difference was found for MCS and GHQ30. Lower PCS was associated with emotional exhaustion (P = 0.007) and GHQ30 > 5 with depersonalization (P = 0.032). CONCLUSIONS: Although burnout is not a general problem in dialysis health care providers, a subgroup of them may be identified, who would benefit from supportive measures to prevent this condition. Nurses appeared more burned-out in the emotional exhaustion scale than physicians.