Ramipril and Cardiovascular Outcomes in Patients on Maintenance Hemodialysis: The ARCADIA Multicenter Randomized Controlled Trial.

Background And Objectives: Renin-angiotensin system (RAS) inhibitors reduce cardiovascular morbidity and mortality in patients with CKD. We evaluated the cardioprotective effects of the angiotensin-converting enzyme inhibitor ramipril in patients on maintenance hemodialysis.

Design, Setting, Participants, & Measurements: In this phase 3, prospective, randomized, open-label, blinded end point, parallel, multicenter trial, we recruited patients on maintenance hemodialysis with hypertension and/or left ventricular hypertrophy from 28 Italian centers.

Effects of valsartan, benazepril and their combination in overt nephropathy of type 2 diabetes: A prospective, randomized, controlled trial.

Aims: To evaluate whether angiotensin-converting enzyme (ACE) inhibitor and angiotensin II receptor blocker (ARB) combination therapy is more nephroprotective than ACE inhibitor or ARB monotherapy in people with type 2 diabetes and overt nephropathy.

Materials And Methods: In this prospective, randomized, open, blind-endpoint phase III trial sponsored by the Italian Drug Agency, 103 consenting patients with type 2 diabetes, aged >40 years, with serum creatinine levels 159 to 309 μmol/L, spot morning urinary albumin-creatinine ratio > 1000 mg/g (or > 500 mg/g in those on ACE inhibitor or ARB therapy at inclusion) were stratified by centre and randomized to 4.5-year treatment with valsartan 320 mg/d (n = 36), benazepril 20 mg/d (n = 34) or halved doses of both medications (n = 33).

The PIRP project (Prevenzione Insufficienza Renale Progressiva): how to integrate hospital and community maintenance treatment for chronic kidney disease.

Chronic kidney disease (CKD) represents a global health burden with great economic impact on healthcare and therefore it requires appropriate interventions by Health Care Systems. The PIRP (Prevenzione Insufficienza Renale Progressiva) project is endorsed and funded by the Emilia-Romagna Regional Health Board and involves all the Nephrology Units of the Emilia-Romagna Region (Italy). The project has a predominantly clinical purpose and is expected to bring about a continuous quality improvement in the treatment of patients with CKD.

[Challenges and results of the PIRP project (Prevenzione della Insufficienza Renale Progressiva) of the Emilia-Romagna Region].

The PIRP project was conceived in 2004; with the aim to face the increased prevalence of chronic kidney disease (CKD) associated with the aging and increased survival of the population. The first phase of the project consisted of training primary care physicians to identify people at risk of CKD and to implement intervention strategies that proved to be effective in preventing CKD it or delaying its progression once it is established. In the second phase of the project, dedicated ambulatories were opened in the nephrology units of Emilia-Romagna hospitals to provide an in-depth assessment and personalized care to CKD patients, following them up until renal failure or death or referring them back to general practitioners, according to the study protocol.

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).

[Evolution and physical principles of convection-based dialysis treatment].

In the late 1960s, ultrafiltration was first used in clinical settings to increase, by convection, the clearance of toxic solutes in patients undergoing dialysis. Unfortunately, the efficiency of convection-based dialysis treatment, or hemofiltration (HF), was limited by the relatively low ultrafiltration coefficient of the dialyzers available at the time. Thus, the exchanged volume was low, and the corresponding clearance of low-molecular-weight solutes was insufficient with respect to the current target value of Kt/V urea.

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.

Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD.

Symptomatic intradialytic hypotension is a common complication of hemodialysis (HD). The application of convective therapies to the outpatient setting may improve outcomes, including intradialytic hypotension. In this multicenter, open-label, randomized controlled study, we randomly assigned 146 long-term dialysis patients to HD (n = 70), online predilution hemofiltration (HF; n = 36), or online predilution hemodiafiltration (HDF; n = 40).

Effects of add-on fluvastatin therapy in patients with chronic proteinuric nephropathy on dual renin-angiotensin system blockade: the ESPLANADE trial.

Background And Objectives: This open, prospective, randomized trial aimed to assess the effects of statins in chronic kidney disease patients on optimized antiproteinuric treatment with combined angiotensin-converting enzyme inhibition and angiotensin receptor blockade.

Design, Setting, Participants, & Measurements: After 1-month benazepril therapy followed by 1-month benazepril-valsartan combined therapy (run-in), 186 consenting patients with residual proteinuria >0.5 g/24 h were randomized to 6-month benazepril-valsartan therapy alone or combined with fluvastatin.

A simple approach for assessing equilibrated Kt/V beta 2-M on a routine basis.

Background: Large observational studies have shown a reduction in morbidity and mortality in patients on high-flux haemodialysis (HD) or convective techniques, compared with low-flux HD. An index to evaluate treatment efficiency in middle molecule (MM) removal would be recommended. Since beta-2-microglobulin (beta2-M) is a recognized MM marker, we evaluated an easy approach for Kt/V(beta2-M) assessment on a routine basis, avoiding other complex methods.

Urea in exhaled breath condensate of uraemics and patients with chronic airway diseases.

Exhaled breath condensate (EBC) is composed mainly by water and also contains non-volatile mediators, which are expired in small droplets of airway fluid. Urea has been proposed as a normalization factor for EBC non-volatile biomarkers. Aim of this study was to assess volatility and diffusivity of urea ex vivo and to measure its EBC concentrations in different clinical conditions.

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).

Iron-replete hemodialysis patients do not require higher EPO dosages when converting from subcutaneous to intravenous administration: results of the Italian Study on Erythropoietin Converting (ISEC).

Background: Previous studies reported significant increases in epoetin dosages when converting hemodialysis patients from subcutaneous (SC) to intravenous (IV) administration. More recent studies that corrected for iron deficiency found a much lower, if any, increase in epoetin dosage and/or decrease in hemoglobin (Hb) level after conversion from SC to IV epoetin administration. Therefore, the matter is still open for debate.

Organic contamination in dialysis water: trichloroethylene as a model compound.

Background: Routine water monitoring in a haemodialysis centre revealed high trichloroethylene (TCE) concentrations. The aim of this study is to describe the measures adopted after organic contamination of dialysis water in order to avoid the possibility of patient exposure. We also carried out in vitro experiments to evaluate the accumulation of TCE in various devices normally used in a dialysis water treatment system (DWTS).

Clinical effects of online dialysate and infusion fluids.

Online hemodiafiltration appears to be the most effective technique of renal replacement therapy in many respects. Removal of small and high-molecular weight substances is enhanced. Modern technology ensures a safe, online production of reinfusion fluids.

Comparison of 3 automated assays for C-reactive protein in end-stage renal disease: clinical and epidemiological implications.

Chronic inflammation has been repeatedly reported in individuals undergoing hemodialysis. C-reactive protein (CRP) is considered a marker of chronic inflammation, as well as a mediator of the atherosclerotic process. Clinical and epidemiologic studies are based on plasma values obtained with the use of various automated methods.

Urinary soluble CD14 mediates human proximal tubular epithelial cell injury induced by LPS.

Renal proximal tubular epithelial cells (PTEC) are target for LPS during sepsis and renal infections. In the present study, we evaluated whether stimulation of human PTEC by LPS is modulated through the soluble or the membrane form of the LPS receptor CD14. We found that PTEC lacked expression of the membrane form of CD14 and did not release soluble CD14 (sCD14).