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Biomedical subjects

F Locatelli

Publications and source records attributed to F Locatelli.

At least 469 records · Page 26Linked to original sources
PubMedDate not supplied

Technical-economic management models in dialytic treatment: an evolving reality. The Italian experience.

Health care organisations and financial factors (particularly treatment reimbursement rates) may influence the management of ESRD. We analysed the organisation of renal replacement therapy (RRT) in Italy, focusing on RRT population trends, patient distribution by treatment modality and provision, reimbursement rates, accreditation and quality control. Data from the Italian Dialysis and Transplant Registry and market research studies indicate that Italy has one of the highest dialysis and treatment acceptance rates in Europe. There is a high rate of hemodialysis (HD) and good use of peritoneal dialysis (PD), whereas the prevalence of transplanted patients is lower than the European mean. Dialytic treatment in private centers is limited by law to HD (mainly in Central-Southern Italy) and covers nearly 25-30% of the demand for RRT which means that, although Italy has a public national health care system, the provision of RRT is based on a "mixed" model. Regions with a higher prevalence of "private" dialysis have more dialysis centers, but a lower prevalence of PD since it is not permitted in private facilities, and fewer transplanted patients. The "public" system is not an automatic guarantee of quality and efficacy, and the "private" system is not necessarily a synonym of poor quality treatment due to its need to make a profit. The coexistence of private and public facilities (if well balanced and integrated) may in fact help overcoming bureaucracy in the public administration in relation to the demand for innovation and improving performances by means of fair competition.

Accreditation↗
PubMedDate not supplied

The renoprotective effect of combined antihypertensive drugs.

In recent years, a target blood pressure (BP) of at least 125/75 mmHg has been sought in order to reduce the rate of progression of chronic renal failure (CRF) and cardiovascular mortality. Some antihypertensive agents, such as ACE inhibitors, calcium channel blockers and angiotensin receptor antagonists (and perhaps endothelin converting enzyme inhibitors and endothelin antagonists), may also reduce CRF progression because they block some of the pathogenetic mechanisms involved in renal damage. Although this effect seems to be partially independent of BP reduction, it is still not clear whether these drugs are really superior to other antihypertensive agents when low BP is achieved. However, the possibility that combination treatments with some of these drugs may confer additive or even synergistic renoprotective effects other than BP control is not only fascinating, but also important because multidrug antihypertensive regimens are required anyway to manage BP adequately in the majority of patients with CRF.

Angiotensin Receptor Antagonists↗
PubMedDate not supplied

TT virus infection in end-stage renal disease (ESRD).

TT virus is a novel hepatitis-associated DNA virus that has been provisionally designated as transfusion-transmitted virus (TTV). Infection by TTV has been frequently demonstrated in humans. Few reports, however, have been published on the epidemiology of TTV infection in patients with ESRD. The prevalence of TTV in patients undergoing maintenance dialysis varies widely and various demographic, virologic or clinical features can explain these differences; in some series, the prevalence of TTV in HD was significantly higher than in control groups. Blood transfusion requirement and nosocomial transmission of TTV within dialysis units seem to be important in the diffusion of TTV in the HD setting; however, other routes of TTV acquisition may play a role. The clinical significance related to the presence of TTV in HD population remains unclear; it is possible that TTV may aggravate liver disease caused by hepatitis C virus (HCV) infection. The natural history of TTV in dialysis is an area of avide research, since TTV has a propensity for establishing long-term infection in HD patients. The possibility that TTV causes pathological changes outside the liver cannot be ruled out. Further studies are in progress to understand the natural history and the epidemiology of TTV infection in patients with ESRD.

Comorbidity↗
PubMedDate not supplied

Effect of sodium pool changes on blood pressure in patients undergoing PFD: design of a prospective randomized multicenter trial.

Blood pressure control is important during dialysis and the interdialytic period because of the frequency and potential seriousness of hypotension and hypertension. Water and sodium removal play an important role in the genesis of intradialytic cardiovascular instability or hypertension. Changing dialysate sodium concentrations without the aid of a kinetic model can sometimes give good results but is only an empirical approach. Therefore, this clinical trial was designed to prospectively investigate the advantages of changes in the sodium pool on the blood pressure profile of patients undergoing paired filtration dialysis (PFD). The hypothesis to be tested is whether using a dialysate conductivity which, according to the conductivity kinetic model, ensures that the conductivity of the ultrafiltrate at the end of each dialysis session is 0.3 mS/cm more (B) or less (C) than the mean during the run-in period, improves blood pressure control either in patients prone to intradialytic hypotension or patients who are hypertensive or normotensive with antihypertensive treatment. Patients will be randomly allocated to one of two treatment sequences (where treatment A is standard PFD): AABB or ABAA for patients with intradialytic hypotension; AACC or ACAA for hypertensive patients. During the experimental phase arterial blood pressure will be measured and symptoms reported by the patients will be recorded.

Blood Pressure↗
PubMedDate not supplied

Evaluation of dialysis outcomes: experimental versus observational evidence.

Evidence-based medicine provides tools to evaluate dialysis outcomes by integrating knowledge obtained from interventional and observational studies. This is illustrated in relation to three important topics: dialysis membranes, dialysis dose and anemia. Clinical trials and observational evidence support each other in indicating a decrease in dialysis-related amyloidosis morbidity when high-flux dialysis is used, whereas the impact of dialysis membranes on mortality is still controversial. Two clinical trials are currently investigating this issue: the American Hemodialysis (HEMO) Study and the European Membrane Permeability and ESRD Patient Outcome (MPO) Study. As indicated by the National Cooperative Dialysis Study (NCDS), dialysis dose is an important determinant of patient outcome. Although Gotch's analysis of the NCDS showed no further benefits for Kt/V>0.9, the analysis by Keshaviah showed a progressive benefit as Kt/V increased beyond 0.9. This finding has been confirmed by observational studies, of which the Dialysis Outcome and Practice Patterns Study (DOPPS) is the most recent and interesting. Further information is also expected from the HEMO study. The findings of observational and interventional studies are consistent in indicating anemia as a major determinant of morbidity and mortality in dialysis patients. American and European guidelines advise hemoglobin levels of 11-12 g/dl and hematocrit levels of 33-36%. The real benefit of completely correcting anemia is not so clear. In conclusion, far from being in opposition, clinical trials and observational studies can provide an integrated contribution to the analysis of dialysis outcomes.

Anemia↗
PubMedDate not supplied

[Immunosuppressive therapy in IgA glomerulonephritis with chronic renal failure: case study presentation and literature review].

Immunosuppressive treatment of IgA Nephropathy (IgAN) with chronic renal failure (CRF) is still a controversial issue, because of scepticism on expected results and possible side effects of therapy. There is a "point of no return" (serum creatinine of 3 mg/dL), after which the deterioration of renal function becomes inevitable. We report the case of a 24-year-old woman, with advanced IgAN (serum creatinine > 3 mg/dL), who experienced remission of proteinuria and long-lasting stabilisation of renal function, after treatment with a 6-month steroid course. Literature information on the therapy for advanced phases of IgAN is inadequate. Our multicenter randomised controlled trial, aimed at evaluating the effects of a 6-month steroid course, included 18 patients with mild CRF at baseline. The ten patients that we treated experienced better renal survival than the eight patients who received no steroids, with an expected renal survival of 29.5 and 6.5 years, respectively. In a prospective study of patients with serum creatinine of 1.6 - 2.9 mg/dl, Ballardie and Roberts compared 19 patients treated with immunosuppressive drugs and 19 control patients: renal survival at 5 years was 72% in treated and 5% in control patients. Goumenos et al. retrospectively evaluated 39 patients treated with steroids and azathioprine and 22 untreated patients: a non-progressive course was observed in 79.5% of treated patients and in 36% of untreated patients. Tsuruya et al. retrospectively examined 26 patients treated with steroids and cyclophosphamide and 19 untreated patients: the expected renal survival was of 5.2 years in treated and 4.8 years in untreated patients, respectively. Prospective controlled trials are essential for evaluating the real effectiveness of immunosuppressive therapy in IgAN patients with impaired renal function. We have recently proposed a study to compare steroids alone and steroids plus azathioprine, because it is mandatory to look for safe and effective therapies that delay as much as possible the start of dialysis, also in patients with already established CRF.

Adult↗
PubMedDate not supplied

[Pharmacological prevention of kidney diseases].

CRF increases its incidence and prevalence, with increased social and cost burden, while life expectance decreases, mainly due to cardiovascular comorbidity. Recent clinical studies demonstrated the slowing of the renal damage by low - protein diet and the reduction of proteinuria by lowering blood pressure. A good control of anemia and calcium - phosphate balance reduces the cardiovascular risks. Stopping smoking improves survival but lipid-lowering and anti-inflammatory drugs need more studies. It has been demonstrated that an early intervention of nephrology care reduces morbidity and mortality (illness and death incidence) and reduces costs.

Anemia↗
PubMedDate not supplied

Granular acute lymphoblastic leukemia in children. "Aieop Cooperative Group for Cytology of Acute Leukemias".

BACKGROUND: Granular acute lymphoblastic leukemia (ALL) is a rare morphological variant of ALL, characterized by cytoplasmic azurophil granules or inclusions, positive for aspecific esterase and acid phosphatase, with heterogeneous features at the ultrastructural level. METHODS: In an attempt to determine whether the presence of granules or inclusions marks a biologically distinct variety of ALL with peculiar clinical features, a prospective morphological review was undertaken of children entering AIEOP protocols for ALL in the period from 1985 to 1989. RESULTS: Of 531 cases examined, 16 (3%) were found to have greater than 1% granular bone marrow blasts, with 7 cases (1.3%) having greater than 10%. The presence of granules or inclusions was associated with the immunophenotype of "common" ALL. There was no clear association with FAB type L1 or L2 nor with particular clinical or hematological findings at presentation. Complete remission was achieved in all cases; one patient died of infection in remission at 3 months and 2 patients relapsed after 12 and 32 months, respectively, while the others are still in remission after a minimum follow-up of 24 months. CONCLUSIONS: In conclusion, granular morphology seems to have no prognostic importance in children ALL.

Acid Phosphatase↗
PubMedDate not supplied

Functional depletion of T cells by vincristine and methylprednisolone as an in vitro model for the prevention of graft versus host disease.

BACKGROUND AND METHODS. The outcome of mismatched bone marrow transplantation is still severely hampered by graft versus host disease (GVHD) and graft rejection. Procedures for the recognition and selective elimination of T cells are still unsatisfactory due to the increased incidence of graft failure and late rejection. Lymphocyte proliferation and generation of cytotoxic T cells (CTL) in response to allogeneic cells are considered good in vitro correlates of GVHD and have been used in the present study to asses the capacity of two drugs (vincristine, VCR, and methylprednisolone, MP) to affect the T cells involved in these reactions. RESULTS AND CONCLUSION. Treatment in vitro with VCR and MP has been shown to inhibit the functional capacity of peripheral blood lymphocytes to proliferate (mean reduction 95.8%) and to generate CTL in response to haploidentical stimulator cells. Responsiveness to antigens and mitogens was affected to a minor extent (mean reduction 40% and 65.5%, respectively), and the method allowed recovery of hemopoietic precursors. The results suggest that treatment of donor bone marrow with VCR and MP is worth studying as a new approach to the prevention of GVHD in haploidentical bone marrow transplantation.

Bone Marrow Cells↗
PubMedDate not supplied

[Italian study on the treatment of anaemia in chronic dialysis patients switched over to less frequent doses of darbepoetin from human recombinant erythropoietin (rHuEPO)].

BACKGROUND: Darbepoetin alpha is a novel erythropoiesis stimulating protein with unique properties as compared to recombinant human erythropoietin (rHuEPO), including a three-fold longer elimination half-life that allows for less frequent dosing. This study was aimed at testing the efficacy and safety of darbepoetin alpha in a large number of chronic dialysis patients switched from rHuEPO. METHODS: Nine hundred and fifty dialysis patients in stable treatment with rHuEPO were switched to darbepoetin alpha. Patients receiving rHuEPO 2 or 3 times weekly were switched to once weekly darbepoetin alpha and those receiving rHuEPO once weekly were switched to once every other week darbepoetin alpha. Patients received darbepoetin alpha by the same route of administration (SC or IV) as the one used for rHuEPO. The unit doses of darbepoetin alpha (10-150 microg) were titrated to maintain haemoglobin concentration within -1.0 and +1.5 g/dL of the individual mean baseline haemoglobin levels and between 10 and 13 g/dL for 24 weeks. RESULTS: The mean change in haemoglobin from baseline to the evaluation period (weeks 21-24) was statistically but not clinically significant [-0.10 g/dL (95% CI: -0.18, -0.02]. In general, the geometric mean weekly dose of study drug from screening/baseline to evaluation period remained substantially unmodified [(from 26.10 micro g/wk to 25.90 microg/wk; percentage change -0.40% (95% CI: -3.78, 3.10)]. Overall, darbepoetin alpha was well tolerated. CONCLUSIONS: The treatment of anaemia of a large dialysis patient population with unit dosing of darbepoetin alpha is effective and safe in maintaining target haemoglobin concentration at reduced dose frequency.

Anemia↗
PubMedDate not supplied

[Clinical dialysis: new problems and new prospects].

The main problem nephrologists have to face today is the very high patient morbidity and mortality. A number of traditional and non-traditional risk factors have a role; among these anaemia, hypertension, dislipidemia, abnormalities in calcium-phosphate metabolism, hyperhomocysteinemia and endothelial dysfunction. An important innovation in the field of hemodialysis has been the availability of high-permeable and high-flux membranes, characterized by a high biocompatibility and ultrafiltration coefficient. The development of automatic systems to control ultrafiltration has enabled the utilisation of these membranes in the clinical setting (high-flux hemodialysis, hemofiltration, hemodiafiltration). It is common opinion that high-flux membranes can positively influence cardiovascular instability, but this has not been confirmed by clinical trials. Although preliminary data indicated a favorable effect on the correction of anemia in patients treated with high-permeable membranes, randomized trials have not shown a significant effect. Better control of anemia could be possible by means of on-line treatments, given their higher removal of medium- and large molecules and reduced microbiological and pyrogenic contamination of the dialysate. A number of analyses showed a lower incidence of bone cysts and/or carpal tunnel syndrome in patients treated with high-flux membranes compared to low-flux ones. High-flux treatments could reduce morbidity and mortality in hemodialysis patients. However, despite its large sample size, the HEMO Study has not been capable of showing a statistically significant effect of higher dialysis dose and high-flux membranes on survival and morbidity. The MPO study has been expressively designed to do a prospective evaluation of the long-term effect of membrane permeability on clinical outcomes. These results are greatly awaited.

Amyloidosis↗
PubMedDate not supplied

[Italian Registry of Dialysis and Transplantation: 1996-2001 experience].

The Italian Registry of Dialysis and Transplantation (RIDT) was born in 1996 under the aegis of the Italian Society of Nephrology, and it is organized as a federation of regional registries. This study aimed to completely revise the epidemiological data collected during the first 5 yrs (1996-2001) of RIDT activity to evaluate the trends of the main epidemiological features. During this period, regional registries were not always able to assure complete and exhaustive information according to RIDT requirements, owing to different levels of organization and functioning. To avoid any possible error in data analysis, information inadequately assessed was refused. The incidence of end-stage renal disease (ESRD) patients on renal replacement therapy (RRT) in Italy has increased from 114 pmp in 1996 to 139 pmp in 2001, that means an increase of 3.5%/yr, corresponding to 5718 patients during 1996 and 8000 patients during 2001. Primary renal diseases (according to the EDTA) in incident ESRD patients are vascular and diabetic nephropathy. Main dialysis modality in incident patients was hemodialysis (HD) (85%), while peritoneal dialysis (PD) was only 15%; pre-emptive transplantation was a very unusual modality. The prevalence of ESRD patients at 31 December was 693 pmp in 1996 and 827 pmp in 2001; among dialysis patients, the corresponding rates were 575 pmp and 657 pmp, respectively. Consequently, the number of dialyzed patients increased, respectively, from 28892 to 37919. The prevalent dialysis modality was bicarbonate dialysis in 74% of cases, followed by hemodiafiltration (HDF) in 15%, continuous ambulatory peritoneal dialysis (CAPD) in 7% and APD in 3%. The gross mortality rate in dialyzed patients was stable during this period, at approximately 14%, the main causes of death being cardiovascular diseases and cachexia.

Adolescent↗
PubMedDate not supplied

[Epidemiology and demography of uremia: data from the Lombardy Dialysis and Transplantation Registry (RLDT)].

The Lombardy Registry of Dialysis and Transplantation (RLDT) since 1983 has collected data concerning patients affected by end-stage renal disease (ESRD) on renal replacement therapy (RRT) in Lombardy, a region of Northern Italy with 9 million inhabitants. This report illustrates the main features of ESRD patients on RRT: there were 6589 patients undergoing treatment at 31 December 2003, with a prevalence rate of 727 pmp. Patient numbers regularly increased by 4.5%/yr for the last 5 yrs. This phenomenon is probably due to the high incidence rate (172 pmp) of ESRD patients in Lombardy during these years related to a relatively stable mortality rate (15.2%). The increasing incidence is probably correlated to the population's characteristics: higher rates (189-223 pmp) were observed in certain provinces (Cremona, Lodi and Pavia) with a larger elderly population (people >65 yrs = >20%, people <65 yrs = <16%). Of dialysis modalities, 85% of prevalent patients were on hemodialysis (HD), 55% in hospital, and 30% in limited care units. The number of patients treated by peritoneal dialysis (PD) was stable during the last years, but showed a slow percentage decline (15% during 2003) since 1999. However, PD remains the first dialysis modality for 21.4% of new patients, with a wide variability among renal units. Regarding HD, highly efficient techniques (on-line hemodiafiltration (HDF)) represented 19.2%, with a significant increase (1.8%) compared to 2002. During 2003, the number of dialysis units in Lombardy was stable; there was only an increase in facility beds in limited care units in order to treat the increasing numbers of uremic patients.

Adult↗
PubMedDate not supplied

[Anemia treatment to reduce mortality risk and to improve quality of life in chronic uremic patients].

Survival of uremic patients on dialytic treatment is significantly worse compared with that of the general population, mainly because of cardiovascular disease (CVD) excess. Anemia, a frequent and relatively early complication of impaired renal function, can considerably worsen the outcome for these patients. Due to the induced alterations on cardiovascular structures, first, left ventricular hypertrophy, anemia is not only a condition significantly impairing quality of life, but also a serious threat for the long-term survival of patients undergoing dialysis. Several studies actually showed the existence of a clear inverse association between hemoglobin (Hb) levels and mortality or hospitalization rates in patients with renal failure. Although the benefits of a partial correction of Hb levels, even in terms of left ventricular hypertrophy regression, have been well documented, it remains unclear whether starting the treatment in a very early phase of the disease or achieving a complete normalization of Hb levels above the target values recommended by current guidelines can provide further advantages, at least in selected patient groups. However, ongoing clinical trials, particularly the CREATE and the ACORD, will be able to clarify better which anemia correction practices can ensure the best results both for quality of life and for cardiovascular status; and therefore, for the long-term survival of patients with renal disease.

Anemia↗