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D Marcelli

Publications and source records attributed to D Marcelli.

At least 19 recordsLinked to original sources

Results from EuCliD (European Clinical Dialysis Database): impact of shifting treatment modality.

BACKGROUND: The use of biocompatible high-flux membranes is more efficient than low-flux membranes in controlling a number of hemodialysis-related diseases. The aim of this cooperative study was to evaluate the 6-month effect of a switch from low- to high-flux dialysers on patients treated in 39 Spanish dialysis centres. METHODS: The clinical data used in this analysis were prospectively collected by the EuCliD database, developed to monitor the quality of treatment delivered in a large network of European Dialysis Centres. Inclusion criteria for the study were the condition of end-stage renal disease (ESRD) on chronic hemodialysis and low-flux dialysis for at least six months before the switch to high-flux dialysis. Of 1,543 patients enrolled in the study between 2000 and 2001, 1,046 patients were considered for the analysis. 497 patients were excluded because they did not complete the follow-up. Outcome measures were the reduction of pre-dialysis beta-2 microglobulin, the improvement of anemia or reduction in rHu-EPO dose required to maintain best correction of anemia, reduction of inflammatory parameters (CRP), improvement in lipid profile (Total and HDL cholesterol, tryglycerides), maintenance of nutritional status. Albumin and "dry" (post-hemodialysis) body weight were both evaluated as nutritional indexes. RESULTS: During the six months of high-flux hemodialysis, there was a significant increase in hemoglobin (from 11.55 +/- 1.41 to 11.88 +/- 1.43 g/L; p < 0.001). Considering the temporarily untreated patients on a 0 U/week dose, erythropoietin remained stable (from 5,670 +/- 4,199 to 5,657 +/- 4,411 U/week). During the second part of the follow-up, the lipid profile significantly improved (Fig. 3). Total cholesterol and triglycerides decreased significantly (p < 0.001), while HDL cholesterol increased (p = 0.006). Calculated levels of LDL cholesterol also significantly decreased (p = 0.001). Dry body weight remained stable (64.7 +/- 11.9 vs. 64.7 +/- 12.0 kg) as well as in albumin levels (3.93 +/- 0.43 vs. 3.94 +/- 0.43 g/dL) between the two modalities of treatment. The level of beta2-microglobulin significantly decreased during high-flux dialysis (33.5 +/- 14.4 vs. 26.3 +/- 8.6 mg/dL, p < 0.001). CONCLUSION: All above mentioned results may have as a common denominator an improved blood purification from uremic toxins and a reduced level of chronic sub-clinical inflammation. All together, these results seem to confirm the superiority of high-flux dialysis in terms of clinical and physiological outcomes.

Aged↗

[Anemia management in haemodialysis. EuCliD database in Spain].

We present the results on Anaemia Management in Fresenius Medical Care Spain dialysis centres as reported by EuCliD (European Clinical Database), evaluating a population of 4,426 patients treated in Spain during the year 2001. To analyse the erythropoietin dose and the haemoglobin levels we divided the population in two groups according to the time with dialysis treatment: patients treated less than six months and patients between six months, and four years on therapy. We compared our results with the evidence based recommendations Guidelines: the European Best Practice Guidelines (EBPG) and the US National Kidney Foundation (NKF-K/DOQI). We also compared our results with those presented by the ESAM2 on 2,618 patients on dialysis in Spain carried out in the second half of the year 2000. We observed that 70% of the population reaches an haemoglobin value higher that 11 g/dl, with a mean erythropoietin (rHu-EPO) dose of 111.9 Ul/kg weight/week (n = 3,700; SD 74.9). However, for those patients on treatment for less than six months, the mean Haemoglobin only reaches 10.65 g/dl (n = 222; SD 1.4). The rHu-EPO was administrated subcutaneously in 70.2% of the patients. About the iron therapy, 86% of the patients received iron treatment and the administration route was intravenous in 93% of the population. The ferritin levels were below 100 micrograms/dl in 10% of the patients and 26.4% showed a transferrin saturation index (TSAT) below 20%. The erythropoieting resistance index (ERI), as rHu-EPO/haemoglobin, has been used to evaluate the response to rHu-Epo, according to different variables. It was observed that the following factors lead to a higher rHu-EPO resistance: intravenous rHu-EPO as administration route, the presence of hypoalbuminemia, increase of protein C reactive, Transferrin saturation below 20% and starting dialysis during the last six months.

Anemia↗

Diabetes mellitus in Tassin, France: remarkable transformation in incidence and outcome of ESRD in diabetes.

The incidence and prevalence of diabetes mellitus (DM) in the dialysis population in Europe, and more especially in France, have been lagging behind the impressive United States and Japanese rates. For a decade, things have been changing, and the incidence of DM in hemodialysis (HD) reached almost 40 in Tassin, France in 1999. The prevalence has followed the same trend but increased more slowly. The increase in incidence and prevalence is almost totally accounted for by type 2 DM explosive outbreak and development. The morbidity on dialysis (hypotensive episodes, hospitalization number, and duration) was significantly worse in diabetic patients (without difference between type 1 and 2) than in nondiabetic patients. The mortality rate was higher in diabetic patients than in nondiabetic patients (mean half-life 3 and 13 years, respectively), even after adjustment for age and comorbidity. The mortality rate was higher in type 2 than in type 1 (mean half-life 2.7 and 5.2 years, respectively), a difference which disappears when adjusting for age and comorbidity. Specific causes of death were different in diabetic and nondiabetic HD patients; in diabetics there was a six-fold higher cardiovascular (CV) and three-fold higher infectious mortality, but there was the same mortality from cancer. A strong difference was observed between type 1 and type 2 DM: in type 1 there was no increased infectious mortality and a moderately increased CV mortality compared with nondiabetic patients. Type 2 diabetic patients had a four-fold increased infectious and an eight-fold increased CV mortality. Altogether, the eruption of DM in our unit over the last decade has drastically increased the crude mortality, but the standardized mortality ratio using the USRDS mortality table remained unchanged, about 45 of expected mortality.

Adult↗

Comparison of mortality in ESRD patients on convective and diffusive extracorporeal treatments. The Registro Lombardo Dialisi E Trapianto.

BACKGROUND: The aim of this study was to evaluate the effect of convective [hemodiafiltration (HDF) or hemofiltration (HF)] versus diffusive treatments [hemodialysis (HD)] on end-stage renal disease (ESRD) patient mortality and dialysis-related amyloidosis (DRA) using data from the Lombardy Registry. METHODS: For this purpose, 6, 444 patients (aged 56.4 +/- 15.6 years, females 39.5%, diabetics 10. 6%) who started renal replacement therapy (RRT) on HD, HDF, or HF between 1983 and 1995 were considered. A total of 1,082 patients were treated with HDF or HF (first choice in the case of 188), with a median follow-up of 29.7 months. The median follow-up of the 6,298 patients on HD (first choice in the case of 6256) was 22.4 months. The time of survival on dialysis to carpal tunnel syndrome (CTS) surgery was evaluated as a hard marker of DRA morbidity. Survival was compared by means of the Cox proportional regression hazards model, using CTS surgery and all deaths as events for morbidity and mortality, respectively. Explanatory covariates were age, gender, and comorbidities; dialysis modality was tested as a time-dependent covariate. RESULTS: The relative risk (RR) for CTS surgery was significantly higher in older patients [RR = 1.04 per year of age on admission to RRT, 95% confidence interval (CI) 1.02 to 1.06; P = 0. 0001], in diabetics (RR = 2.63, 95% CI 1.30 to 5.31; P = 0.0007), and in patients with heart disease (RR = 5.36, 95% CI 2.27 to 12.68 P = 0.0001). Adjusting for age and diabetic status, the RR for CTS surgery was 42% lower in the patients treated with HDF or HF (RR = 0. 58, 95% CI 0.35 to 0.95, P = 0.03). The RR for mortality, adjusted for age, gender, and comorbidities, was 10% lower in patients treated with HDF or HF (RR = 0.90, 95% CI 0.76 to 1.06; P = NS). CONCLUSION: These results support the hypothesis that convective treatments are associated with a nonsignificant trend toward better survival and significantly delay the need for CTS surgery. An older age and the presence of diabetes and heart disease are other important risk factors for CTS surgery. These results could have an important clinical impact given the relevance of DRA in dialysis patient morbidity.

Adult↗

Opinions regarding outcome differences in European and US haemodialysis patients.

UNLABELLED: STUDY GOAL AND DESIGN: The aim of this evaluation was to understand why outcomes seem to be different in different parts of the world. In an attempt to look at this question from a point of view other than that necessarily adopted by epidemiological studies, we decided to explore the personal opinion of a selected group of American (US) and European (EU) experts by means of a simple questionnaire. A 13-item questionnaire was sent to 14 internationally recognized opinion leaders in the field of haemodialysis: all seven Europeans and five of the seven Americans responded. The answers to each question were stratified in order to highlight the key differences between the experts in the different continents. RESULTS: Ten of the 12 respondents (six EU and four US) said that dialysis outcomes are better in Europe; nine (six EU and three US) confirmed their opinion after taking patient characteristics into account. When asked to suggest reasons for this difference, the highest score was given to the quality of procedures and medical training with no differences between EU and US physicians. This was followed by three other factors that received the same overall score (financial issues, doctor bedside time and quality of pre-dialysis care), but it is interesting to note that the Europeans attributed considerably greater importance to bedside time than their US counterparts. CONCLUSION: It seems that the reported difference in dialysis outcomes between Europe and the US is a widely accepted fact. Although directed towards few respondents, our questionnaire does suggest some differences in the approach towards dialysis and end-stage renal disease patients.

Education, Medical↗

[Repeated accidents among adolescents. Anxiety traits, depressives and associated risk behavior].

PURPOSE OF THE STUDY: To look for and to assess the psychopathology of adolescents with repeated accidents. METHODS: A prospective study of a clinic group of adolescents from 12 to 18 years old with two or more accidents in the 18 months before. This group is compared to a matched control group. The clinical evaluation use Scan, Hamilton, C.E.S.D., M.A.D.R.S. and R.S.S. Zuckerman scales. RESULTS: The clinic group (boy: 83 p. 100) exhibited a significant improvement in severe Anxiety Disorders (83 p. 100) and Depressive Episode Disorder (25 p. 100). Improvement also occurred in Dysthymic disorders and Sensation Seeking. CONCLUSIONS: Repeated accidents occurred among adolescent with psychopathologic features which revealed some psychic difficulties needed an evaluation and an appropriated help.

Accidents↗

[Suicide and depression in adolescents].

In the adult, depression and suicide are strongly linked, and the effectiveness of the gesture is correlated with the depth of depression. In the adolescent, a correlation between suicide and depression was long denied because of the particularity of the signs of depression at that age. Presently, such a correlation is accepted, as shown by epidemiologic studies (retrospective and prospective) in suicidal or depressed adolescents. In the general population a relationship between the depressive state and the idea of suicide appears significant. From the psychopathological standpoint, a suicide attempt appears as a desire to attack one's own body, and depression as an impossibility to separate oneself from one's infant past, by which both differ from manifestations in the adult.

Adolescent↗

Ten years experience of renal replacement treatment in the elderly.

UNLABELLED: Elderly patients constitute an increasing segment of the end-stage renal disease population beginning renal replacement therapy (RRT) in the Western Countries. In this study we studied 2447 end-stage renal disease (ESRD) patients who started renal replacement treatment (RRT) in Lombardy between 1983 and 1992 at the age of 65 or older, with particular emphasis on survival and morbidity. In the last decade the number of elderly patients admitted yearly to RRT increased from 113 [102 per million population (pmp), 20% of all accepted patients] in 1983 to 375 (282 pmp, 42% of all accepted patients) in 1992. The most frequent primary nephropathies in 1992 were glomerulonephritis (21% vs 25% in 1983), vascular diseases (18% vs 13%) and diabetes (12% vs 7%). The use of acetate HD and IPD declined over the 10 years period from 49 to 11% and from 26 to 5%; that of bicarbonate HD and CAPD increased from 3 to 46% and from 26 to 32%. Hospitalization rate was related to age, sex, presence of systemic nephropathies or malignancy, but not to treatment modality. The main causes of death in 1992 were cardiovascular diseases (53 vs 42% in 1983) and cachexia (24 vs 18%). The survival rate of all elderly patients was 64, 39 and 13% at 2, 4 and 8 years. The covariates affecting patient survival (Cox model) were the presence at the start of RRT of systemic nephropathies (Hazard ratio 1.7), systemic atherosclerosis (1.6), other comorbidity conditions (1.38) and peritoneal dialysis (1.31). CONCLUSIONS: (1) The progressive increase in the number of patients admitted to RRT in the last decade is due to loose criteria of acceptance of elderly patients (increase in the acceptance rate of diabetics and patients with vascular disease), (2) patients' survival is affected by the presence of comorbid conditions at the start of RRT, (3) the worse survival rate in peritoneal dialysis could result from a hidden negative selection of patients, unmeasured by Cox analysis.

Adult↗

'Pulse oral' versus intravenous calcitriol therapy in chronic hemodialysis patients. A prospective and randomized study.

The aim of this prospective and randomized study was to compare the efficacy, side effects, and costs of 'pulse oral' versus intravenous calcitriol in the treatment of secondary hyperparathyroidism in hemodialysis (HD) patients. A total of 20 patients were randomized to receive over a 4-month period pulse orally administered calcitriol (pulse oral group; n = 10) or intravenous calcitriol (intravenous group; n = 10). All patients used standard dialysate calcium (1.75 mmol/l) throughout the study period. In accordance with the study design calcium dialysate concentrations were reduced when this was necessary to avoid hypercalcemic crises. The patients were stratified into two subgroups according to their initial serum PTH levels: patients with mild or moderate degree of hyperparathyroidism (17 patients) and patients with severe hyperparathyroidism (3 patients). Intravenous and pulse oral cacitriol did not significantly reduce serum PTH concentrations in patients with severe hyperparathyroidism (1,157 +/- 156 vs. 807 +/- 228 pg/ml [corrected], p = 0.09). Intermittent calcitriol, administered by intravenous or oral route, significantly reduced serum PTH levels (326 +/- 119 vs. 109 +/- 79 pg/ml [corrected], p = 0.0001) in patients with mild or moderate hyperparathyroidism. In patients with mild or moderate hyperparathyroidism, intravenous calcitriol significantly reduced PTH concentrations at the end of the 1st month, before the increase of serum ionized calcium levels, whereas 'pulse oral' calcitriol significantly suppressed parathyroid activity at the end of the 2nd month. Calcium dialysate concentration was reduced in 9 out of 10 (90%) patients of the pulse oral group and in all patients (10/10) of intravenous group. The incidence of hypercalcemic crises was 24% (39/160) in the pulse oral group and 14% (27/160) in the intravenous group. Analysis of costs showed that intravenous calcitriol was more expensive compared to pulse oral calcitriol. These data indicate that intermittent intensive calcitriol therapy, regardless of the route of administration, is effective in suppressing parathyroid activity in HD patients with mild or moderate hyperparathyroidism. In contrast, intermittent calcitriol therapy has a limited ability to achieve sustained serum PTH reductions in HD patients with severe hyperparathyroidism. Intravenous calcitriol was more expensive than pulse oral calcitriol, and we recommend the use of pulse oral calcitriol in HD patients with mild or moderate secondary hyperparathyroidism.

Administration, Oral↗

Factors affecting progression of renal insufficiency.

The aim of this study was to analyze the factors affecting chronic renal insufficiency (CRI) progression at diagnosis (markers of progression), their spontaneous or therapy-induced behavior, and their relationship to CRI progression during follow-up. The underlying disease is the 'determinant factor' of progression and although clinical trials usually report crude cumulative renal survival without taking into account concomitant risk factors, it is known that diabetic nephropathy, polycystic kidney disease, and glomerulonephritis are more progressive than nephroangiosclerosis and interstitial nephropathy. Among the 'effect modifiers,' the baseline level of renal function, hypertension, and proteinuria are the most important. The adverse synergistic effects of proteinuria and high blood pressure have been confirmed, and the importance of correcting hypertension (systemic and glomerular) and proteinuria for slowing disease progression has also been demonstrated. The potential adverse role of a high-protein intake, strongly suggested by experimental studies and the clinical data of uncontrolled trials, has been challenged by the data coming from large controlled trials. The role of lipids needs to be clarified by prospective randomized trials, but the effects of therapeutic interventions aimed at correcting lipid abnormalities seem very promising. The association between the DD genotype of the gene encoding the angiotensin-converting enzyme (ACE) and an increased risk of renal function loss is under evaluation with the aim of identifying the patients who may most benefit from ACE inhibition.

Biomarkers↗

Long-term effects of intravenous calcitriol therapy on the control of secondary hyperparathyroidism.

Although high-dose intravenous calcitriol has been shown to be effective in suppressing parathyroid hormone (PTH) secretion in dialysis patients with secondary hyperparathyroidism, an increasing number of patients is refractory to treatment. Only a few studies have evaluated the factors that can predict a favorable response to calcitriol, but contrasting results have been reported. This study was performed to evaluate the effect of high-dose intravenous calcitriol on parathyroid function and to investigate the factors that can predict a favorable response to treatment. Thirty-five dialysis patients were selected for intravenous calcitriol treatment (2 microg after dialysis for 12 months) because of increased PTH levels (>325 pg/mL). Before starting the treatment, the set point of calcium and the PTH-ionized calcium (ICa) curve was evaluated in each patient by inducing hypocalcemia and, 1 week later, hypercalcemia to maximally stimulate or inhibit PTH secretion. Parathyroid glands were assessed by high-resolution color Doppler ultrasonography. Throughout the study, calcium carbonate or acetate dosage was modified to maintain serum phosphate less than 5.5 mg/dL. Hypercalcemia was managed by reducing dialysate calcium to 5 mg/dL and, if necessary, calcitriol dose. The therapeutic goal was to reduce PTH levels below 260 pg/mL while maintaining normocalcemia. The patients who achieved the therapeutic goal were considered responders. Taking the data from the 35 patients together, we observed a significant decrease (P < 0.01) in alkaline phosphatase (from 252 +/- 106 IU/L to 194 +/- 81 IU/L) and PTH (from 578 +/- 231 pg/mL to 408 +/- 291 pg/mL), and a significant increase in serum ICa (from 5.1 +/- 0.2 mg/dL to 5.3 +/- 0.2 mg/dL; P < 0.001) after calcitriol therapy. PTH changes after therapy were not correlated to serum ICa changes, serum phosphate levels during treatment, and calcitriol dose. The response to therapy was heterogeneous because PTH levels markedly decreased over the treatment period in 18 responsive patients, whereas they increased or remained unchanged in 14 of 17 nonresponders. In three additional refractory patients, there was a decline in PTH of 20% to 35%, but this decline was associated with hypercalcemia. Pretreatment parathyroid gland size, serum ICa, PTH, maximal PTH induced by hypocalcemia, minimal PTH induced by hypercalcemia, the set point of ICa, and the ICa levels at which maximal PTH secretion and inhibition occurred were higher in the 17 refractory patients than in the 18 responsive patients. However, logistic regression analysis showed that among these parathyroid function parameters, the only significant predictors of a favorable response to calcitriol therapy were the parathyroid gland size and the set point of ICa. Throughout the study, serum phosphate and calcitriol dose were comparable in the two groups. In conclusion, the response to intravenous calcitriol therapy in dialysis patients with secondary hyperparathyroidism is heterogeneous, consisting of patients who are either responsive or refractory to treatment; refractoriness can be predicted by parathyroid volume and calcium set point.

Calcitriol↗