Tunneled hemodialysis central venous catheters prevalence and bloodstream infection rates in Northern Italy: A survey of the "East Lombardy Nephrological Network".

BACKGROUND: Tunneled central venous catheter (tCVCs) is a vascular access frequently employed in hemodialysis patients. Catheter-related bloodstream infections (CRBSI) are potentially life-threatening complications. METHODS: We performed a retrospective survey regarding tCVCs prevalence as well as the CRBSI incidence and management within five hospitals in the Brescia province belonging to the "East Lombardy Nephrological Network"; this study was based upon 18 queries regarding the years 2020 and 2021. RESULTS: The data collected refer to an overall hemodialysis population of 736 patients in 2020 and 745 patients in 2021. The prevalence of tCVCs was respectively 22.1% and 24.2% with the initial placement being performed with fluoroscopy support in 80% of the centers. CRBSI incidence was respectively 0.88 and 0.77 episodes per 1000 days of tCVC use. When the CRBI was caused by Staphylococcus Aureus (SA) or Pseudomonas, differently from the recommendation of the KDOQI guidelines, the removal or the substitution of the tCVC did not occur immediately at the time of the diagnosis of the infection but only when the specific antibiotic therapy failed. A nose swab aimed at identifying SA carriers was performed in 60% of centers. The policy regarding the referral to other specialists (infectious disease specialist and microbiologist) was heterogenous across the centers according to their specific logistics. CONCLUSIONS: This retrospective survey performed by the "East Lombardy Nephrological Network" within the Brescia province describes the prevalence of tCVCs use as well as the incidence and management of CRBSIs in the hemodialysis patients of this area. The clinical impact of the differences in terms of clinical approach detected compared to the KDOQI guidelines will need to be clarified ideally in prospective studies.

[Mid-dilution hemodiafiltration]. / Emodiafiltrazione ''mid-dilution''

On-line mid-dilution hemodiafiltration is a convective mixed therapy with improved middle-molecule removal compared to standard HDF. The main feature of the method is the exclusive design of two dialyzers in series (OLpur™), which allow combined postdilution and predilution HDF. Substitution fluid is infused after the first filter and before passage of the blood through the second filter. In this configuration, a postdilution HDF stage is followed by a predilution HDF stage. The method was subsequently optimized by reversing the two phases of reinfusion. The reverse configuration using the filter at a higher surface better preserves membrane permeability, allowing more efficient removal of medium-molecular-weight solutes. The technique can be performed with new-generation dialysis monitors equipped for on-line preparation of sterile infusion fluids. Several studies have confirmed the clinical benefits observed, including high phosphate and beta2-microglobulin removal and improved cardiovascular stability.

[Central venous catheter lock to prevent thrombosis and bacterial infection]. / Il rebus del ''lock'' del catetere venoso centrale per la prevenzione della trombosi e delle batteriemie da catetere.

The permanent central venous catheter (CVCp) for vascular access is increasingly common in patients on hemodialysis. The main problem related to CVCp is the biofilm, which leads to malfunction and an increased risk of infections. In recent years lock solutions for the CVCp have become popular. Heparin should be abandoned because it induces rapid biofilm development and exposes the patient to the risk of bleeding due to overspill of heparin into the bloodstream. Citrate solution (3.8%) is associated with the best risk/benefit ratio for CVC functioning but offers no advantages in terms of reducing infections. The use of hypertonic citrate (46.7%) or antimicrobic solutions (AML) should be reserved for patients with a high incidence of infection and in cases where it is not possible to replace the CVCp. AML should be used for short periods only because of the risk of the development of resistance. The results of ongoing trials will be needed to establish the usefulness of the solution with ethanol. In the correct management of the CVCp, whichever lock solution is used, continuing staff training and widespread application of hygiene measures is of the utmost importance.

The epidemiology of central venous catheter-related bloodstream infection in our renal units is changing.

Recent reports have shown an increase in the rate of Gram-negative bacteremia in several settings, including catheter-related bloodstream infections (CRBSI). To analyze if the epidemiology of CRBSI is also changing in hemodialysis patients, we revisited the etiology of CRBSIs in our renal unit over 8 years. During the observed periods, 149 episodes of CRBSIs were reported and the CRBSI incidence rate, ranged between 0.67 and 0.82 episodes/1000 tCVC days. Of these 149 episodes, 84 (56.3%) were due to Gram-positive bacteria, 62 (41.6%) to Gram-negative bacteria, and 3 (2.1%) to polymicrobial flora, no episodes of fungi were found. There was a trend, but not statistically significative, increase over time in the number of Gram-negative CRBSIs among the total CRBSIs, rising from 37.8% in the first period to 41.2% in the second period and to 44.3% in the last period, with a parallel decrease in the percentage of Gram-positive CRBSIs (from 59.5% to 56.9% and subsequently to 54.1%). Between Gram-negative, we reported an intensification of CRBSI due to Enterobacterales, particularly Escherichia coli. Among the Gram-negative, we have isolated germs rarely reported in the literature, such as Burkholderia cepacia, Pantoea agglomerans, and Rhizobium radiobacter. Regarding Gram-positive bacteria, a triplicate incidence of Staphylococcus aureus was reported with MRSA accounting for 42% in the third period. Among the Gram-positive bacteria, we reported two episodes of Kocuria kristinae and two of Bacillus spp.Our data demonstrated that the epidemiology of CRBSI in the same center, will change over time and Gram-negative strains are an increasing cause of CRBSI. The limitation of the present report is that statistical significance has not been reached, probably due to the limited number of CRBSI. New bacteria, both Gram-negative and Gram-positive, are emerging. Collaboration with the Microbiology Department appears essential to an appropriate diagnosis.

[Dialysis adequacy: Kt/V on its way out?]. / Adeguatezza dialitica: viale del tramonto del Kt/V?

The Kt/V index started being used in the 1980s to determine the adequacy of dialysis treatment. Based on a pharmacokinetic model and on urea as a marker of uremia, its use in clinical practice has allowed the development of new dialyzers that can provide high diffusive clearance but, above all, has established the knowledge that dialysis treatment should be tailored to the characteristics of the patient. After an initial period of uncertainty in which it was discussed which formula or model should be employed, there came a phase of excitement in which it was believed that the Kt/V index was synonymous with adequate dialysis. In the following years, several studies highlighted the limitations of Kt/V; in particular, the rescaling of Kt for the volume of distribution is a confounding factor because in patients on dialysis, sex and body mass index per se affect the mortality and morbidity. Doubts were also raised about urea as a marker of uremia. Whereas the measurement of Kt/V urea should not be abandoned, it should be viewed in the broader context of the definition of ''adequate dialysis'' as an index of the removal of small molecules, possibly together with Kt/V B2M as an index of the removal of middle molecules.

The middle-arm fistula as a valuable surgical approach in patients with end-stage renal disease.

BACKGROUND: American and European guidelines recommend the distal radial-cephalic fistula (dRCF) as the first and best hemodialysis access in patients with end-stage renal disease (ESRD). However, this kind of arteriovenous fistula (AVF) shows a limited primary unassisted patency and frequently needs surgical revisions or angiographic procedures, or both. When dRCF is not feasible, guidelines suggest a proximal brachiocephalic AVF. The middle-arm fistula (MAF), or autogenous forearm radial-median direct access, has been suggested as a possible alternative approach. This study evaluated MAF primary unassisted patency, the most frequent causes of MAF failure, and the possible related factors. METHODS: Data on patients with a MAF placed from January 1991 until June 2008 were retrospectively collected. The probability of MAF failure overall and by the main subgroups was estimated according to Kaplan-Meier with Greenwood standard error (SE). Comparison of failure among different subgroups was performed using the log rank test in univariate analyses. The Cox regression model was used to investigate factors that independently affected the overall hazard of failure and cause-specific hazard of thrombosis. RESULTS: At the end of follow-up, 14.0% of MAF failed (11.6% thrombosis, 1.7% stenosis, 0.7% failed maturation), and 44.2% of MAF were still working. Cumulative probability of MAF unassisted primary patency after 4 years from the creation was 79%. Univariate analyses highlighted that women (P = .019), underweight patients (P = .010), and MAF implantation after starting hemodialysis (P < .001) had a higher risk of MAF failure for any cause than men, normal and overweight patients, and MAF implanted before starting hemodialysis. Results of the Cox multivariate analysis for overall MAF failure confirmed that only MAF implantation before starting hemodialysis is a protective factor against any failure (P = .003), whereas female gender (P = .016) was associated with an increase of the thrombosis hazard ratio to 2.04 (95% confidence interval, 1.14-3.63). CONCLUSION: Our data demonstrate that MAF has a good unassisted primary patency and suggest that this kind of AVF could be a valuable alternative surgical approach when dRCF is not feasible in ESRD patients.

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. METHODS: An equation that estimates single-pool (sp) Kt/V(beta2-M) was derived from Leypoldt's formula, which calculates beta2-M dialyser clearance (K(beta2-M)) from the post/pre-dialysis beta2-M concentration (C(t)/C(0)) ratio and the weight loss/end-dialysis weight (Delta W/W) ratio. Our equation, spKt/V(beta2-M) = 6.12 Delta W/W [1 - ln(C(t)/C(0))/ln(1 + 6.12 Delta W/W)], was derived by assuming urea distribution volume (V(u)) as 49% of W and beta2-M volume (V(beta2-M)) as V(u)/3, in agreement with the average patient values in the HEMO Study. The spKt/V(beta2-M) values calculated with our equation (F) in 129 patients on 407 sessions of different high-flux treatments were compared with those calculated with the method applied in the HEMO Study (HM). Equilibrated beta2-M concentration (C(eq)) of the same sessions was also estimated with the equation for C(eq) by Tattersall, and equilibrated Kt/V (eKt/V(beta2-M)) was calculated by introducing Tattersall's equation into our simplified spKt/V(beta2-M) formula. RESULTS: Mean results of our spKt/V(beta2-M) equation (F) were very close to those of the HM method (1.48 +/- 0.38 vs 1.47 +/- 0.37). The difference was less than +/-0.1 in 95% of cases. A mean end-session beta2-M rebound of 44 +/- 14% was predicted, which caused a mean reduction in actual Kt/V(beta2-M) of ~27% (eKt/V(beta2-M) = 1.08 +/- 0.26). CONCLUSIONS: The method proposed to estimate spKt/V(beta2-M) and eKt/V(beta2-M) could become a simple tool to monitor the efficiency of high-flux HD and convective techniques and to evaluate the adequacy of treatments in terms of MM removal. Moreover, it might help to better understand the effects of different dialysis schedules. Validation on a larger dialysis population is required.

[Use of oral anticoagulants to prevent central venous catheter-related thrombosis in hemodialysis]. / Uso degli anticoagulanti orali per la prevenzione della trombosi dei cateteri venosi centrali per emodialisi.

Central venous catheters (CVCs) are fundamental in the management of hemodialysis. Despite major efforts to provide arteriovenous access, their use is increasing in dialysis units worldwide. The presence of a catheter inside a vein increases the risk of thrombosis, both within the catheter and in the vein. Thrombosis is a serious complication because it can lead to inefficient dialysis, alter the venous circulation, and facilitate infections. In this article, questions regarding anticoagulant treatment in dialysis patients with CVCs are explored and specific suggestions offered for clinical practice, based on the evidence available and the personal experience of the authors. Should CVC-induced thrombosis be treated? The duration, site and extension of the thrombotic complication should be assessed. If thrombosis is recent and symptomatic, heparin treatment followed by oral anticoagulant therapy is suggested. Is oral anticoagulant therapy useful for primary prevention of thrombosis, both within the CVC and the vein where the catheter is inserted? The available evidence favoring the use of oral anticoagulant therapy is not entirely convincing. At any rate, before such treatment is started the balance between the antithrombotic efficacy and the possible side effects should be carefully weighed. Is oral anticoagulant therapy useful for secondary prevention of CVC thrombosis? If a permanent CVC is in place and its position is correct and the blood flow < 250 mL/min, we recommend - before replacing the CVC - thrombolytic treatment followed by oral anticoagulants, aiming at an INR target between 2 and 3. Are the side effects of oral anticoagulant therapy an issue? The use of anticoagulants in renal failure carries an increased risk of complications, in particular bleeding and vascular calcifications, which could annul the advantages derived from reduced thrombotic events. Before starting oral anticoagulant therapy we suggest to carefully evaluate if there are potential overall benefits and to pay attention to concomitant antiplatelet therapy.

[Indications for vascular grafts as dialysis access; consensus from the Italian experience]. / Indicazioni all'uso delle protesi vascolari per l'accesso emodialitico: un'esperienza Italiana basata sul consenso.

In Italy, the use of arteriovenous grafts (AVGs) is limited (1-4%) due to different approaches to vascular access management compared to other countries, where guidelines that may not apply to the Italian setting have been produced. Therefore, the Vascular Access Study Group of the Italian Society of Nephrology produced this position paper, providing a list of 8 recommendations built upon current guidelines. The most controversial and innovative issues of the existing guidelines have been summed up in 12 different topics. We selected 60 Italian dialysis graft experts, nephrologists and vascular surgeons (PP1SIN Study Investigators). They were asked to express their approval or disapproval on each issue, thus creating a new method to share and exchange information. Almost all agreed on specific criteria for the choice of AVG over native arteriovenous fistulas (AVF) and tunneled venous catheters (tVC) and on the necessary conditions to implant them. They did not fully agree on the use of AVG in obese patients and patients at risk of developing ischemia, as an alternative to brachiobasilic fistula with vein transposition, and in case of a poorly organized setting. When AVF is feasible, it should be preferred. AVGs are indicated when superficial veins are unavailable or to repair an AVF (bridge graft). An AVG is an alternative to tVC if the expected patient survival is long enough to allow clinical benefits. The ultimate choice of the graft type is made by the physician in charge of the surgical intervention. Antithrombotic prophylaxis may be justified in some cases.

[Vascular access for hemodialysis: recommendations of the Vascular Access Study Group of the Italian Society of Nephrology]. / Gli accessi vascolari per emodialisi: le raccomandazioni del Gruppo di Studio della Società Italiana di Nefrologia.

The Vascular Access Study Group of the Italian Society of Nephrology has scheduled four national studies regarding the choice, implantation and use of vascular access. Study topics will include 1) utilization of vascular grafts for hemodialysis; 2) indications and use of venous catheters; 3) tunneled central venous catheter infection; 4) organization of the implantation and repair of vascular access. After examining the difficulties in implementing international guidelines on vascular access in Italy and the differences in practice patterns between our and other countries (where the most important studies were published), the Study Group set out to prepare four position papers based on discussion of controversial aspects of the international guidelines by nephrologists and surgeons experienced in the Italian practice. An innovative operative method for verifying the consensus on vascular access practice patterns was used. The final aim was to write a document addressed to vascular access operators (surgeons and nephrologists) based on the consensus of experts on controversial vascular-access- related issues. The project will include yearly updates of the documents.

High success rate in salvage of catheter-related bloodstream infections due to Staphylococcus aureus, on behalf of project group of Italian society of nephrology.

BACKGROUND: Catheter-related bloodstream infections caused by Staphylococcus aureus represent one of the most fearful infections in chronic haemodialysis patients with tunnelled central venous catheters. Current guidelines suggest prompt catheter removal in patients with positive blood cultures for S. aureus. This manoeuvre requires inserting a new catheter into the same vein or another one and is not without its risks. METHODS: A protocol based on early, prompt diagnosis and treatment has been utilized in our renal unit since 2012 in an attempt to salvage infected tunnelled central venous catheters. We prospectively observed 247 tunnelled central venous catheters in 173 haemodialysis patients involving 167,511 catheter days. RESULTS: We identified 113 catheter-related bloodstream infections (0.67 episodes per 1000 days/tunnelled central venous catheter). Forty were caused by S. aureus, including 19 by methicillin-resistant S. aureus (79% saved) and 21 by methicillin-sensitive S. aureus (90% saved), of which 34 (85%) were treated successfully. Eight recurrences occurred and six (75%) were successfully treated. A greater than 12 h time to blood culture positivity for S. aureus was a good prognostic index for successful therapy and tunnelled central venous catheter rescue. CONCLUSION: Our data lead us to believe that it is possible to successfully treat catheter-related bloodstream infection caused by S. aureus and to avoid removing the tunnelled central venous catheter in many more cases than what has been reported in the literature. On the third day, it is mandatory to decide whether to replace the tunnelled central venous catheter or to carry on with antibiotic therapy. Apyrexia and amelioration of laboratory parameters suggest continuing systemic and antibiotic lock therapy for no less than 4 weeks, otherwise, tunnelled central venous catheter removal is recommended.

[Cost analysis of haemodialysis catheter related bloodstream infection through the DRG system, "on behalf of Project Group of Vascular Access of Italian Society of Nephrology"].

Catheter related bloodstream infections (CRBSI) represent a complication that often requires hospitalization and the use of economic resources. In Italy, there is no literature that considers the costs of CRBSI for tunneled catheters (CVCt). The aim of this work is to evaluate the relative costs of CRBSI through the DRG system. From 2012 to 2017 we examined 2.257 hospital discharge forms, 358 of which relating to haemodialysis patients. Patients with CVCt (167), compared to FAVs (157), on average stay in hospital longer (10 vs. 8 days), entail higher costs (+8.5%) and higher admissions rate for infections (+114%). The incidence of CRBSI was 0.67 episodes per 1000 CVCt/days. CRBSI accounts for 23% of the cases of hospitalization of patients with CVCt and 5.2% of total hospitalization costs. Complicated CRBSI involve a 9% increase in average costs compared to simple ones, with patients staying in hospital three times longer. The cost of a CRBSI varies from €4,080 up to €14,800, with an average cost of €5,575. The costs calculated here are less than a third of that reported in American literature but this can be explained by the different reimbursement rates systems. The methodology of CRBSI costs through DRGs appears simple, and its main limit is the correct compilation of the discharge form. This is a reminder that discharge forms are an integral part of the medical record and can become important in recognizing the cost of the medical services provided.

Pilot study to assess increased dialysis efficiency in patients with limited blood flow rates due to vascular access problems.

In the last few years, the number of hemodialysis patients with inadequate blood flow (Qb) rates has increased due to vascular access problems. To avoid a clinical status of underdialysis, these patients need long-lasting dialysis sessions. However, other factors aimed to optimize the dialysis dose have to be considered. High-efficiency convective therapies, such as online hemodiafiltration (HDF), are claimed to be superior to high-flux hemodialysis (HF-HD) in improving the dialysis efficacy, but treatment efficacy is strongly related to blood flow rate and infusion volumes. Online mid-dilution (HDF-MD) with the Nephros OL-pure MD190 represents a new HDF concept to increase the removal of middle molecules. In a cross-over clinical trial, 8 patients, with Qb eff <300 mL/min, received either online HDF-MD or HF-HD; Qd was 700 mL/min, the time duration was 240 min, and the filtration volume in HDF-MD was 112+/-7 mL/min. No differences were found for Kt/V, urea, and creatinine clearances. Clearance of both small phosphate (P) large beta(2)-microglobulin (beta(2)m), and leptin (L) solutes was significantly greater for MD (P 217+/-32, beta(2)m 85.5+/-10, L 42.6+/-18 mL/min) than for HF-HD (P 178+/-32, beta(2)m 71.9+/-13, L 32.1+/-12 mL/min). The results of this study indicate that HDF remains the best means of providing increased removal of large-molecular weight solutes even in patients with vascular access problems.

A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy.

BACKGROUND: We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome. METHODS: To validate the hypothesis that the 2 treatments were equivalent, patients with biopsy-proven membranous nephropathy and nephrotic syndrome were randomly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months (group A) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year (group B). RESULTS: The primary outcome measure is cumulative number of remissions as a first event. Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event. After a median follow-up of 24 months (interquartile range, 15 to 25 months), there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d (interquartile range, 4.0 to 7.3 g/d) to 2.1 g/d (interquartile range, 0.4 to 3.8 g/d; P = 0.004) in group A and 6.0 g/d (interquartile range, 4.4 to 8.5 g/d) to 0.3 g/d (interquartile range, 0.2 to 1.9 g/d; P = 0.049) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy. CONCLUSION: Most nephrotic patients with membranous nephropathy responded to either treatment. Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone, without significant differences between these 2 therapies.

Factors associated with unsuccessful utilization and early failure of the arterio-venous fistula for hemodialysis.

BACKGROUND: Arteriovenous fistulae survive longer than grafts and catheters. However, their short term outcomes may not be as good. We sought to determine whether fistulae created in patients referred to a nephrologist less than 3 months before dialysis start show higher risk of unsuccessful use and early failure. METHODS: All patients receiving a new vascular access over a six-year period at three centres were enrolled. Logistic and Cox's regression techniques were used to model late referral on successful utilization for <6 consecutive HD-sessions and time to failure within the first month from access creation, adjusting for demographics, comorbidities and surgical strategies. RESULTS: Among the 535 subjects enrolled, 513 received a fistula. Without considering revisions, 119 fistulae (23.2%) were not successfully used and 61 (11.9%) failed early. Independent predictors of unsuccessful utilization were late referral (Odds Ratio 2.15 [95% Confidence Interval 1.23, 3.75]), vascular diseases (1.86 [1.16, 2.97]), absence of treated hypertension (2.07 [1.17, 3.68]), and heart failure limited to late referrals (10.74 [4, 28.82]). Late referral (Hazard Ratio 1.72 [1.05, 2.81]), absence of treated hypertension (1.80 [1.02, 3.18]) and heart failure (2.34 [1.34, 4.08]) also predicted primary early failure. CONCLUSIONS: Late patient referral and presence of cardiovascular diseases, particularly heart failure, are potentially modifiable risk factors for short-term outcomes improvement of hemodialysis fistulae.

Hemodialysis tunneled central venous catheters: five-year outcome analysis.

BACKGROUND: Tunneled central venous catheters (tCVCs) are considered inferior to arteriovenous fistulas (AVFs) and grafts in all nephrology guidelines. However, they are being increasingly used as hemodialysis vascular access. The purpose of this study was to document the natural history of tCVCs and determine the rate and type of catheter replacement. METHODS: This was a prospective study of 141 patients who underwent hemodialysis with tCVCs between January 2008 and December 2012. The patients used 154 tCVCs. Standard protocols about management of tCVCs, according to European Renal Best Practice, were well established. All catheters were inserted in the internal jugular vein. Criteria for catheter removal were persistent bloodstream infection, detection of an outbreak of catheter-related bloodstream (CRBS) infections, or catheter dysfunction. Event rates were calculated per 1,000 catheter days; tCVC cumulative survival was estimated by Kaplan-Meier analysis. RESULTS: Catheter replacement occurred in 15 patients (0.29 per 1,000 days); catheter dysfunction was the main cause of replacement (0.18 per 1,000 days), typically within 12 months of surgical insertion. A total of 53 CRBS events in 36 patients were identified (0.82 per 1,000 days); 17 organisms, most commonly Gram-positive pathogens, were isolated; 87% of CVC infections were treated by systemic antibiotics associated with lock therapy. tCVC cumulative survival was 91% at 1 year, 88% at 2 years and 85% at 4 years. CONCLUSIONS: Our data show a high survival rate of tCVCs in hemodialysis patients, with low incidence of catheter dysfunction and CRBS events. These data justify tCVC use for hemodialysis vascular access, also as first choice, especially in patients with exhausted peripheral access and limited life expectancy.

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.

Indications for vascular grafts as hemodialysis access: consensus from experience in Italy.

INTRODUCTION: In Italy, the use of arteriovenous grafts (AVG) is limited (1-5 %) due to different approaches to vascular access (VA) management as compared to other countries, where guidelines (which may not apply to the Italian setting) have been produced. Therefore, the Study Group (GdS) on VA of the Italian Society of Nephrology produced this position paper, providing a list of 8 recommendations built upon current guidelines. METHODS: The most controversial and innovative issues of existing guidelines have been summed up in 12 different statements. We selected 60 Italian dialysis graft experts, nephrologists and vascular surgeons (PP1SIN Study Investigators). They were asked to express their agreement/disagreement on each issue, thus creating a new method to share and exchange information. RESULTS: Most of them agreed (consensus > 90%) on specific criteria set to choose AVG over native AVF (nAVF) and tunnelled venous catheter (tVC) and on the necessary conditions to implant them. They did not fully agree on the use of AVG in obese patients, in patients at risk of developing ischemia, on the priority of AVG as an alternative to brachial-basilic fistula with vein transposition, and in case of a poorly organized setting regarding graft maintenance. Keeping in mind that the nAVF should be preferred whenever is feasible, AVGs are indicated when superficial veins are unavailable or to repair a nAVF (bridge graft). An AVG is an alternative to tVC if the expected patient survival is long enough to guarantee its clinical benefits.