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Patients on hemodialysis (HD) are vulnerable to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mount poor neutralizing antibody responses after two-dose vaccination. Although serological responses have been associated with reduced rates of reinfection, the relationship between cellular immunogenicity and protection has not been established. We report, for the first time, high incidence of reinfection in patients on HD who are vaccine naive (25%), which identifies that T cell responses do not predict protection against reinfection. Instead, patients on HD who went on to become reinfected had mounted highly variable and sometimes robust proliferative T cell responses to a broad array of SARS-CoV-2 peptide pools during the primary infection. The understanding that SARS-CoV-2–specific T cell responses are not predictive of protection against future infection will be a critical issue when measuring clinical efficacy of vaccination in these vulnerable cohorts, particularly when facing rapidly emerging variants of concern.

Background: Arteriovenous fistula (AVF) for hemodialysis integrates outward remodeling with vessel wall thickening in response to drastic hemodynamic changes. Aim of this study is to determine the role of Ki67, a well-established proliferative marker, related to AVF, and its relationship with time-dependent histological morphologic changes. Materials and methods: All patients were enrolled in 1 year and stratified in two groups: (A) pre-dialysis patients submitted to first AVF and (B) patients submitted to revision of AVF. Morphological changes: neo-angiogenesis (NAG), myointimal thickening (MIT), inflammatory infiltrate (IT), and aneurysmatic fistula degeneration (AD). The time of AVF creation was recorded. A biopsy of native vein in Group A and of arterialized vein in Group B was submitted to histological and immunohistochemical (IHC) analysis. IHC for Ki67 was automatically performed in all specimens. Ki67 immunoreactivity was assessed as the mean number of positive cells on several high-power fields, counted in the hot spots. Results: A total of 138 patients were enrolled, 69 (50.0%) Group A and 69 (50.0%) Group B. No NAG or MIT were found in Group A. Seven (10.1%) Group A veins showed a mild MIT. Analyzing the Group B, a moderate-to-severe MIT was present in 35 (50.7%), IT in 19 (27.5%), NAG in 37 (53.6%); AD was present in 10 (14.5%). All AVF of Group B with the exception of one (1.4%) showed a positivity for Ki67, with a mean of 12.31 ± 13.79 positive cells/hot spot (range 0–65). Ki67-immunoreactive cells had a subendothelial localization in 23 (33.3%) cases, a myointimal localization in SMC in 35 (50.7%) cases. The number of positive cells was significantly correlated with subendothelial localization of Ki67 ( p = 0.001) and with NA ( p = 0.001). Conclusions: Native veins do not contain cycling cells. In contrast, vascular cell proliferation starts immediately after AVF creation and persists independently of the time the fistula is set up. The amount of proliferating cells is significantly associated with MIT and subendothelial localization of Ki67-immunoreactive cells, thus suggesting a role of Ki-67 index in predicting AVF failure.

International audience; Background - Infective endocarditis (IE) is a common and serious complication in patients receiving chronic hemodialysis (HD). Objectives - This study sought to investigate whether there are significant differences in complications, cardiac surgery, relapses, and mortality between IE cases in HD and non-HD patients. Methods - Prospective cohort study (International Collaboration on Endocarditis databases, encompassing 7,715 IE episodes from 2000 to 2006 and from 2008 to 2012). Descriptive analysis of baseline characteristics, epidemiological and etiological features, complications and outcomes, and their comparison between HD and non-HD patients was performed. Risk factors for major embolic events, cardiac surgery, relapses, and in-hospital and 6-month mortality were investigated in HD-patients using multivariable logistic regression. Results - A total of 6,691 patients were included and 553 (8.3%) received HD. North America had a higher HD-IE proportion than the other regions. The predominant microorganism was Staphylococcus aureus (47.8%), followed by enterococci (15.4%). Both in-hospital and 6-month mortality were significantly higher in HD versus non-HD-IE patients (30.4% vs. 17% and 39.8% vs. 20.7%, respectively; p

Background and Objectives: Hemodialysis patients (HD) and kidney transplant recipients (KTRs) have been heavily impacted by COVID-19, showing increased risk of infection, worse clinical outcomes, and higher mortality rates than the general population. Although mass vaccination remains the most successful measure in counteracting the pandemic, less evidence is available on vaccine effectiveness in immunodepressed subjects previously infected and recovered from COVID-19. Materials and Methods: This study aimed at investigating the ability to develop an adequate antibody response after vaccination in a 2-dose series against SARS-CoV-2 in HD patients and KTR that was administered after laboratory and clinical recovery from COVID-19. Results: Comparing SARS-CoV-2 S1/S2 IgG levels measured before and after 2 doses of mRNA vaccine (BNT162b2 vaccine, Comirnaty, Pfizer–BioNTech or mRNA-1273 vaccine, Spikevax, Moderna), highly significant increases of antibody titers were observed. The antibody peak level was reached at 3 months following second dose administration, regardless of the underlying cause of immune depression and the time of pre-vaccine serology assessment after negativization. Conclusions: Our data indicate that HD patients and KTR exhibit a satisfying antibody response to a 2-dose series of mRNA vaccine, even in cases when infection-induced humoral immunity was poor or rapidly fading. Further studies are needed to evaluate the role of booster doses in conferring effective and durable protection in weak patient categories.

Background: Renal transplantation represents the therapeutic gold standard in patients with end stage renal disease (ESRD). Still the role of pre-transplant dialysis in affecting time to transplantation has yet to be determined. We wanted to verify whether the type of renal replacement therapy (hemodialysis vs. peritoneal dialysis) affects time to transplantation and to identify clinical features related to the longer time to transplantation. Methods: We performed a retrospective single-center observational study on patients who had received a transplant in the Bologna Transplant Unit from 1991 to 2019, described through the analysis of digital transplant list documents for sex, age, body mass index (BMI), blood group, comorbidities, underlying disease, serology, type of dialysis, time to transplantation, Panel Reactive Antibodies (PRA) max, number of preformed anti Human Leukocyte Antigens (HLA) antibodies. A p-value < 0.05 was considered statistically significant. Results: In the 1619 patients analyzed, we observed a significant difference in time to transplant, PRA max and Preformed Antibodies Number between patients who received Hemodialysis (HD) and Peritoneal dialysis (PD). Then we performed a multiple regression analysis with all the considered factors in order to identify features that support these differences. The clinical variables that independently and directly correlate with longer time to transplantation are PRA max (p < 0.0001), Antibodies number (p < 0.0001) and HD (p < 0.0001); though AB blood group (p < 0.0001), age (p < 0.003) and PD (p < 0.0001) inversely correlate with time to transplantation. Conclusions: In our work, PD population received renal transplants in a shorter period of time compared to HD and turned out to be less immunized. Considering immunization, the type of dialysis impacts both on PRA max and on anti HLA antibodies.

This study investigated the impact of the fourth COVID-19 pandemic wave on dialysis patients of Romagna territory, assessing the associations of vaccination status with infection risk, clinical severity and mortality. From November 2021 to February 2022, an epidemiological search was conducted on 829 patients under dialysis treatment for at least one month. The data were then analyzed with reference to the general population of the same area. A temporal comparison was also carried out with the previous pandemic waves (from March 2020 to October 2021). The epidemiological evolution over time in the dialysis population and in Romagna citizens replicated the global trend, as the peak of the fourth wave corresponded to the time of maximum diffusion of omicron variant (B.1.1.529). Of 771 prevalent dialysis patients at the beginning of the study, 109 (14.1%) contracted SARS-CoV-2 infection during the 4-month observation period. Vaccine adherence in the dialysis population of the reference area was above 95%. Compared to fully or partially vaccinated subjects, the unvaccinated ones showed a significantly higher proportion of infections (12.5% vs. 27.0% p = 0.0341), a more frequent need for hospitalization (22.2% vs. 50.0%) and a 3.3-fold increased mortality risk. These findings confirm the effectiveness of COVID-19 vaccines in keeping infectious risk under control and ameliorating clinical outcomes in immunocompromised patients.

Background: In recent years, physical exercise has been investigated for its potential as a therapeutic tool in patients with end-stage renal disease (ESRD) undergoing hemodialysis maintenance treatment (HD). It has been shown that regular practice of moderate-intensity exercise can improve certain aspects of immune function and exert anti-inflammatory effects, having been associated with low levels of pro-inflammatory cytokines and high levels of anti-inflammatory cytokines. Purpose: The aim of this review is to examine the studies carried out in this population that analyzed the effect of intradialytic exercise on the inflammatory state and evaluate which exercise modality is most effective. Methods: The search was carried out in the MEDLINE, CINAHL Web of Science and Cochrane Central Register of Controlled Trials databases from inception to June 2022. The PEDro scale was used to assess methodological quality, and the Cochrane Risk of Bias Tool and MINORS were used to evaluate the risk of bias. The quality of evidence was assessed with GRADE scale. The outcome measures were systemic inflammation biomarkers. Results: Mixed results were found in terms of improving inflammation biomarkers, such as CRP, IL-6 or TNFα, after exercise. Aerobic exercise seems to improve systemic inflammation when performed at medium intensity while resistance training produced better outcomes when performed at high intensity. However, some studies reported no differences after exercise and these results should be taken with caution. Conclusions: The low quality of the evidence suggests that aerobic and resistance exercise during HD treatment improves systemic inflammation biomarkers in patients with ESRD. In any case, interventions that increase physical activity in patients with ESRD are of vital importance as sedentary behaviors are associated with mortality. More studies are needed to affirm solid conclusions and to make intervention parameters, such as modality, dose, intensity or duration, sufficiently clear. Universidad Europea de Canarias 3.508 JCR (2021) Q2, 42/109 Health Care Siences & Services 0.757 SJR (2021) Q2, 753/2489 Medicine (miscellaneous) No data IDR 2021 UEC UEM

Background Patients undergoing hemodialysis are prone to psychiatric symptoms due to considerable changes in their individual, social and occupational life which can influence the course and prognosis of renal diseases. Objective The aim of the present study is to evaluate the prevalence of depression, anxiety, and suicidal ideation among patients with chronic kidney disease undergoing hemodialysis in Qazvin, Iran. Methods This descriptive cross- sectional study was performed on 120 patients with chronic kidney disease undergoing hemodialysis in Qazvin, Iran. Prior to study, their demographic and laboratory data were recorded. Dialysis adequacy was assessed using urea reduction ratio (URR) and KT/V formula. Data collection tools were Beck’s Depression Inventory, Beck’s Anxiety Inventory and Beck Scale for Suicidal Ideation. Collected data were analyzed using Pearson correlation test and t-test. Findings The mean level of depression in patients was 13.72 where 79 (65.8%) had depressive symptoms. The severity of symptoms was mild in 47 (39.2%), moderate in 21 (17.5%), and severe in 11 (9.2%). Moreover, the mean level of anxiety was 9.73 where 16 (13.3%) had anxiety symptoms. Of 120 patients, only 8 (6.7%) had suicidal ideation. There was a significant negative association between dialysis adequacy and the severity of depression, anxiety and suicidal ideation. Anxiety symptoms were more frequent among unemployed patients, and the increase in age was associated with the increase in suicidal ideations (P

Purpose of Review To review the results of studies of the effects of dialysis and kidney transplantation on the autonomic nervous system alterations that occur in chronic kidney disease. Recent Findings Vagal control of the heart mediated by arterial baroreceptors is altered early in the course of the renal disease. Sympathetic activation occurs, with increases in resting heart rate, venous plasma norepinephrine levels, muscle sympathetic nerve traffic, and other indirect indices of adrenergic drive. The magnitude of the changes reflects the clinical severity of the kidney disease. Both the sympathetic and parasympathetic alterations have a reflex origin, depending on the impairment in baroreflex and cardiopulmonary reflex control of the cardiovascular system. These alterations are partially reversed during acute hemodialysis, but the responses are variable depending on the specific type of dialytic treatment that is employed. Renal transplantation improves reflex cardiovascular control, resulting in sympathoinhibition following renal transplantation if the native kidneys are removed. Sympathoinhibitory effects have been also reported in renal failure patients after bilateral renal denervation. Summary Assessment of autonomic nervous system responses to dialysis and renal transplantation provides information of clinical interest, given the evidence that autonomic alterations are involved in the development and progression of cardiovascular complications, as well as in the prognosis of chronic kidney disease.

Background: Vascular calcification (VC) is a marker of cardiovascular (CV) disease and various methods allow for presence and extension assessment in different arterial districts. Nevertheless, it is currently unclear which one of these methods for VC evaluation best predict outcome and if this piece of information adds to the predictive value of traditional CV risk factors in patients receiving hemodialysis (HD). Methods: data of 184 of the 466 patients followed in the Independent study (NCT00710788) were post hoc examined to assess the association three concurrent measures of vascular calcification and all-cause survival. Specifically, coronary artery calcification (CAC) was determined by the Agatston and the volume score while abdominal aorta calcification was determined by plain X-ray of the lumbar spine (Kauppila score (KS)). Survival and regression models as well as metrics of risk recalculation were used to test the association of VC and outcome beyond the Framingham risk score. Results: Middle-age (62.6(15.8) years) men (51%) and women (49%) starting HD were analyzed. Over 36 (median 36, interquartile range: 8&ndash, 36) months of follow-up 69 patients expired. Each measure of VC (CAC or KS) predicted all-cause mortality independently factors commonly associated with all-cause survival (p &lt, 0.001). Far more importantly, each measurement of VC significantly improved risk prediction and patient reclassification (p &lt, 0.001) beyond traditional cardiovascular risk factors. Conclusions: Overall, presence and extension of VC, irrespective of the arterial site, predict risk of all-cause of death in patients starting hemodialysis. Of note, both CAC and KS increase risk stratification beyond traditional CV risk factors. However, future efforts are needed to assess whether a risk-based approach encompassing VC screening to guide HD patient management improves survival.

Background: Current guidelines recommend radiocephalic arteriovenous fistula (RCAVF) as a first choice access for hemodialysis, without specific indication for octogenarians .This study was undertaken to assess the efficacy of RCAVF in octogenarians compared with younger patients. Material and methods: All patients treated by RCAVF from January 2013 to December 2017 were included in a prospective database for a retrospective analysis. Patient demographics, comorbidities, and dialytic treatment data were collected prospectively and compared in patients Results: Within the study period, a total of 294 RCAVF were analyzed: 245 (83.3%) RCAVF were performed in Conclusions: Despite lower overall primary and primary assisted patency, RCAVF are associated with satisfactory results also in octogenarians if performed in absence of history of CVC. Under these circumstances RCAVF can be considered a first choice treatment.

Vascular calcification (VC) is a risk factor for cardiovascular events and mortality in chronic kidney disease (CKD). Several components influence the occurrence of VC, among which inflammation. A novel uremic toxin, lanthionine, was shown to increase intracellular calcium in endothelial cells and may have a role in VC. A group of CKD patients was selected and divided into patients with a glomerular filtration rate (GFR) of &lt, 45 mL/min/1.73 m2 and ≥45 mL/min/1.73 m2. Total Calcium Score (TCS), based on the Agatston score, was assessed as circulating lanthionine and a panel of different cytokines. A hemodialysis patient group was also considered. Lanthionine was elevated in CKD patients, and levels increased significantly in hemodialysis patients with respect to the two CKD groups, in addition, lanthionine increased along with the increase in TCS, starting from one up to three. Interleukin IL-6, IL-8, and Eotaxin were significantly increased in patients with GFR &lt, 45 mL/min/1.73 m2 with respect to those with GFR ≥ 45 mL/min/1.73 m2. IL-1b, IL-7, IL-8, IL-12, Eotaxin, and VEGF increased in calcified patients with respect to the non-calcified. IL-8 and Eotaxin were elevated both in the low GFR group and in the calcified group. We propose that lanthionine, but also IL-8 and Eotaxin, in particular, are a key feature of VC of CKD, with possible marker significance.

Background: It is estimated that chronic kidney disease (CKD) accounts globally for 5 to 10 million deaths annually, mainly due to cardiovascular (CV) diseases. Traditional as well as non-traditional CV risk factors such as vascular calcification are believed to drive this disproportionate risk burden. We aimed to investigate the association of coronary artery calcification (CAC) progression with all-cause mortality in patients new to hemodialysis (HD). Methods: Post hoc analysis of the Independent study (NCT00710788). At study inception and after 12 months of follow-up, 414 patients underwent computed tomography imaging for quantification of CAC via the Agatston methods. The square root method was used to assess CAC progression (CACP), and survival analyses were used to test its association with mortality. Results: Over a median follow-up of 36 months, 106 patients died from all causes. Expired patients were older, more likely to be diabetic or to have experienced an atherosclerotic CV event, and exhibited a significantly greater CAC burden (p = 0.002). Survival analyses confirmed an independent association of CAC burden (hazard ratio: 1.29, 95% confidence interval: 1.17–1.44) and CACP (HR: 5.16, 2.61–10.21) with all-cause mortality. CACP mitigated the risk associated with CAC burden (p = 0.002), and adjustment for calcium-free phosphate binder attenuated the strength of the link between CACP and mortality. Conclusions: CAC burden and CACP predict mortality in incident to dialysis patients. However, CACP reduced the risk associated with baseline CAC, and calcium-free phosphate binders attenuated the association of CACP and outcomes, suggesting that CACP modulation may improve survival in this population. Future endeavors are needed to confirm whether drugs or kidney transplantation may attenuate CACP and improve survival in HD patients.

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. Between July 2009 and February 2014, 140 participants were randomized to ramipril (1.25–10 mg/d) and 129 participants were allocated to non-RAS inhibition therapy, both titrated up to the maximally tolerated dose to achieve predefined target BP values. The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the single components of the primary end point, new-onset or recurrence of atrial fibrillation, hospitalizations for symptomatic fluid overload, thrombosis or stenosis of the arteriovenous fistula, and changes in cardiac mass index. All outcomes were evaluated up to 42 months after randomization. Results At comparable BP control, 23 participants on ramipril (16%) and 24 on non-RAS inhibitor therapy (19%) reached the primary composite end point (hazard ratio, 0.93; 95% confidence interval, 0.52 to 1.64; P=0.80). Ramipril reduced cardiac mass index at 1 year of follow-up (between-group difference in change from baseline: −16.3 g/m2; 95% confidence interval, −29.4 to −3.1), but did not significantly affect the other secondary outcomes. Hypotensive episodes were more frequent in participants allocated to ramipril than controls (41% versus 12%). Twenty participants on ramipril and nine controls developed cancer, including six gastrointestinal malignancies on ramipril (four were fatal), compared with none in controls. Conclusions Ramipril did not reduce the risk of major cardiovascular events in patients on maintenance hemodialysis. Clinical Trial registry name and registration number: ARCADIA, NCT00985322 and European Union Drug Regulating Authorities Clinical Trials Database number 2008–003529–17.

BACKGROUND: There is a high prevalence of atrial fibrillation (AF) in patients undergoing haemodialysis. Oral anticoagulant therapy with vitamin K antagonists (VKAs) is the only accepted treatment for the prevention of thromboembolism in haemodialysis patients with AF. However, in this population, the risk of bleeding is greatly increased. The aim of the study was to evaluate the ability of treatment quality indicators of VKA therapy to predict mortality and bleedings in a population of haemodialysis patients with AF. MATERIALS AND METHODS: A total of 129 patients were included in this cohort study. Deaths and bleeding events were recorded during a follow-up of 4 years. In all patients, International Normalized Ratio (INR) values were assessed at least once a month. Time in therapeutic range (TTR) and INR variability, as measured by the standard deviation of INR, were updated at each INR measurement. A Cox model with time-dependent co-variates and sandwich variance was applied. RESULTS: During follow-up, 71 patients died and 55 bleeding episodes occurred in 31 patients. INR variability was the only indicator associated with both mortality (hazard ratio [HR]=1.67, 95% confidence interval [CI] 1.12; 2.49, p=0.012) and bleeding (HR=2.85, 95% CI: 1.71; 4.75, p=0.0001). HR of mortality was higher in patients with INR >3 (HR=2.06, 95% CI: 1.09; 3.88, p=0.0259) than in subjects in therapeutic range 2

Background: In hemodialysis patients, a tunneled-cuffed permanent catheter is mandatory when the arteriovenous fistula is not feasible. The major risks of the use of tunneled-cuffed permanent catheter are bloodstream infections. The aim of this study is to analyze bloodstream infections from tunneled-cuffed permanent catheter in hemodialysis patients. Methods: An observational prospective study was carried out and 79 hemodialysis patients with tunneled-cuffed permanent catheter were enrolled. Patients were divided into those with bloodstream infections from tunneled-cuffed permanent catheter and those without. Their clinical and laboratory characteristics were compared. An original tunneled-cuffed permanent catheter lock therapy sequence was carried out combined with systemic antibiotic therapy. In case of antibiotic resistance, the tunneled-cuffed permanent catheter was removed. Results: The patients affected by bloodstream infections from tunneled-cuffed permanent catheter were 16/79 (20.3%). The bloodstream infection from tunneled-cuffed permanent catheter’s incidence rate was 0.52 per 1000 catheter days. Twenty-three bloodstream infections from tunneled-cuffed permanent catheter were found in 16/79 patients who used tunneled-cuffed permanent catheter. Staphylococcus aureus was the cause of bloodstream infection from tunneled-cuffed permanent catheter in 35% of the cases and Staphylococcus epidermidis in 30% of the cases. Risk factors were infection located in other organs and the presence of peripheral obstructive arterial disease. Conclusion: The enrolled cohort showed a reduced bloodstream infection from tunneled-cuffed permanent catheter incidence rate in comparison with the reference value (1 per 1000 catheter days). To reduce the number of bloodstream infections from tunneled-cuffed permanent catheter, hand hygiene and asepsis management of the tunneled-cuffed permanent catheter during the connection to the extracorporeal circuit and an original tunneled-cuffed permanent catheter lock therapy sequence seem to be the most efficient measures. Infections of other organs and the presence of peripheral obstructive arterial disease are the most important risk factors for bloodstream infections from tunneled-cuffed permanent catheter.

Immune disorders, involving both innate and adaptive response, are common in patients with end-stage renal disease under chronic hemodialysis. Endogenous and exogenous factors, such as uremic toxins and the extracorporeal treatment itself, alter the immune balance, leading to chronic inflammation and higher risk of cardiovascular events. Several studies have previously described the immune effects of chronic hemodialysis and the possibility to modulate inflammation through more biocompatible dialyzers and innovative techniques. On the other hand, very limited data are available on the possible immunological effects of a single hemodialysis treatment. In spite of the lacking information about the immunological reactivity related to a single session, there is evidence to indicate that mediators of innate and adaptive response, above all complement cascade and T cells, are implicated in immune system modulation during hemodialysis treatment. Expanding our understanding of these modulations represents a necessary basis to develop pro-tolerogenic strategies in specific conditions, like hemodialysis in septic patients or the last session prior to kidney transplant in candidates for receiving a graft.

Secondary hyperparathyroidism (SHPTH) is a major complication in patients on maintenance hemodialysis burdened with high cardiovascular risk. Hypertension is also a high prevalence complication contributing to an increase in the mortality rate in hemodialysis patients. A possible association between SHPTH and hypertension has been widely reported in the literature and several pathogenetic mechanisms have been described. There is evidence that the decrease of plasma iPTH levels are correlated with hypertension correction in hemodialysis patients undergoing parathyroidectomy and oral calcimimetics administration. We have observed a similar behaviour also in a patient on chronic hemodialysis treated with Etelcalcetide. Even if this is an isolated observation, it could stimulate future investigation, possibly in dedicated clinical trials.

Flaminia Coluzzi,1,2 Francesca Felicia Caputi,3 Domenico Billeci,4 Antonio Luigi Pastore,1,5 Sanzio Candeletti,3 Monica Rocco,2,6 Patrizia Romualdi3 1Department of Medical and Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Latina, Italy; 2Unit of Anesthesia, Intensive Care and Pain Medicine, Sant’Andrea University Hospital, Rome, Italy; 3Department of Pharmacy and Biotechnology, Alma Mater Studiorum University, Bologna, Italy; 4Division of Neurosurgery, Ca’Foncello Hospital, ASL Marca Trevigiana, University of Padova, Treviso, Italy; 5Unit of Urology, Sapienza c/o I.C.O.T, Polo Pontino, Latina, Italy; 6Department of Clinical and Surgical Translational Medicine, Sapienza University of Rome, Rome, ItalyCorrespondence: Flaminia ColuzziDepartment of Medical and Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, Polo Pontino 04100, Latina, ItalyTel +39 06 33775673Email flaminia.coluzzi@uniroma1.itAbstract: In patients suffering from moderate-to-severe chronic kidney disease (CKD) or end-stage renal disease (ESRD), subjected to hemodialysis (HD), pain is very common, but often underestimated. Opioids are still the mainstay of severe chronic pain management; however, their prescription in CKD and HD patients is still significantly low and pain is often under-treated. Altered pharmacokinetics and the lack of clinical trials on the use of opioids in patients with renal impairment increase physicians’ concerns in this specific population. This narrative review focused on the correct and safe use of opioids in patients with CKD and HD. Morphine and codeine are not recommended, because the accumulation of their metabolites may cause neurotoxic symptoms. Oxycodone and hydromorphone can be safely used, but adequate dosage adjustments are required in CKD. In dialyzed patients, these opioids should be considered as second-line agents and patients should be carefully monitored. According to different studies, buprenorphine and fentanyl could be considered first-line opioids in the management of pain in CKD; however, fentanyl is not appropriate in patients undergoing HD. Tapentadol does not need dosage adjustment in mild-to-moderate renal impairment conditions; however, no data are available on its use in ESRD. Opioid-related side effects may be exacerbated by common comorbidities in CKD patients. Opioid-induced constipation can be managed with peripherally-acting-μ-opioid-receptor-antagonists (PAMORA). Unlike the other PAMORA, naldemedine does not require any dose adjustment in CKD and HD patients. Accurate pain diagnosis, opioid titration and tailoring are mandatory to minimize the risks and to improve the outcome of the analgesic therapy.Keywords: opioids, chronic kidney disease, pain, hemodialysis, neuropathic pain, PAMORA

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Background and aims: Here we describe a dietary intervention for hyperphosphatemia in dialysis patients based on the partial replacement of meat and fish, which are one of the main sources of alimentary phosphorous, with egg white, a virtually phosphorous-free protein source. This intervention aims to reduce phosphorous intake without causing protein wasting. Patients and methods: As many as 23 hyperphosphatemic patients (15 male and 8 female, mean age 53.0 ± 10.0 years) on chronic standard 4 h, three times weekly, bicarbonate hemodialysis were enrolled in this open-label, randomized controlled trial. Patients in the intervention group were instructed to replace fish or meat with egg white in three meals a week for three months whereas diet was unchanged in the control group. Results: Serum phosphate concentrations were significantly lower in the intervention group than in controls after three (4.9 ± 1.0 vs 6.6 ± 0.8; p < 0.001) but not after one month of treatment. Phosphate concentrations decreased more from baseline in the intervention than in the control group both after one (−1,2 ± 1,1 vs 0,5 ± 1,1; p = 0.004) and after three (−1,7 ± 1,1 vs −0,6 ± 1,1; p < 0.001) months of follow-up. No change either in body weight or in body composition assessed with bioelectrical impedance analysis or in serum albumin concentration was observed in either group. Conclusion: The partial replacement of meat and fish with egg white induces a significant decrease in serum phosphate without causing protein malnutrition and could represent a useful instrument to control serum phosphate levels in hemodialysis patients. Clinicaltrials.gov identifier: NCT03236701. © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University

AIMS: The radio-cephalic arteriovenous fistula (RCAVF) is the first choice treatment in end-stage renal disease patients. In the last few years, the hemodialysis population has shown a high percentage of elderly patients (> 65 year old) with comorbidities, mainly vascular diseases, which may adversely affect their vascular access success. The aim of this study was to evaluate the effectiveness of a loup-assisted technique to create RCAVFs in over 65 patients. PATIENTS AND METHODS: 98 consecutive patients with renal failure were prospectively observed. The patient were divided in relation to their age (> 65 year old; < 65 year old). In both groups, a microsurgical distal RCAVF was created. Statistics included the prevalence of distal RCAVF created, the incidence of immediate failure, the primary and secondary patency rate at one year. RESULTS: Distal RCAVF was created in 82.60% of patients younger than 65 years and in 73.07% of patients older than 65 years, with no statistically significant difference. The incidence of immediate failure, the primary and secondary patency at one year were not statistically significant between the two groups. CONCLUSIONS: Distal RCAVF should be the first choice vascular access even in ESRD elderly patients. The loup-assisted microsurgical fistula creation, allows to perform distal RCAVF with success, even in patients older than 65 years old, achieving similar results to younger patients.

Objective: To investigate the relationship between the presence of ectopic calcification in the elongation of the styloid process (SP) and its possible clinical manifestation (Eagle syndrome) in a population of kidney-transplant patients previously treated with hemodialysis. Methods: Digital orthopantomography of 92 kidney-transplanted patients and 68 control subjects were analyzed to measure the length of SPs. Calcium, phosphate, alkaline phosphatase, and parathyroid hormone (PTH) blood levels were also available for comparison. Results: The mean length of SPs was significantly different between groups, as were phosphate and PTH values. Discussion: Renal transplant patients who have been treated with hemodialysis present elongated SPs, presumably due to alterations in phosphate balance and PTH levels. Thus, in cases of orofacial pain in patients with a history of altered bone metabolism, particularly when due to renal insufficiency, Eagle syndrome should be suspected as the main cause of symptoms.

Continuous management of dialysis patients exposes family caregivers to significant psychophysical risks. Having demonstrated the effectiveness of artificial intelligence in the care and assistance processes, it was hypothesized the implementation of a mobile app which would detect the distress of these Family Caregivers in order to activate support actions and adequate sustenance. In order to identify the Burnout risk factors of the Family Caregivers of dialysis patients, 31 items were selected, from the questionnaires recognized in the literature, and submitted to a sample of 713 subjects. The four components extracted through factor analysis identify critical aspects of the family caregiver’s experience. The neural network implemented on these four dimensions shows that overall they have an excellent ability to predict the stress state of the subjects (82%). From this study emerged the basic structure of a psychometric instrument suitable for the assessment of the stress of the family caregivers of patients undergoing dialysis treatment. This reagent can be administered through a mobile app and, using a deep learning algorithm, can report in real time the discomfort of the family caregivers.

The aim of our study was to identify patients' characteristics that predicted a higher chance of arteriovenous graft patency in patients undergoing Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access. The GHVG is a polytetrafluroethylene (PTFE) prosthesis with a nitinol-reinforced section (NRS) at the venous end. METHODS: All consecutive patients undergoing GHVG implantation for hemodialysis access at 10 tertiary referral centers between December 2013 and January 2018 were included in the study and compared with a control group of patients undergoing standard PTFE graft implantation. Selection of patients for hybrid graft implantation was based on the impossibility of autogenous vascular access creation. RESULTS: There were 145 patients included in the GHVG group and 218 in the PTFE group. In the GHVG and the PTFE groups, the mean age was 67 ± 13 years and 65 ± 13 years, and male patients totaled 52% and 46%, respectively. The technical success was 99%. The mean duration of the intervention was 100 minutes (median, 95 minutes; interquartile range, 80-120 minutes). The brachial-axillary configuration was used in the majority of cases (n = 78 [54%]). The 5-cm NRS length was prevalent (n = 108 [75%]). The median NRS oversize was 14% (interquartile range, 0%-21%). Mean follow-up was 13 months (range, 0-55 months). Seventy-one patients (49%) underwent at least one reintervention. Primary, assisted primary, and secondary patency estimates at 12 months were 44% ± 5%, 47% ± 5%, and 65% ± 4% for the GHVG group and 41% ± 4%, 53% ± 4%, and 75% ± 3% for the control group, respectively (P = NS). One-year survival was 90% ± 3%. On multivariable Cox regression analysis, hypotension (P < .001; hazard ratio [HR], 5.8; confidence interval [CI], 2.6-13) and diabetes (P = .024; HR, 1.9; CI, 1.1-3.2) were significant predictors of GHVG loss. A larger graft size was protective against GHVG loss (P = .042; HR, 0.73; CI, 0.54-0.99). The 10-cm-long graft showed a tendency toward improved patency but did not reach statistical significance (P = .074; HR, 0.48; CI, 0.21-1.07). CONCLUSIONS: Diabetes and hypotension were predictors of loss of hybrid arteriovenous access. Smaller diameters of NRS were more prone to thrombosis, whereas the 10-cm length seemed to perform better than the 5-cm one.

Background: Participation in music therapy is associated with improved psychological and physical indices among chronically ill patients. Listening to music during hemodialysis treatments positively affects patients’ hemodynamics, laboratory values, quality of life, and physical symptoms. The effect of live singing during hemodialysis treatments, however, has not previously been studied. Methods: A total of 24 participants with a diagnosis of end-stage kidney disease participated in the study. The vocalist was a musically trained dialysis nurse. Twelve of the patients listened to 15 min of live singing during 6 consecutive hemodialysis sessions, while the other 12 underwent standard hemodialysis. After a washout period of 2 days, the two groups were reversed. Results: Listening to live music was associated with improvements in systolic and diastolic blood pressure, better quality of sleep, fewer cramps, and reduced anxiety/depression, pain, and itching ( p < .05, all values). Conclusions: Listening to live music during hemodialysis is an effective and potentially low-cost therapy for the dialysis care team to employ during hemodialysis treatments.

Background Intradialytic hypotension (IDH) has a dramatic impact on the main outcomes of dialysis patients. Early warning of hemodynamic worsening during dialysis would enable preventive measures to be taken. Blood oxygen saturation (SO2) is used for hemodynamic monitoring in the critical care setting and may provide useful information about IDH onset. Aim To evaluate whether short- and medium-term variations in the SO2 signal (ST-SO2var, MT-SO2var,) during dialysis are a predictor of IDH. Methods In this 3-month observational cohort study, 51 hypotension-prone chronic hemodialysis (HD) patients, with vascular access by arteriovenous fistula (AVF) or central venous catheter (CVC), were enrolled. Continuous non-invasive blood SO2 was monitored (fc = 0.2 Hz) by an optical sensor on the arterial line of the extracorporeal circulation; blood pressure (every 30 min), symptoms and their time of appearance were noted. Predictive power of IDH was expressed by the area under curve (AUC) sensitivity and specificity based on intradialytic variations in SO2. Results A total of 1290 HD sessions were analyzed. Overall, off-line ST-SO2var analysis proved able to correctly predict IDH in 67 % of the sessions where IDH occurred. The best predictive performance was found in the presence of highly arterialized AVF (SO2 > 95 %) (75 % sensitivity; AUC 0.825; p

Introduction: An arteriovenous fistula (AVF) for placed for hemodialysis may be burdened by one particular complication-the formation of a venous aneurysm. It has been shown that matrix metalloproteinases (MMPs) and neutrophil gelatinase-associated lipocalin (NGAL) could represent markers of disease in both venous and arterial vessels. Materials and methods: This case study reports a rare case of enormous venous aneurysm-correlated MMP and NGAL levels in a woman with an AVF. Results: Significantly higher levels of plasma MMP-1, MMP-8, MMP-9, and NGAL were detected in this patient during aneurysmal evaluation before the surgery; these levels significantly decreased 1, 3 and 6 months after surgery. Conclusion: MMP and NGAL levels could represent a marker of aneurysmal disease, and their plasma evaluation could help physicians to stratify the risk of complications in patients with an AVF.

Increased blood pressure (BP) variability (BPV) is associated with high cardiovascular risk in hemodialysis. Studies on the effects of antihypertensive drugs on BPV in hemodialysis are scarce. This study examines the effects of nebivolol and irbesartan on short-term BPV in patients with intradialytic hypertension. This randomized-cross-over study included 38 patients (age: 60.4 ± 11.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase ≥ 10 mmHg at ≥4 over 6 consecutive sessions). After the baseline evaluation, participants were randomized to nebivolol 5 mg and subsequently irbesartan 150 mg, or vice versa, with a two-week wash-out period before initiation of the second drug. Patients underwent three respective 24 h-ABPM sessions starting before a midweek-session. We calculated the standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas. The post-hemodialysis and 24 h-SBP and DBP levels were significantly lower after treatment with both drugs. The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively). The diastolic-BPV indices decreased with nebivolol and increased with irbesartan, resulting in significant differences between the two drugs (SD: baseline 10.56 ± 2.50; nebivolol 9.75 ± 2.12; irbesartan 10.84 ± 1.98, between-drug p = 0.014; wSD: baseline 9.86 ± 2.12; nebivolol 9.34 ± 2.01; irbesartan 10.25 ± 2.01, between-drug p = 0.029). The diastolic-BPV during intradialytic and day-time periods was marginally lower with nebivolol than with irbesartan. During nighttime, the BPV indices were unchanged with either drug. The short-term BPV was reduced after nebivolol but not after irbesartan treatment in patients with intradialytic hypertension. These findings suggest that sympathetic-overdrive may be a major factor that affects BPV in intradialytic hypertension patients.

Sialadenitis by iodinated contrast medium (i.c.m) oriodine mumps (IM) is a rare and late benign manifestation that occurs independently of intravenous or endoarterial administration modality. If renal function is normal, i.c.m. does not reach salivary glands concentrations able to induce sialadenitis. However, a critical glomerular filtration reduction may lead to salivary ducts edema and glandular swelling after i.c.m. injection. We report a rare case report of IM in a patient on chronic hemodialysis.A 72-year-old woman affected by chronic kidney disease on chronic hemodialysis, underwent to endoscopic removal of a rectal cancer. For disease staging, a total body TC with i.c.m. was performed. The following morning, patient showed a soft and aching bilateral paroditidis swelling. Salivary glands ultrasound was diagnostic for sialadenitis. The patient was rapidly treated with betamethasone following by a 240 minutes post-dilution online hemodiafiltration session.Within the next 24h, a complete remission of IM was obtained.In our patient, a compensatory hyperactivity of the sodium / iodine symporter (NIS) on salivary gland cells may have played a crucial role in IM induction. An high efficiency hemodialysis session within the few following hours after i.c.m injection is a fundamental tool in patients on renal replacement treatment to prevent IM that is an epiphenomenon of i.c.m. accumulation.

Objective: The revascularization of critical limb ischemia (CLI) in hemodialysis (HD) patients features poor results in terms of patient survival and limb salvage. Recent predictive models in CLI revascularization did not specifically address HD patients. The aim of this study was to define risk factors for clinical success (CS) after revascularization of CLI in HD patients and to transform findings in a prognostic score. Methods: A retrospective study was conducted of prospectively gathered data, including consecutive HD patients treated for CLI from January 2004 to December 2012. Patients' demographics, comorbidities, CLI stage (Rutherford classification), tissue loss (Texas University Wound classification [TUWC]), and type of revascularization were assessed. End points were CS after revascularization (amputation-free and reintervention-free survival) and a prognostic score for CS based on significant risk factors (multivariable analysis). Results: In the study period, 131 patients (mean age, 70.2 ± 9.9 years; male, 76.3%) with a total of 180 limbs were treated. Endovascular (52.8%), surgical (28.9%), or hybrid (10.6%) revascularization was performed in 163 (90.6%) limbs in 117 patients. The mean (± standard deviation) follow-up was 20.8 ± 21.1 months. Considering revascularized patients, CS was 47.9%, 30.8%, and 17.8% at 6, 12, and 24 months, respectively. On multivariable analysis, age (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.01-1.05; P =.005), coronary artery disease (CAD; HR, 1.55; 95% CI, 1.04-2.32; P =.032), and TUWC stage D (HR, 1.80; 95% CI, 1.22-2.67; P =.003) were independent negative factors. Type of revascularization had no influence on CS. The score for predicting CS was 0.026 × age (years) + 0.441 × CAD + 0.59 × TUWC stage D. CAD and TUWC stage D were 1 in the presence of disease and 0 in the absence of disease. The score has a significant discrimination power of 75.5% (P =.036), with a best cutoff value of 2.07. Patients with a CS score 2.07 would have a high risk. There were 31 (26.5%) cases of low-risk score and 86 (73.5%) cases of high-risk score. Cases with low-risk score had a CS at 1 year of 51.6% compared with 23.3% in cases with high-risk score. Conclusions: CS after revascularization in HD patients remains poor independent of the type of revascularization. A prognostic model based on age, history of CAD, and severity of CLI (TUWC stage D lesion) can estimate an individual's chances of CS and may help in the decision-making process.

Background: We compared renal functional outcomes of robotic (RPN) and open partial nephrectomy (OPN) in patients with chronic kidney disease (CKD), a definite indication for nephron-sparing surgery. Methods: A multicenter retrospective analysis of OPN and RPN in patients with baseline ≥ CKD Stage III [estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2] was performed. Primary outcome was change in eGFR (ΔeGFR, mL/min/1.73 m2) between preoperative and last follow-up with respect to RENAL nephrometry score group [simple (4–6), intermediate (7–9), complex (10–12)]. Secondary outcomes included eGFR decline > 50%. Results: 728 patients (426 OPN, 302 RPN, mean follow-up 33.3 months) were analyzed. Similar RENAL score distribution (p = 0.148) was noted between groups. RPN had lower median estimated blood loss (p < 0.001), and hospital stay (3 vs. 5 days, p < 0.001). Median ischemia time (OPN 23.7 vs. RPN 21.5 min, p = 0.089), positive margin (p = 0.256), transfusion (p = 0.166), and 30-day complications (p = 0.208) were similar. For OPN vs. RPN, mean ΔeGFR demonstrated no significant difference for simple (0.5 vs. 0.3, p = 0.328), intermediate (2.1 vs. 2.1, p = 0.384), and complex (4.9 vs. 6.1, p = 0.108). Cox regression analysis demonstrated that decreasing preoperative eGFR (OR 1.10, p = 0.001) and complex RENAL score (OR 5.61, p = 0.03) were independent predictors for eGFR decline > 50%. Kaplan–Meier analysis demonstrated 5-year freedom from eGFR decline > 50% of 88.6% for OPN and 88.3% for RPN (p = 0.724). Conclusions: RPN and OPN demonstrated similar renal functional outcomes when stratified by tumor complexity group. Increasing tumor age and tumor complexity were primary drivers associated with functional decline. RPN provides similar renal functional outcomes to OPN in appropriately selected patients.

none 11 no Background: Sodium prescription in patients with intradialytic hypotension remains a challenge for the attending nephrologist, as it increases dialysate conductivity in hypotension-prone patients, thereby adding to dietary sodium levels. Methods: New sodium prescription strategies are now available, including the use of a mathematical model to compute the sodium mass to be removed during dialysis as a physiological controller. Results: This review describes the sodium load of patients with end-stage renal disease on chronic hemodialysis (HD) and discusses 2 strategies to remove excess sodium in patients prone to intradialytic hypotension, namely, Profiled HD and the hemodiafiltration Aequilibrium System. Conclusion: The Profiled HD and Aequilibrium System trial both proved effective in counteracting intradialytic hypotension. mixed Donati, Gabriele; Ursino, Mauro; Spazzoli, Alessandra; Natali, Nicolã²; Schillaci, Roberto; Conte, Diletta; Angeletti, Andrea; Croci Chiocchini, Anna Laura; Capelli, Irene; Baraldi, Olga; La Manna, Gaetano Donati, Gabriele; Ursino, Mauro; Spazzoli, Alessandra; Natali, Nicolã²; Schillaci, Roberto; Conte, Diletta; Angeletti, Andrea; Croci Chiocchini, Anna Laura; Capelli, Irene; Baraldi, Olga; La Manna, Gaetano

During hemodialysis (HD), blood is circulated through an extracorporeal tubing system (bloodline) made of medical-grade polymeric material. Sensors of various types that do not come into contact with blood (optical, electromagnetic, etc.) are applied directly across the bloodline for clinical purposes and for therapy customization. Thus, a detailed knowledge of the bloodline's physical properties is useful for the development of next-generation HD sensors. In this work, we performed a novel comparative analysis of the materials used by the manufacturers of the bloodlines. We focused on signals and characterization techniques matching those of the abovementioned sensors; consequently, this is an application-specific study of the optical and electrical characterization of bloodline material. Such properties are analyzed and compared for bloodlines from seven different manufacturers by optical absorbance spectroscopy and electrical impedance spectroscopy (EIS). Absorbance spectrum measurements are carried out in the VIS-NIR range. Absorbance spectra are pre-processed and data from both types of analyses are normalized with respect to sample thickness. Optical analysis shows that all bloodlines except one have similarly shaped spectra with slight quantitative differences. In all optical spectra, we find a decreasing trend of specific absorption from 0.14 mm??1 at 400 nm to 0.06 mm-1 at 1000 nm, with an absorption peak at 915 nm. In one case, a large absorption peak centered at ≃600 nm is found. Electrical analysis shows that all bloodlines have the electrical properties of a constant-phase element (CPE), with statistically significant differences in parameters' values. Estimation of electrical CPE parameters for all bloodline returns a range of 0.942-0.957 for parameter n and a range of 12.41-16.64 for parameter Q0'. In conclusion, we find that, although some statistically significant differences are present, bloodlines from a representative group of manufacturers share similar electrical and optical properties. Therefore, contactless sensing devices developed for HD will work on different bloodlines if a simple recalibration is performed.

In 2013, the Italian Society of Nephrology joined forces with Nephrocare-Italy to create a clinical research cohort of patients on file in the data-rich clinical management system (EUCLID) of this organization for the performance of observational studies in the hemodialysis (HD) population. To see whether patients in EUCLID are representative of the HD population in Italy, we set out to compare the whole EUCLID population with patients included in the regional HD registries in Emilia-Romagna (Northern Italy) and in Calabria (Southern Italy), the sole regions in Italy which have systematically collected an enlarged clinical data set allowing comparison with the data-rich EUCLID system. An analysis of prevalent and incident patients in 2010 and 2011 showed that EUCLID patients had a lower prevalence of coronary heart disease, peripheral vascular disease, heart failure, valvular heart disease, liver disease, peptic ulcer and other comorbidities and risk factors and a higher fractional urea clearance (Kt/V) than those in the Emilia Romagna and Calabria registries. Accordingly, survival analysis showed a lower mortality risk in the EUCLID 2010 and 2011 cohorts than in the combined two regional registries in the corresponding years: for 2010, hazard ratio (HR) EUCLID vs. Regional registries: 0.80 [95% confidence interval: 0.71–0.90]; for 2011, HR: 0.76 [0.65–0.90]. However, this difference was nullified by statistical adjustment for the difference in comorbidities and risk factors, indicating that the longer survival in the EUCLID database was attributable to the lower risk profile of patients included in that database. This preliminary analysis sets the stage for future observational studies and indicates that appropriate adjustment for difference in comorbidities and risk factors is needed to generalize to the Italian HD population analyses based on the data-rich EUCLID database.

Background/Aims: Vascular calcifications (VCs) and fractures are major complications of chronic kidney disease. Hemodialysis patients have a high prevalence of atrial fibrillation (AF) and an increased risk of thromboembolism, which should be prevented with warfarin, a drug potentially causing increased risk of VCs and fractures. Aim of this study is evaluating, in hemodialysis patients with and without AF, the prevalence of VCs and fractures, as well as identifying the associated risk factors. Methods: A total of 314 hemodialysis patients were recruited, 101 with documented AF and 213 without AF. Comorbidities, chronic kidney disease mineral and bone disorder blood tests and therapies were collected. Vertebral quantitative morphometry was carried out centrally for the detection of fractures, defined as vertebral body reduction by ≥20 %. In the same radiograph, the length of aortic calcification was also measured. Logistic regression models were applied for evaluating the independent predictors of presence of VCs and vertebral fractures. Results: In our population VCs were very common (>85 %). Severe VCs (>10 cm) were more common in patients with AF (76 %) than in patients without (33 %). Vertebral fractures were present in 54 % of patients. Multivariable analysis showed that AF (OR 5.41, 95 % CI 2.30–12.73) and 25(OH) vitamin D

Background and Aims Parathyroid hormone (PTH) measurements in hemodialysis (HD) patients are routinely performed every 3 to 6 months of therapy, which are adjusted in accordance with PTH. However, recent evidences show very high PTH biological variability. The aim of our study was to evaluate the role of serum β-crosslap (CTX), a validated marker of bone resorption, as indicator of PTH maintenance at different time intervals. Methods Forty-six HD patients fulfilled the inclusion criteria (HD age of more than 21 months and 7 PTH measurements for the last 21 months) for this retrospective cohort study and were enrolled. Data of the backward quarter PTH values for the last 21 months were collected from clinical records, and a single CTX was measured. To evaluate the relationship between CTX value and the maintenance of PTH in the short-term and long-term, 7 time intervals (3, 6, 9, 12, 15, 18, and 21 months) were stated and the mean value of PTH was measured within each interval and calculated for every patient. Results We found the following: (1) positive correlation between mean PTH in each time interval and β-crosslaps with a progressive increase of the correlation coefficient (highest value for the 12- and 21-month intervals); (2) significant differences between tertiles of β-crosslaps at 6-, 9-, 12-, 15-, 18-, and 21-month intervals, with a progressively growing value of the test coefficient; and (3) after the computation of receiver operating characteristic curves, β-crosslaps showed to significantly estimate threshold PTH values with the highest areas under the curves (AUCs; AUC, 0.763; 95% confidence interval, 0.625–0.901 for 300 pg/mL of PTH) and best value of both sensitivity and specificity at the 12-month time interval (82% and 72% for 300 pg/mL of PTH). Conclusions In HD patients, β-crosslaps have a potential ability to best estimate backward PTH into 12 months of interval.