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Physical inactivity is considered a significant risk factor for mortality and morbidity among chronic hemodialysis (HD) patients. Therefore, physical exercise is recommended in the treatment of HD patients. Although the beneficial effects of physical exercise in HD patients are well-described in the literature, the underlying physiological mechanisms still need to be fully understood. Recently, microRNAs (miRNAs) have emerged as potential mediators of the therapeutic effects of physical exercise in healthy individuals. miRNAs are short, single-stranded, noncoding RNAs involved in gene expression regulation. Specifically, upon forming the RNA-induced silencing complex, miRNAs selectively bind to specific miRNAs within cells, reducing gene expression. miRNAs can be secreted by cells in an accessible form or enclosed within exosomes or extracellular vesicles. They can be detected in various body fluids, including serum (circulating miRNAs), facilitating the study of their diverse expression. Currently, there is no available data regarding the impact of physical exercise on the expression of miRNAs involved in osteogenic differentiation, a fundamental mechanism in the development of vascular calcification, for HD patients. Therefore, we have designed an observational and longitudinal case-control study to evaluate the expression of miR-9 and miR-30b in HD patients participating in a 3-month interdialytic physical exercise program. This paper aims to present the study protocol and review the expression of circulating miRNAs in HD patients and their modulation through physical exercise.

Fabry disease (FD) is a rare genetic disorder caused by a deficiency in the α-galactosidase A enzyme, which results in the globotriaosylceramide accumulation in many organs, including the kidneys. Nephropathy is a major FD complication that can progress to end-stage renal disease if not treated early. Although enzyme replacement therapy and chaperone therapy are effective, other treatments such as ACE inhibitors and angiotensin receptor blockers can also provide nephroprotective effects when renal damage is also established. Recently, SGLT2 inhibitors have been approved as innovative drugs for treating chronic kidney disease. Thus, we plan a multicenter observational prospective cohort study to assess the effect of Dapagliflozin, a SGLT2 inhibitor, in FD patients with chronic kidney disease (CKD) stages 1-3. The objectives are to evaluate the effect of Dapagliflozin primarily on albuminuria and secondarily on kidney disease progression and clinical FD stability. Thirdly, any association between SGT2i and cardiac pathology, exercise capacity, kidney and inflammatory biomarkers, quality of life, and psychosocial factors will also be evaluated. The inclusion criteria are age ≥ 18; CKD stages 1-3; and albuminuria despite stable treatment with ERT/Migalastat and ACEi/ARB. The exclusion criteria are immunosuppressive therapy, type 1 diabetes, eGFR < 30 mL/min/1.73 m 2 , and recurrent UTIs. Baseline, 12-month, and 24-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data. Additionally, an exercise capacity and psychosocial assessment will be performed. The study could provide new insights into using SGLT2 inhibitors for treating kidney manifestations in Fabry disease.

Although atherosclerotic renal artery stenosis (ARAS) is strictly associated with high cardiovascular risk and mortality, it often may remain unrecognized being clinically silent and frequently masked by co-morbidities especially in elderly patients with coexisting chronic kidney disease (CKD). The present observational study was conducted in elderly CKD-patients with atherosclerosis on other arterial beds. The aims were assessment of (1) ARAS prevalence; (2) best predictor(s) of ARAS, using duplex ultrasound; and (3) cardiovascular and renal outcomes at one-year follow-up. The cohort was represented by 607 consecutive in-patients. Inclusion criteria were age ≥65 years; CKD stages 2−5 not on dialysis; single or multiple atherosclerotic plaque on epiaortic vessels, abdominal aorta, aortic arch, coronary arteries, peripheral arteries that had been previously ascertained by one or more procedures. Duplex ultrasound was used to detect ARAS. Multiple regression analysis and ROS curve were performed to identify the predictors of ARAS. ARAS was found in 53 (44%) out of 120 patients who met the inclusion criteria. In univariate analysis, GFR (b = −0.021; p = 0.02); hemoglobin (b = −0.233; p = 0.02); BMI (b = 0.134; p = 0.036) and atherosclerosis of abdominal aorta and/or peripheral vessels (b = 1.025; p < 0.001) were associated with ARAS. In multivariable analysis, abdominal aorta and/or peripheral atherosclerosis was a significant (p = 0.002) predictor of ARAS. The area under the ROC curve was 0.655 (C.I. = 0.532−0.777; p = 0.019). ARAS is common in older CKD patients with extra-renal atherosclerosis, with the highest prevalence in those with aortic and peripheral atherosclerosis. ARAS may pass by unnoticed in everyday clinical practice.

To evaluate the impact of the Coronavirus Disease-19 (COVID-19) pandemic on the epidemiology of acute kidney injury (AKI) in hospitalized patients, we performed a retrospective cohort study comparing data of patients hospitalized from January 2016 to December 2019 (pre-COVID-19 period) and from January to December 2020 (COVID-19 period, including both severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative and positive patients). AKI was classified by evaluating the kinetics of creatinine levels. A total of 51,681 patients during the pre-COVID-19 period and 10,062 during the COVID-19 period (9026 SARS-CoV-2-negative and 1036 SARS-CoV-2-positive) were analyzed. Patients admitted in the COVID-19 period were significantly older, with a higher prevalence of males. In-hospital AKI incidence was 31.7% during the COVID-19 period (30.5% in SARS-CoV-2-negative patients and 42.2% in SARS-CoV-2-positive ones) as compared to 25.9% during the pre-COVID-19 period (p < 0.0001). In the multivariate analysis, AKI development was independently associated with both SARS-CoV-2 infection and admission period. Moreover, evaluating the pre-admission estimated glomerular filtration rate (eGFR) we found that during the COVID-19 period, there was an increase in AKI stage 2−3 incidence both in patients with pre-admission eGFR < 60 mL/min/1.73 m2 and in those with eGFR ≥ 60 mL/min/1.73 m2 (“de novo” AKI). Similarly, clinical outcomes evaluated as intensive care unit admission, length of hospital stay, and mortality were significantly worse in patients admitted in the COVID-19 period. Additionally, in this case, the mortality was independently correlated with the admission during the COVID-19 period and SARS-CoV-2 infection. In conclusion, we found that during the COVID-19 pandemic, in-hospital AKI epidemiology has changed, not only for patients affected by COVID-19. These modifications underline the necessity to rethink AKI management during health emergencies.

Ultrasound-guided percutaneous renal biopsy (PRB) has revolutionized the clinical practice of nephrology in the last decades. PRB remains an essential tool for the diagnosis, prognosis, and therapeutic management of several renal diseases and for the assessment of renal involvement in systemic diseases. In this study, we examine the different applications and provide a review of the current evidence on the periprocedural management of patients. PRB is recommended in patients with significant proteinuria, hematuria, acute kidney injury, unexpected worsening of renal function, and allograft dysfunction after excluding pre- and post-renal causes. A preliminary ultrasound examination is needed to assess the presence of anatomic anomalies of the kidney and to identify vessels that might be damaged by the needle during the procedure. Kidney biopsy is usually performed in the prone position on the lower pole of the left kidney, whereas in patients with obesity, the supine antero-lateral position is preferred. After preparing a sterile field and the injection of local anesthetics, an automatic spring-loaded biopsy gun is used under ultrasound guidance to obtain samples of renal parenchyma for histopathology. After the procedure, an ultrasound scan must be performed for the prompt identification of potential early bleeding complications. As 33% of complications occur after 8 h and 91% occur within 24 h, the ideal post-procedural observation time is 24 h. PRB is a safe procedure and should be considered a routine part of the clinical practice of nephrology.

Although kidney transplant can lead to psychiatric disorders, psychosocial syndromes and demoralization, a positive post-traumatic growth (PTG) can occur in kidney transplant recipients (KTRs). However, the PTG-Inventory (PTGI), a reliable tool to measure PTG is scarcely used to explore the effect of this stressful event in KTRs. Thus, the purpose of our study was to assess the level of PTG and its correlation with demoralization, physical and emotional symptoms or problems via network analysis in KTRs. Additionally, we aimed at exploring the association of PTG with psychiatric diagnoses, Diagnostic Criteria for Psychosomatic Research (DCPR) conditions, and medical variables. A total of 134 KTRs were tested using MINI International Neuropsychiatric Interview 6.0 (MINI 6.0), DCPR interview, PTGI, Edmonton Symptom Assessment System (ESAS), Canadian Problem Checklist (CPC) and Demoralization scale (DS-IT). PTGI was used to investigate the positive psychological experience of patients after KT. It consists of 21 items divided in five factors. Routine biochemistry, immunosuppressive agents, socio-demographic and clinical data were collected. A symptom network analysis was conducted among PTGI, ESAS and DS-IT. Mean score of PTGI total of sample was 52.81 ± 19.81 with higher scores in women (58.53 ± 21.57) than in men (50.04 ± 18.39) ( p < 0.05). PTGI-Relating to Others (16.50 ± 7.99) sub-score was markedly higher than other PTGI factor sub-scores. KTRs with DCPR-alexithymia or International Classification of Diseases, tenth revision (ICD-10) anxiety disorders diagnosis had lower PTGI total score and higher PTGI-Personal Strength sub-score, respectively ( p < 0.05). The network analysis identified two communities: PTGI and ESAS with DS-IT. DS-IT Disheartenment, DS-IT Hopelessness and PTGI Relating to Others were the most central items in the network. After 1000 bootstrap procedures, the Exploratory graph analysis revealed the presence of a median of two communities in the network in 97.5% of the bootstrap iterations. A more extensive use of PTGI should be encouraged to identify and enhance the positive psychological changes after KT.

Sedentariness of patients affected by end-stage kidney disease (ESKD) expose them to high risk of unfavorable clinical outcomes. Exercise training is effective in improving physical function, quality of life (QoL) and long-term outcomes. However, the existing barriers related to patients, programs and dialysis staff limit patient participation and call for new strategies. This pragmatic nonrandomized trial will test the impact on ESKD population of an intervention proposed by an exercise facilitator regularly present in a dialysis center. The patient will be free to choose among three-month walking and/or resistance low-intensity training programs: (a) guided physical activity increase; (b) home-based exercise; (c) in-hospital (pre/post dialysis) supervised exercise; (d) performance assessment only. The first phase will define feasibility and the characteristics and preference of responders. The second phase will evaluate safety and patients' adherence. Outcome measures will be collected at baseline, after three-month and at six-month follow-up. They will include: aerobic capacity, QoL, gait speed, strength, depression and long-term clinical outcomes (hospitalization and mortality). The trial was approved by the Area-Vasta Emilia-Romagna Centro Ethics Committee with approval number 48/2019. Written informed consent will be obtained from all participants. The results of the study will be presented in international congresses, published in peer-reviewed journals and communicated to the patient community. Registration details: Clinicaltrials.gov NCT04282616 [Registered:24/02/2020].

Demoralization is a commonly observed syndrome in medically ill patients. The risk of demoralization may increase in patients after a kidney transplant (KTRs) because of the stressful nature of renal transplantation, psychosocial challenges, and adjustment needs. No study is available on demoralization amongst KTRs. The purpose of our study was to evaluate the validity of the Italian version of the Demoralization Scale (DS-IT) and the prevalence of demoralization in KTRs. Also, we aimed at exploring the association of the DS-IT with International Classification of Diseases (ICD) psychiatric diagnoses, post-traumatic growth (PTG), psychological and physical symptoms, and daily-life problems. A total of 134 KTRs were administered the MINI International Neuropsychiatric Interview 6.0. and the Diagnostic Criteria for Psychosomatic Research-Demoralization (DCPR/D) Interview. The DS-IT, the Edmonton Symptom Assessment System (ESAS), the Canadian Problem Checklist (CPC), were used to measure demoralization, physical and psychological symptoms, and daily-life problems; also, positive psychological experience of kidney transplantation was assessed with the PTG Inventory. Routine biochemistry and sociodemographic data were collected. Exploratory factor analysis demonstrated a four-dimensional factor structure of the DS-IT, explaining 55% of the variance (loss of meaning and purpose, disheartenment, dysphoria, and sense of failure). DS-IT Cronbach alpha coefficients indicated good or acceptable level of internal consistency. The area under the Receiving Operating Characteristics (ROC) curve for DS-IT (against the DCPR/D interview as a gold standard) was 0.92. The DS-IT optimal cut-off points were ≥20 (sensitivity 0.87, specificity 0.82). By examining the level of demoralization, 14.2%, 46.3%, 24.6%, and 14.6% of our sample were classified as having no, low, moderate, and high demoralization, respectively, with differences according to the ICD psychiatric diagnoses ( p < 0.001). DS-IT Total and subscales scores were positively correlated with scores of ESAS symptoms and CPC score. A correlation between DS-IT loss of meaning and purpose subscale and PTGI appreciation of life subscale ( p < 0.05) was found. This study shows, for the first time, a satisfactory level of reliability of the DS-IT and a high prevalence of severe demoralization in KTRs.

An average prevalence of 35% for psychiatric comorbidity has been reported in kidney transplant recipients (KTRs) and an even higher prevalence of other psychosocial syndromes, as defined by the Diagnostic Criteria for Psychosomatic Research (DCPR), has also been found in this population. Consequently, an easy, simple, rapid psychiatric tool is needed to measure physical and psychological symptoms of distress in KTRs. Recently, the Edmonton Symptom Assessment System (ESAS), a pragmatic patient-centred symptom assessment tool, was validated in a single cohort of KTRs. The aims of this study were: to test the screening performances of ESAS for the International Classification of Diseases-10th Revision (ICD-10) psychiatric diagnoses in KTRs; to investigate the optimal cut-off points for ESAS physical, psychological and global subscales in detecting ICD-10 psychiatric diagnoses; and to compare ESAS scores among KTR with ICD-10 diagnosis and DCPR diagnosis. 134 KTRs were evaluated and administered the MINI International Neuropsychiatric Interview 6.0 and the DCPR Interview. The ESAS and Canadian Problem Checklist (CPC) were given as self-report instruments to be filled in and were used to examine the severity of physical and psychological symptoms and daily-life problems. The physical distress sub-score (ESAS-PHYS), psychological distress sub-score (ESAS-PSY) and global distress score (ESAS-TOT) were obtained by summing up scores of six physical symptoms, four psychological symptoms and all single ESAS symptoms, respectively. Routine biochemistry, immunosuppressive agents, socio-demographic and clinical data were collected. Receiving Operating Characteristic (ROC) analysis was used to examine the ability of the ESAS emotional distress (DT) item, ESAS-TOT, ESAS-PSY and ESAS-PHYS, to detect psychiatric cases defined by using MINI6.0. The area under the ROC curve for ESAS-TOT, ESAS-PHYS, ESAS-PSY and DT item were 0.85, 0.73, 0.89, and 0.77, respectively. The DT item, ESAS-TOT and ESAS-PSY optimal cut-off points were ≥4 (sensitivity 0.74, specificity 0.73), ≥20 (sensitivity 0.85, specificity 0.74) and ≥12 (sensitivity 0.85, specificity 0.80), respectively. No valid ESAS-PHYS cut-off was found (sensitivity <0.7, specificity <0.7). Thirty-nine (84.8%) KTRs with ICD-10 diagnosis did exceed both ESAS-TOT and ESAS-PSY cut-offs. Higher scores on the ESAS symptoms (except shortness of breath and lack of appetite) and on the CPC problems were found for ICD-10 cases and DCRP cases than for ICD-10 no-cases and DCPR no-cases. This study shows that ESAS had an optimal screening performance (84.8%) to identify ICD-10 psychiatric diagnosis, evaluated with MINI; furthermore, ESAS-TOT and ESAS-PSY cut-off points could provide a guide for clinical symptom management in KTRs.