Protected: Long-term efficacy and safety of etelcalcetide in hemodialysis patients with severe secondary hyperparathyroidism

Abstract

Introduction: Etelcalcetide has proven effective and well tolerated in the treatment of secondary hyperparathyroidism (IPS) in patients on hemodialysis (HD). Since long-term studies are scarce, we assessed the efficacy and safety of etelcalcetide in the treatment of severe IPS in a group of HD patients over a 12-month period. Patients and Methods: We selected 24 HD patients with PTH levels > 500 pg/mL (range 502-2148 pg/mL), despite following a therapy with cinacalcet and/or vitamin D analogues. The initial dosage of etelcalcetide was 7.5 mg/week, then it was adjusted based on the trend of the levels of the total albumin-corrected serum calcium (CaALb_c) and PTH. Treatment was temporarily suspended if CaALb_c levels were <7.5 mg/dL or if hypocalcemia was symptomatic. CaALb_c, phosphorus, PTH and total alkaline phosphatase (t-ALP) were measured monthly. The main endpoint was the decrease in PTH levels >30% compared to baseline values. Results: At F-U, the reduction in PTH levels was > 30% in 83% of our patients. PTH levels decreased from 1169 ± 438 to 452±241 pg/mL at F-U (P <0.001). The percentage of reduction in PTH levels at F-U was -56 ± 25%. CaALb_c and phosphate levels decreased from 9.8 ± 0.4 mg/dL to 9.0 ± 0.6 mg/dL (P <0.001), and from 6.1 ± 1.3 mg/dL to 4.9 ± 1.3 mg/dL (P <0.01), respectively. The main side effect was hypocalcaemia, but never so severe as to require the interruption of treatment. Hypocalcemia was more pronounced in patients with higher basal levels of PTH and t-ALP. During the study, the percentage of patients treated with calcium carbonate increased from 33% to 54% and that of patients treated with paricalcitol from 33% to 79%. At F-U the average weekly dosage of etelcalcetide was 21.0 ± 9.5 mg (range 7.5-37.5 mg/week). Conclusions: The treatment of severe IPS with etelcalcetide has been proved effective and safe in the long term. Hypocalcaemia, the most frequent side effect, was more evident in patients with the most severe forms of IPS and was probably due to a reduction in bone turnover rather than to the direct effect of etelcalcetide.

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Protected: Spondylodiscitis in hemodialysis patients: a new emerging disease? Data from an Italian Center

Abstract

Hemodialysis (HD) patients are at high risk for infectious complications such as spondylodiscitis. The aim of this retrospective study was to evaluate the cases of infective spondylodiscitis occurred between May 2005 and October 2019 among HD patients at our center.

In 14 years, there were 9 cases (mean age 69±12 years). The main comorbidities found were diabetes mellitus (55.6% of patients), hypertension (55.6%), bone diseases (22.2%), cancer (11.1%) and rheumatoid arthritis treated with steroids (11.1%). The clinical onset included back pain (100% of cases), fever (55.6%), neurological deficits (33.4%), leukocytosis (55.6%) and elevated CRP level (88.9%).

Most cases were diagnosed by magnetic resonance imaging (66.7%) with more frequent involvement of lumbar region (77.8%). Blood cultures were positive in five patients (mostly for S. aureus); three of them used catheters as vascular access and, in two cases, their removal was necessary. The mean time interval between the onset of symptoms and the diagnosis was 34±42 days.

All patients received antibiotic treatment for a mean duration of 6 weeks; most cases were initially treated with vancomycin or teicoplanin plus ciprofloxacin. Most patients (77.8%) recovered after a mean of 3.5 months; one patient had a relapse after 2 years and one patient had long-term neurologic sequelae.

La spondilodiscite infettiva nella MH deve essere sospettata in presenza di mal di schiena, anche in assenza di febbre o fattori di rischio tradizionali. Una diagnosi precoce potrebbe migliorare il risultato. Un attento monitoraggio dell’accesso vascolare, procedure di disinfezione e tecniche asettiche sono importanti per evitare questa complicanza.

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Protected: SARS-CoV-2 (COVID-19): recommendations on nursing care for dialyzed and transplanted patient

Abstract

Coronavirus disease 2019 is an infectious respiratory syndrome caused by the virus called SARS-CoV-2, belonging to the family of coronaviruses. The first ever cases were detected during the 2019-2020 pandemic. Coronaviruses can cause a common cold or more serious diseases such as Middle Eastern Respiratory Syndromes (MERS) and Severe Acute Respiratory Syndrome (SARS). They can cause respiratory, lung and gastrointestinal infections with a mild to severe course, sometimes causing the death of the infected person. This new strain has no previous identifiers and its epidemic potential is strongly associated with the absence of immune response/reactivity and immunological memory in the world population, which has never been in contact with this strain before. Most at risk are the elderly, people with pre-existing diseases and/or immunodepressed, dialyzed and transplanted patients, pregnant women, people with debilitating chronic diseases. They are advised to avoid contacts with other people, unless strictly necessary, and to stay away from crowded places, also observing scrupulously the recommendations of the Istituto Superiore di Sanità.

In this article we detail the recommendations that must be followed by the nursing care staff when dealing with chronic kidney disease patients in dialysis or with kidney transplant patients. We delve into the procedures that are absolutely essential in this context: social distancing of at least one meter, use of PPI, proper dressing and undressing procedures, frequent hand washing and use of gloves, and finally the increase of dedicated and appropriately trained health personnel on ward.

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Economic impact of ferric carboxymaltose in haemodialysis patients

Abstract

Intravenous iron supplementation is essential in hemodialysis (HD) patients to recover blood loss and to meet the requirements for erythropoiesis and, in patients receiving erythropoietin, to avert the development of iron deficiency. In a recent real-world study, Hofman et al. showed that a therapeutic shift from iron sucrose (IS) to ferric carboxymaltose (FCM) in HD patients improves iron parameters while reducing use of iron and erythropoietin. The objective of this economic analysis is to compare the weekly cost of treatment of FCM vs IS in hemodialysis patients in Italy. The consumption of drugs (iron and erythropoietin) was derived from Hofman’s data, while the value was calculated at Italian ex-factory prices. The analysis was carried on the total patient sample and in two subgroups: patients with iron deficiency and patients anemic at baseline. In addition, specific sensitivity analyses considered prices currently applied at the regional level, simulating the use of IS vs iron gluconate (FG) and epoetin beta vs epoetin alfa. In the base-case analysis, the switch to FCM generates savings of -€12.47 per patient/week (-21%) in all patients, and even greater savings in the subgroups with iron deficiency -€17.28 (-27%) and in anemic patients -€23.08 (-32%). Sensitivity analyses were always favorable to FCM and confirmed the robustness of the analysis. FCM may represent a cost-saving option for the NHS, and Italian real-world studies are needed to quantify the real consumption of resources in dialysis patients.

 

Keywords: ferric carboxymaltose, intravenous iron supplementation, chronic kidney disease, hemodialysis, drugs consumption, economic impact

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Introduzione

La prevalenza dei pazienti con malattia renale cronica (MRC) è pari al 10-16% della popolazione adulta mondiale [1] con tassi di incidenza in aumento nel corso degli anni [1,2]. Questo trend rappresenta una sfida per i diversi Sistemi Sanitari e i pagatori in generale, particolarmente quando si consideri il più elevato consumo di risorse nei pazienti più anziani [3,4]. Soprattutto, va evidenziato che la mortalità legata alla MRC è quasi duplicata, tra il 1990 e il 2010, con un aumento, in termini di anni persi per morte prematura, inferiore solo a HIV-AIDS e diabete mellito [5].
 

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Cholecalciferol supplementation improves secondary hyperparathyroidism control in hemodialysis patients

Abstract

Introduction: Vitamin D deficiency is common among hemodialysis (HD) patients and is an important component in the pathogenesis of secondary hyperparathyroidism (SHPT). We herein report our experience on the impact of cholecalciferol supplementation on PTH levels in a group of HD patients.

Patients and methods: We selected 122 HD patients. The main selection criteria were 25-hydroxyvitamin D (25(OH)D) levels ≤30 ng/mL and SHPT defined as PTH levels >300 pg/mL or PTH levels between 150-300 pg/mL during therapy with cinacalcet or paricalcitol. 82 patients agreed to receive cholecalciferol at the fixed dose of 25,000 IU per week orally for 12 months, while the remaining 40 represented the control group. The main endopoints of the study were the reduction in PTH levels ≥30% compared to baseline values and the increase of 25(OH)D levels to values >30 ng/mL.

Results: At follow-up PTH levels decreased in the supplemented group from 476 ±293 to 296 ± 207 pg/mL (p<0.001), 25(OH)D levels increased from 10.3 ± 5.7 to 33.5 ± 11.2 ng/mL (p<0.001), serum calcium increased from 8.6 ± 0.5 to 8.8 ± 0.6 mg/dL (p<0.05) while serum phosphorus did not change. In this group the mean doses of paricalcitol were significantly reduced, from 8.7 ± 4.0 to 6.1 ± 3.9 µg/week (p<0.001). Moreover, in this group there were a significant increase of hemoglobin levels, from 11.6 ± 1.3 to 12.2 ± 1.1 g/dL (p <0.01) and a significant reduction of erythropoietin doses (p<0.05). In the control group the 25(OH)D and PTH levels did not change, while cinacalcet doses increased from 21 ±14 to 43 ± 17 mg/d (p<0.01).

Conclusions: Vitamin deficiency is very common in HD patients. Cholecalciferol treatment significantly increased serum 25(OH)D levels, significantly decreased PTH levels and paricalcitol doses, concurrently entailing a better control of anemia. 

Keywords: vitamin D, cholecalciferol, hemodialysis, secondary hyperparathyroidism, paricalcitol

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Introduzione

L’iperparatiroidismo secondario (IPS) inizia come un processo adattativo ma in ultimo, a seguito del ridursi della funzione renale, della ridotta escrezione di fosfati, della ridotta produzione di vitamina D e dell’ipocalcemia, si trasforma in un processo patologico [1]. È opinione comune che bassi livelli sierici di vitamina D siano la causa del bilancio negativo del calcio, dell’IPS e della patologia ossea. Le concentrazioni sieriche di 25-idrossivitamina D (25(OH)D) sono il principale indice del patrimonio di vitamina D del nostro organismo e sono utilizzate per definire uno stato carenziale di vitamina D [2]. Nelle linee guida National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (NKF–KDOQI), livelli sierici di 25(OH)D <5 ng/mL sono utilizzati per indicare una grave deficienza di vitamina D, livelli tra 5 e 15 ng/mL indicano una lieve insufficienza, livelli tra 16 e 30 ng/mL indicano un’insufficienza, mentre livelli maggiori di 30 ng/mL vengono considerati ottimali, anche se non vi è unanime consenso su quali siano i livelli sierici di vitamina D da considerare ottimali [3, 4].

 

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Management of hemodialysis patient subject to medical-nuclear investigation

Abstract

In recent years imaging techniques that use radionuclides have become more and more clinically relevant as they can provide functional information for specific anatomical districts. This has also involved nephrology, where radionuclides are used to study patients with different degrees of renal function failure up to terminal uremia. Although chronic kidney disease, and dialysis in particular, may affect the distribution and the elimination of radiopharmaceuticals, to date there are no consistent data on the risks associated with their use in this clinical context. In addition to the lack of data on the safety of radio-exposure in dialysis patients, there is also a shortage of information concerning the risk for healthcare staff involved in conducting the dialysis sessions performed after a nuclear test.

This study, performed on 29 uremic patients who underwent hemodialysis immediately after a scintigraphic examination, assessed the extent of radio-contamination of the staff and of hemodialysis devices such as monitor, kits and dialysate. The data collected has been used to quantify the radiological risk in dialysis after the exposure to the most common radionuclides.

 

Keywords: chronic kidney disease, imaging, radionuclides, hemodialysis, scintigraphy, radiological risk

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Introduzione

Negli ultimi decenni l’evoluzione delle metodiche di imaging ha contribuito significativamente al miglioramento dell’accuratezza diagnostica in medicina. Tra le varie metodiche, quelle utilizzanti radionuclidi, per le caratteristiche in esse presenti, hanno permesso di studiare aspetti particolari della patologia umana. La medicina nucleare usa il principio del tracciante. Le radiazioni, principalmente fotoni gamma, emesse dal radionuclide vengono convertite in immagini planari o tomografiche attraverso la Gamma Camera. Grazie alla versatilità dei radionuclidi, la medicina nucleare trova applicazione in diversi ambiti della clinica [1].

Secondo i dati UNSCEAR 2000 ogni anno vengono effettuati nel mondo circa 32 milioni di esami di medicina nucleare [2]. La crescente diffusione dell’esame scintigrafico e della Tomografia ad Emissione di Positroni (PET), nel corso dell’ultimo decennio, deriva principalmente dalla loro notevole capacità di integrazione e/o sostituzione delle classiche metodiche di imaging pesante (TC, RM, etc.). La scintigrafia è una tecnica di diagnostica funzionale che, previa somministrazione di un tracciante radioattivo (che si distribuisce nel corpo in base alle sue proprietà chimiche e biologiche), ne valuta e/o quantifica la distribuzione negli organi e nei tessuti che si vogliono studiare. La PET è un esame diagnostico che prevede l’acquisizione di immagini fisiologiche basate sul rilevamento di due fotoni gamma che viaggiano in direzioni opposte. Questi fotoni sono generati dall’annientamento di un positrone con un elettrone nativo. La scansione PET, eseguita con fluorodesossiglucosio (FDG), fornisce informazioni metaboliche qualitative e quantitative. L’FDG è un analogo radiomarcato del glucosio che viene assorbito dalle cellule metabolicamente attive come le cellule tumorali. Le scansioni PET sono in grado di dimostrare un’attività metabolica anormale prima che si siano verificati cambiamenti morfologici. L’attività metabolica dell’area di interesse viene valutata sia mediante ispezione visiva delle immagini sia misurando un valore semi-quantitativo dell’assorbimento di FDG chiamato valore di assorbimento standardizzato (SUV). L’applicazione clinica più comune della PET è in oncologia, dove viene impiegata per differenziare le lesioni benigne dalle lesioni maligne, monitorare l’effetto della terapia su neoplasie conosciute, riposizionare e rilevare la recidiva del tumore; viene anche utilizzata in cardiologia, per la valutazione di aree di ischemia, e in neurologia, nella diagnosi differenziale di demenza e sindrome di Parkinson [3,4].

 

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Covid-19 in patients on dialysis: infection prevention and control strategies

Abstract

Covid-19 is a disease caused by a new coronavirus presenting a variability of flu-like symptoms including fever, cough, myalgia and fatigue; in severe cases, patients develop pneumonia, acute respiratory distress syndrome, sepsis and septic shock, that can result in their death. This infection, which was declared a global epidemic by the World Health Organization, is particularly dangerous for dialysis patients, as they are frail and more vulnerable to infections due to the overlap of multiple pathologies. In patients with full-blown symptoms, there is a renal impairment of various degrees in 100% of the subjects observed. However, as Covid-19 is an emerging disease, more work is needed to improve prevention, diagnosis and treatment strategies. It is essential to avoid nosocomial spread; in order to control and reduce the rate of infections it is necessary to strengthen the management of medical and nursing personnel through the early diagnosis, isolation and treatment of patients undergoing dialysis treatment. We cover here a series of recommendations for the treatment of dialysis patients who are negative to the virus, and of those who are suspected or confirmed positive.

Keywords: Covid-19, hemodialysis, transmission, prevention

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Introduzione

La malattia da Coronavirus 2019 (Covid-19), appartiene alla grande famiglia di virus a RNA che possono essere isolati in diverse specie di animali [1] e che, per ragioni ancora sconosciute, possono attraversare le barriere della specie e possono causare nell’uomo malattie che vanno dal comune raffreddore a patologie più gravi come la SARSr-CoV1e la MERS. Il 30 gennaio 2020 l’Organizzazione Mondiale della Sanità ha dichiarato ufficialmente l’epidemia Covid-19 un’emergenza di sanità pubblica di interesse internazionale [2].

I sintomi clinici dei pazienti comprendono febbre (44%-98%), tosse secca (68%-76%), mialgia (18%) ed affaticamento (18%); i pazienti in gravi condizioni possono presentare respiro affannoso, rantoli umidi nei polmoni e suoni del respiro indeboliti fino alla polmonite bilaterale, sindrome da distress respiratorio acuto (ARDS), sepsi, shock settico e morte [3]. Sulla base dell’indagine epidemiologica attualmente in corso, il periodo di incubazione della malattia è generalmente compreso tra 3 e 7 giorni, con un massimo di 14 giorni [2] e la trasmissione da uomo a uomo avviene attraverso goccioline di saliva o con contatto diretto; a differenza della SARS, il Covid-2019 è responsabile dell’infezione anche se il paziente è asintomatico [2].

 

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The new frontier in endovascular treatment of arteriovenous fistula stenosis: the role of ultrasound-guided percutaneous transluminal angioplasty

Abstract

Native arteriovenous fistula is the preferred vascular access because of it does not usually cause infections and seems to be closely related with prolonged patient survival, compared to prosthetic grafts and central venous catheters; it also is cost effective. Venous stenosis is one of the main causes of AVF failure. It is caused by a number of upstream and downstream events. The former group comprises hemodynamic and surgical stressors, inflammatory stimuli and uraemia, while downstream events involve the proliferation of smooth muscle cells and myofibroblasts and the development of neo-intimal hyperplasia. Percutaneous transluminal angioplasty is the gold standard for arteriovenous fistula stenosis. It allows the visualization of the whole vascular circuit and the immediate use of the vascular access for the next dialysis session. Ultrasound-guided percutaneous endovascular angioplasty is a feasible and safe alternative to conventional fluoroscopic technique: it is equally effective in treating arteriovenous fistula stenosis, but it presents the advantage of not using contrast media or ionizing radiation. The aim of this review is to report the latest evidence on cellular and molecular mechanisms that contribute to the development of neo-intimal hyperplasia, as well as the current and future therapeutic perspectives, especially concerning the use of anti-proliferative drugs, and the efficacy of the ultrasound-guided angioplasty in restoring and maintaining the vascular access patency over time.

Key words: Percutaneous angioplasty, ultrasound, arteriovenous fistula, hemodialysis, stenosis.

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Introduzione

La prevalenza della malattia renale cronica terminale aumenta di anno in anno. Nel 2010, il numero dei pazienti sottoposti a terapia emodialitica in tutto il mondo era pari a 2,618 milioni e, secondo alcune recenti stime, è destinato a crescere fino a 5,439 milioni entro il 2030 [1]. A livello nazionale, i dati estrapolati dal Report 2015 del Registro Italiano di Dialisi e Trapianto evidenziano un’incidenza e una prevalenza di 154 pazienti/pmp e di 770/pmp rispettivamente [2]. Indipendentemente dalla metodica utilizzata, il buon funzionamento dell’accesso vascolare (AV) rappresenta un requisito irrinunciabile per una ottimale adeguatezza dialitica. 

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Retroperitoneal renal hemorrhage: experience of our dialysis center

Abstract

The aging of the uremic population, the increasingly common use of anticoagulants, antiplatelet agents e heparin, during hemodialysis, can expose our patients to a greatest risk of bleeding. Spontaneous retroperitoneal hematomas are a fairly rare and potentially fatal condition.
We describe 5 clinical cases of retroperitoneal hemorrhage that we observed during 10 years in our department, focusing on modalities of symptom onset, clinical-laboratory picture and treatment modalities

Keywords: Retroperitoneal hemorrhage, hemodialysis

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INTRODUZIONE

Gli ematomi retroperitoneali e in particolare quelli spontanei (in assenza di trauma o danno iatrogeno) sono una patologia abbastanza rara e potenzialmente fatale.

 

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Microbiological quality of hemodialysis water: what are the risk factors?

Abstract

Background A dialyzed patient weekly gets in touch with a large amount of water (on average 350 liters) through the dialysis bath. It is therefore essential that this solution would have a high quality and purity. The aim of our study was to monitor the microbiological quality of the hemodialysis water in order to identify possible factors that could affect it.

Methods We conducted a cross-sectional study from January 2015 to October 2017 collecting the dialysis water in AOU Careggi. Samples were aseptically collected by specialized technicians and then transported under ice at 4 ° C to the Laboratory of Biological Hazards of USL Toscana Centro for laboratory analyses.

Results 126 water samples were collected. Coliforms, E. coli, Staphylococcus aureus, enterococci were not detected. Pseudomonas aeruginosa was found in only one sample. Both for CFU at 37 ° C and at 22 ° C, the type of device represented the only statistically significant risk factor (OR 15.21 and OR 10.25 respectively): SDS devices had a significantly higher risk of being positive for CFU at 37 ° C and 22 ° C.

Conclusions As our study demonstrated, the system producing dialysis water must be constantly monitored, especially in cases of SDS devices which may be subjected more frequently to a higher contamination, due to their discontinuous use.

 

Keywords: surveillance, hemodialysis, infections

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INTRODUZIONE

L’emodialisi è uno dei trattamenti per pazienti con insufficienza renale acuta e cronica e, alla fine del 2010, quasi un milione di persone erano in trattamento dialitico, il 60% delle quali in 5 paesi: USA, Giappone, Germania, Brasile, Italia (1).

Un paziente in dialisi entra in contatto settimanalmente con un’ingente quantità d’acqua tramite il bagno di dialisi, in media 350 litri. È pertanto essenziale che questa soluzione abbia un’elevata qualità e purezza in termini di corretta composizione elettrolitica, bassa concentrazione o assenza di inquinanti chimici organici e inorganici, bassa concentrazione o assenza di batteri, lieviti, funghi ed endotossine. Va ricordato che il circuito idraulico delle macchine dialitiche può promuovere la crescita batterica e la formazione di biofilm. Questi ultimi possono andare incontro a colonizzazioni batteriche che possono essere rilasciate o produrre endotossine capaci di penetrare le membrane dialitiche (2, 3) .

 

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