Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial.

Background: The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods: FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 µg/L) or lower (100-200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period. Results: The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions: These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD

Analiza wstępowania szpitalnych zakażeń układu moczowego w 10-letniej obserwacji oddziału chorób wewnętrznych i nefrologii w Małopolsce

Wstęp: Zakażenia szpitalne są jednym z poważniejszych zagrożeń zdrowia pacjenta podczas hospitalizacji. Wśród nich zakażenia szpitalne HAI (Healthcare – Associated Infections). Najczęściej występującą formą są szpitalne zakażenia układu moczowego (UTI – Urinary Tract Infection). Cel: W celu zbadania częstości występowania szpitalnych zakażeń układu moczowego poddano analizie strukturę zakażeń szpitalnych występujących u pacjentów hospitalizowanych w Oddziale Chorób Wewnętrznych i Nefrologii Szpitala Wojewódzkiego im. Św. Łukasza w Tarnowie. Materiał i metody: Analizowano dane dotyczące 13 965 pacjentów hospitalizowanych w Oddziale Chorób Wewnętrznych i Nefrologii w latach od 2006 do 2015. W analizie materiału wykorzystano standardowe metody epidemiologiczne i ujednolicone definicje zakażeń szpitalnych wydane przez ECDC (European Center for Disease Prevention and Control) oraz CDC (Centers for Disease Control and Prevention). Wyniki: Wykryto 237 szpitalnych UTI co stanowiło 33% wszystkich zakażeń szpitalnych wykrytych w badanym oddziale. Zachorowalność wynosiła 1,7%, w tym: 1,5% dla potwierdzonych mikrobiologicznie zakażeń (UTI-A: Microbiologically Confirmed Symptomatic UTI) i 0,2% bez potwierdzenia mikrobiologicznego (UTI-B: Not Microbiologically Confirmed Symptomatic UTI). Współczynnik gęstości zachorowań na 1000 osobodni pobytu (ID – density incidence /1000 osobodni pobytu) wynosił 0,2/1000. Rozpoznano 168 przypadków zakażeń UTI związanych z cewnikiem moczowym i 69 przypadków bez cewnika moczowego. Współczynnik gęstości zachorowań dla UTI z cewnikiem moczowym wynosił 3,3 na 1000 osobodni z cewnikiem moczowym. Wśród czynników etiologicznych, które izolowano z materiałów pochodzących od pacjentów z zakażeniem układu moczowego (UTI) dominowały: Escherichia coli 63 (29%), Enterococcus spp. 37 (16%), Klebsiella spp. 23 (11%). Wnioski: Dziesięcioletnia obserwacja szpitalnych UTI występujących w oddziale chorób wewnętrznych i nefrologii wykazała możliwość przeprowadzenia bardzo dokładnej analizy epidemiologicznej tych zakażeń. Porównanie gęstości występowania szpitalnych UTI uzyskane w badanym oddziale z odnotowaną w programach CDC pozwala wnioskować, iż sytuacja epidemiologiczna w badanym oddziale nie odbiega znacząco od sytuacji w innych krajach.Introduction: Hospital-acquired infections are one of the most serious health threats during a patient’s stay in hospital, including healthcare associated infections (HAI). The most typical form of hospital-acquired infections is urinary tract infection (UTI). Objective: To examine the frequency of appearing UTIs, the structure of UTIs in in-patients in the department of internal medicine and nephrology at Saint Lucas’s general hospital in Tarnów was analysed. Materials and methods: Data analysis of 13 965 in-patients staying in the department of internal medicine and nephrology from 2006 to 2015 was carried out. To investigate these data epidemiological methods and standard definitions of hospital- acquired infections issued by European Center for Disease Prevention as well as Control and Centers for Disease Control and Prevention were used. Results: 237 hospital-acquired UTIs were revealed, which is 33% of all UTIs revealed in the investigated ward. The UTI incidence rate was 1.7% including 1.5% for microbiologically confirmed symptomatic UTIs and 0.2% not microbiologically confirmed symptomatic UTIs. The incidence density rate per 1 000 person-days was 0.2 over 1 000. The number of revealed catheter-related cases was 168, and not catheter-related cases – 69. The incidence density rate of UTIs associated with urinary catheters was 3.3 per 1 000 person-days. The dominant etiological factors, which were taken to be detected from the infected patients’ specimens, were: Escherichia coli 63 (29%), Enterococcus spp. 37(16%), Klebsiella spp. 23 (11%). Conclusions: A 10 year observation of UTIs, which have appeared in the department of internal medicine and nephrology, allowed to conduct the accurate analysis of these infections. The comparison of urinary tract infection rates done in the investigated ward, and recorded in the Research Participation Programs at the Centers for Disease Control and Prevention (CDC), allows to draw the conclusion that the presented epidemiological situation does not differ significantly from other countries

Carpal tunnel syndrome in hemodialysis patients as a dialysis-related amyloidosis manifestation : incidence, risk factors and results of surgical treatment

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common complication of dialysis-related amyloidosis (DRA) developing in patients on long-term dialysis therapy. The aim of this study was to evaluate the incidence of CTS and identify factors influencing the development of CTS in patients on maintenance hemodialysis, as well as results of its surgical treatment. MATERIAL/METHODS: The study included 386 patients, among whom CTS was diagnosed in 40 patients (10.4%) on the basis of signs and physical symptoms, as well as by nerve conduction. The group of patients with CTS and the group of patients without CTS were compared according to age (mean 54.50 vs. 56.48 years) and duration of dialysis treatment. Initial analysis of CTS incidence by sex, presence of anti-HCV antibodies, and location of arterio-venous fistula (AV fistula) was undertaken. RESULTS: Duration of dialysis treatment was the statistically significant risk factor for the development of CTS (16.05 vs. 4.51 years; p<0.0001). Among patients treated for a long period on hemodialysis (20–30 years), 100% required surgical release procedures, while 66.66% of those treated for 15–19 years, 42.1% of those treated for 10–14 years, and 1.6% of those treated for less than 10 years. CTS was diagnosed more often in anti-HCV-positive patients as compared with anti-HCV-negative patients (47.5 vs. 6.9%; p<0.0001). No significant differences were found when comparing CTS incidence by sex or between the development of CTS requiring surgical release intervention and location of the AV fistula. CONCLUSIONS: Surgical release procedure of the carpal tunnel gave good treatment results in patients with CTS