Continuous Erythropoietin Receptor Activator for the Treatment of Chronic Dialysis Patients with Renal Anemia in Daily Clinical Practice in Poland: A Non-Interventional, Multi-Center, Pragmatic NAVIGO Trial.

BACKGROUND: Renal anemia is one of the most common complications of chronic kidney disease (CKD). This real-life study assessed the effectiveness of methoxy polyethylene glycol-epoetin beta, a continuous erythropoietin receptor activator (C.E.R.A.), for the treatment of CKD-associated anemia in patients receiving dialysis in daily clinical practice. METHODS: 247 patients receiving chronic intermitted dialysis in 26 centers in Poland with CKD-associated symptomatic anemia, ESA-naïve, and with balanced iron stores in the investigators' opinion were enrolled this real-life study. Over 12 months, the following data were collected: hemoglobin (Hb) concentration and dosage, route of administration and dosing scheme of C.E.R.A., dialysis adequacy, adverse events, iron therapy, and blood transfusions. RESULTS: During the treatment, a Hb concentration of ≥10 g/dL was noted in 90.9% of hemodialysis patients (n = 224) and 96.0% of peritoneal dialysis patients (n = 23). At baseline, 7.8% of patients had a Hb concentration of 10-12 g/dL, which increased to 63.3% after 12 months. The median time when Hb concentration was maintained within 10-12 g/dL was 115.2 (interquartile range 49.1-188.7) days. A Hb concentration ≥12 g/dL was observed after 7 months of treatment in a maximum of 24.1% of hemodialysis patients, and 31.8% of peritoneal dialysis patients. The median time elapsed between the start of treatment and the first Hb concentration >10 g/dL was 42.0 (21.0-78.2) days. C.E.R.A. was well tolerated. CONCLUSIONS: C.E.R.A. corrects CKD-associated anemia in dialysis patients, and maintains Hb levels within the recommended target range. The study also confirmed the acceptable safety profile of the drug.

Overcoming Inequity in Access to Kidney Transplantation: A Quality Improvement Project.

BACKGROUND: In 2018, DaVita dialysis clinics in Poland introduced a new pathway to improve the referral of dialysis patients for kidney transplantation. It was designed to meet formal requirements for timely referral for transplant assessment and measures to have the patient "active" on the waiting list. The pathway aimed to mitigate the existing inequitable access to transplantation surgery for patients with end stage kidney disease under the care of ambulatory dialysis clinics. The consequences to the patient of lack of contact with nephrologist when called in for transplant surgery during out-of-office hours was a major concern. We reviewed the effectiveness of whether the new procedure impacted facilitating a patient's call for a transplant surgery when dialysis clinics were not operating. METHODS: We collected data on the number of transplantations performed and the number of calls for surgery according to a conventional or new procedure over a 30-month period. RESULTS: In our study, 269 patients received a deceased donor kidney transplant, and 205 candidates (75%) were called for transplantation during the working hours of dialysis clinics, according to the standard procedure, of which 4 patients were discharged for various reasons. In addition, 69 candidates (25%) were called outside clinic working hours through the new procedure process, of which 1 patient was discharged during a phone call due to infection. CONCLUSIONS: DaVita's Poland new transplant access procedure effectively supports a patient's call for transplantation during outpatient dialysis clinics' closure hours.

Improvements in six aspects of quality of care of incident hemodialysis patients - a real-world experience.

BACKGROUND: The transition from chronic kidney disease stage 5 to initiation of hemodialysis has gained increased attention in recent years as this period is one of high risk for patients with an annual mortality rate exceeding 20%. Morbidity and mortality in incident hemodialysis patients are partially attributed to failure to attain guideline-based targets. This study focuses on improvements in six aspects of quality of dialysis care (adequacy, anemia, nutrition, chronic kidney disease-mineral bone disorder (CKD-MBD), blood pressure and vascular access) aligning with KDIGO guidelines, during the first 6 months of hemodialysis. METHODS: We analyzed patient demographics, practice patterns and laboratory data in all 3 462 patients (mean age 65.9 years, 41% females) on hemodialysis (incident <90 days on hemodialysis, n=603, prevalent ≥90 days on hemodialysis, mean 55 months, n=2 859) from all 56 DaVita centers in Poland (51 centers) and Portugal (5 centers). 80% of patients had hemodialysis and 20% hemodiafiltration. Statistical analyses included unpaired and paired Students t-test, Chi-2 analyses, McNemar test and logistic regression analysis. RESULTS: Incident patients had lower Kt/V (1.4 vs 1.7, p<0.001), lower serum albumin (37 vs 40 g/l, p=0.001), lower Hb (9.9 vs 11.0 g/dl, p<0.001), lower TSAT (26 vs 31%, p<0.001), lower iPTH (372 vs 496 pg/ml, p<0.001), more often a central venous catheter (68 vs 26%, p<0.001), less often an AV fistula (34 vs 70 %, p<0.001) compared with all prevalent patients. Significantly more prevalent patients achieved international treatment targets. Improvements in quality of care was also analyzed in a subgroup of 258 incident patients who were followed prospectively for 6 months. We observed significant improvements in Kt/V (p<0.001), albumin (p<0.001), Hb (p<0.001) transferrin saturation (TSAT, p<0.001), iPTH (p=0.005) and an increased use of AV fistula (p<0.001). Furthermore, logistic regression analyses identified treatment time and TSAT as major factors influencing the attainment of adequacy and anemia treatment targets. CONCLUSION: This large real-world European multicenter analysis of representative incident hemodialysis patients indicates that the use of medical protocols and medical targets assures significant improvements in quality of care, which may correspond to better outcomes. A selection bias of survivors with less comorbidities in prevalent patients may have influenced the results.

Influence of gender and age on haemodialysis practices: a European multicentre analysis.

BACKGROUND: Women of all ages and elderly patients of both genders comprise an increasing proportion of the haemodialysis population. Worldwide, significant differences in practice patterns and treatment results exist between genders and among younger versus older patients. Although efforts to mitigate sex-based differences have been attempted, significant disparities still exist. METHODS: This retrospective cohort study included all 1247 prevalent haemodialysis patients in DaVita units in Portugal (five dialysis centres, n = 730) and Poland (seven centres, n = 517). Demographic data, dialysis practice patterns, vascular access prevalence and the achievement of a variety of Kidney Disease: Improving Global Outcomes (KDIGO) treatment targets were evaluated in relation to gender and age groups. RESULTS: Body weight and the prescribed dialysis blood flow rate were lower in women (P < 0.001), whereas treated blood volume per kilogram per session was higher (P < 0.01), resulting in higher single-pool Kt/V in women than in men (P < 0.001). Haemoglobin was significantly higher in men (P = 0.01), but the proportion of patients within target range (10-12 g/dL) was similar. Men more often had an arteriovenous fistula than women (80% versus 73%; P < 0.01) with a similar percentage of central venous catheters. There were no gender-specific differences in terms of dialysis adequacy, anaemia parameters or mineral and bone disorder parameters, or in the attainment of KDIGO targets between women and men >80 years of age. CONCLUSIONS: This large, multicentre real-world analysis indicates that haemodialysis practices and treatment targets are similar for women and men, including the most elderly, in DaVita haemodialysis clinics in Europe.

Achievement of renal anemia KDIGO targets by two different clinical strategies - a European hemodialysis multicenter analysis.

BACKGROUND: The optimal treatment algorithm for iron therapy and the use of erythropoiesis-stimulating agents (ESA) in anemic hemodialysis (HD) patients has not been established. Hemoglobin (Hb) target levels can be achieved through more frequent intravenous (IV) iron use with lower ESA dose, or with less iron dosing but higher ESA. ESA therapy to correct anemia may result in severe arterial and venous thrombotic complications and the evidence base evaluating hard clinical outcomes related to the use of IV iron is sparse. METHODS: A total of 1247 maintenance HD patients from 12 dialysis centers in Portugal (n = 730) and Poland (n = 517) were considered. We assessed achievement of KDIGO renal anemia targets with focus on treatment strategies, which typically differ between countries. In Poland the use and dose of IV iron was 35-72% higher than that in Portugal (p <  0.001) during three consecutive months; use and dose of ESA was 61% higher in Portugal (5034 vs 3133 IU (adjusted)/week, p <  0.001). RESULTS: Mean Hb concentration was similar (11.0 vs 11.0 g/dL) in patients treated in both countries and the proportion of patients within KDIGO anemia target was 69.5% in Poland vs 65.8% in Portugal (NS). Ferritin and TSAT levels and the proportion of patients with TSAT > 20 and > 50% were both significantly higher in patients in Poland (88.8 and 14.6%) than in Portugal (76.3 and 5.7% respectively, p <  0.001). Significantly more patients in Poland had a ferritin concentration > 800 µg/L (35.6%) compared to Portugal (15.8%, p <  0.001). The ESA resistance index (ERI) was significantly higher in patients treated in Portugal (p <  0.001). Correlation analyses showed confounding by treatment indication in unadjusted models. Multiple and logistic regression analyses showed that with ferritin within KDIGO recommended range of 200-800 µg/L the odds for Hb within guidelines increased significantly. Annual gross mortality was 16% in Poland and 13% in Portugal (NS); there were no differences in cause-specific mortality. CONCLUSIONS: Administration of high doses of IV iron in routine clinical HD practice may not be associated with considerable harm. However, large randomized controlled trials are needed to provide absolute evidence of iron safety.

Renal anaemia treatment in haemodialysis patients in the Central and Eastern European countries in everyday clinical practice follow-up.

BACKGROUND: Chronic kidney disease is almost always accompanied by anaemia. Erythropoietin-stimulating agents (ESA) can increase haemoglobin concentration and thus reduce the frequency of anaemia-related complications including the cardiovascular events. AIM: The aim of the study was to collect prospective data on 12-month standard ESA therapy used in haemodialyzed patients in selected CEE countries as well as on cardiovascular complications, iron status and anaemia treatment. PATIENTS AND METHODS: Fifty centres in 3 countries participated in the study. A group of 398 haemodialysed stable patients (M-231, F-167) aged 19-90 years (57.5 ± 14.7) on standard ESA therapy for chronic renal anaemia were recruited. Twelve-month prospective data on iron parameters, ESA therapy and cardiovascular events were collected. The use of iron, folic acid and blood transfusions were also assessed. Patient were divided into three groups according to ESA therapy start: group A-patients who received ESA after start of haemodialysis, group B-patients who received ESA within 3 months from the day of first haemodialysis and group C-patients who had received ESA more than 3 months before haemodialysis. Chi(2) test for qualitative data and Kruskall-Wallis test for quantitative data with p < 0.05 were used in statistical analysis. RESULTS: At prestudy period, the mean weekly dose of ESA in group C was statistically lower than in the remaining two groups (3,823 ± 3,169 vs. 5,276 ± 2,915 and 6,427 ± 3,441 units/week, p < 0.001), but during prospective phase of the study the doses did not differ among groups A, B and C. No major fluctuation of ESA administration schedule was observed during the study in the groups; however, at majority of visits, the mean frequency of ESA administration in group C was statistically higher than in groups A and B. At baseline visit, the haemoglobin concentration in group A patients (10.86 ± 1.34 g/dL) was slightly lower than in group B (11.26 ± 1.43 g/dL) and group C (10.98 ± 1.35 g/dL) (p = 0.025), but at subsequent visits these differences disappeared and mean haemoglobin concentration was stable around 11 g/dL. Ferritin concentration increased from 280 ± 241 at baseline to 506 ± 405 at month 12, and no important differences in the groups were observed. The other haematological parameters (haematocrit, iron concentration) remained stable during the entire study. The frequency of blood transfusion and total volume of blood in group C were lower than in groups A and B. During the prospective 12-month follow-up, 23 (5.8 %) of the patients died and 35 (8.8 %) were transplanted. No differences in death or transplantation rate were observed among groups A, B and C. The number of patients with adverse events, serious adverse events or drug-related adverse events in all groups was similar. In conclusion, ESA therapy increased haemoglobin concentration and no major differences in haematological parameters among the groups were observed during the entire study irrespective of early versus late start. Mortality, cardiovascular events or other adverse events were similar among the groups during the observation period; however, the limitation of the study is the sample size.

[Influence of elevated homocystein level and selected lipid parameters in kidney transplant patients on the progression of atherosclerotic changes assessed by intima-media thickness index (CCA-IMT)]. / Ocena wplywu hiperhomocysteinemii i wybranych parametrów lipidowych u chorych po przeszczepieniu nerki na rozwój zmian miazdzycowych ocenianych wskaznikiem intima-media (CCA-IMT).

UNLABELLED: The aim of the study was to evaluate the influence of elevated homocystein (Hcy) level and selected lipid parameters on the progression of atherosclerotic changes in patients after kidney transplantation (KTx). PATIENTS AND METHODS: The study included 51 pts (17 F, 34 M) aged 15-62 years (median 38.1) after cadaver KTx. The mean observation period equaled 21.2 months (6-24 months); while total observation period was 90 patients/ years. Hcy levels was measured using HPLC, Lp(a) and Apo-B levels using the nephelometric method and total cholesterol with its' HDL and LDL fractions, triglycerides and creatinine based on the Hitachi 917 analyzer. Patients' blood was drawn before renal transplantation and 3, 6, 9, 12, 15, 18, 21 and 24 months after KTx. Common carotid artery intima media thickness (CCA-IMT) was evaluated by ultrasound on 14 days, 12 and 24 months after KTx. RESULTS: CCA-IMT correlated significantly with Hcy levels after 12 months (R=0.53; p=0.0009) and 24 months (R=0.38; p=0.0356) after KTx. Significant differences were found 12 and 24 months after KTx in CCA-IMT between patients with normal (<15 micromol/l) and increased (>15 micromol/ l) mean Hcy concentrations: p=0.0035 and p= 0.015, respectively. Analyzing changes in CCA-IMT, significant differences were noted when comparing the CCA-IMT increment after 12 and 24 months post KTx in patients with normal (< or =15 micromol/l) and increased (>15 micromol/l) homocystein concentrations: p=0.049 and p=0.0039, respectively. Increment of CCA-IMT 12 months after KTx, significantly correlated with mean total cholesterol level (R=0.35; p=0.0333), whereas 24 months after procedure correlated significantly with 0.0315). CONCLUSIONS: Hcy level is an independent risk factor for atherosclerosis development in patients after KTx. Elevated Hcy level as well as increased cholesterol and Lp(a) levels enhance the progression of atherosclerotic changes evaluated by CCA-IMT in KTx patients.

Renal anemia treatment with ESA in hemodialysis patients in relation to early versus late referral in everyday clinical practice in Central and Eastern European countries: baseline data.

The aim of the study was to collect retrospective data on renal anemia management, comorbidities and prospective data on 12-month standard care erythropoiesis-stimulating agent (ESA) therapy used in 398 hemodialyzed patients in selected Central and Eastern European countries (50 centers in 3 countries). Patients were divided into three groups according to ESA therapy start: group A-ESA (after start of hemodialysis, HD), B-ESA (within 3 months from start of HD), C-ESA (more than 3 months before HD). At the chronic kidney disease diagnosis, hemoglobin in all patients was 10.3 ± 2.3 g/dl; however, ferritin, iron, TSAT were within reference limits. Early ESA therapy (C) was administered to 10% of patients only. 47% of patients received ESA after start of dialysis. Before study, the mean weekly ESA dose in group C was statistically lower than in groups B and A (p < 0.001). At baseline visit, hemoglobin in group A patients was slightly lower than in group B and C patients (p = 0.025). In conclusion, in Central and Eastern European countries renal anemia therapy with ESA starts shortly before or after start of HD. This highlights important differences in standard care in Eastern Europe. However, paradoxically, due to the tight reimbursement policy we foresee the clinical implications of the TREAT trial for the chronic kidney disease population.

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.

[Cardiovascular calcification and five-years mortality in patients on maintenance hemodialysis]. / Zwapnienia w ukladzie sercowo-naczyniowym a 5-letnia smiertelnosc pacjentów leczonych powtarzanymi hemodializami.

The very high cardiovascular mortality and morbidity in hemodialyzed patients (HD) is strongly associated with cardiovascular calcification. The aim of the study was to find the predictors of mortality in HD patients during 5-years observation period. The study group was composed of 64 patients (35 F, 29 M) aged 25-75 years (mean 48.9) hemodialyzed three times a week for 12-275 months (mean 77.8). The levels of hemoglobin, total protein, albumin, Ca, P, Ca x P, iPTH, cholesterol, triglycerides, fibrinogen, insulin, homocysteine, leptin, procalcitonin, CRP, IL-6, TGF-beta, PDGF were assessed and all patients underwent Calcium Score (CS) of coronary arteries (CACS) calculation using MSCT and B-mode ultrasound of carotid arteries for intima-media thickness (CCA-IMT), as well as echocardiographic assessment with LVMI calculation and heart valves evaluation at the start of observation. The self-elaborated Cumulative Calcification Index (CCl) was calculated as a sum of CACS Index according to Rumberger et al. (CS<10-0, 10400 - 3 points); number of calcified plaques in carotid arteries (0-0, 1 - 1, 2 - 2, 3 and more - 3 points) and the number of calcified heart valves. At the start of the study the median value of CCl was 4 and interquartile range 4. Only 2 (3%) patients were free of any type of cardiovascular calcification (CCl =0), 15 (23%) patients had minimal calcification (CCl 1 to 2 points), 33 (52%) average (2 - 6 points) and 14 (22%) patients had severe calcification (CCl>6). 21 (32,8%) patients died during observation period. Patients who died were older (56.9 vs. 45.3 yrs.) and had higher CS at the start (1275 vs. 356), higher CCA-IMT (0.948 vs. 0.687 mm) and CCl (6.15 vs. 3.63) values. Those patients had also higher CRP (0.645 vs. 0.245 mg/dl) and IL-6 (10.16 vs. 4.15 pg/ml) levels (p<0.05). LVMI and mean: hemoglobin, total protein, albumin, Ca, P, Ca x P, iPTH, cholesterol, triglycerides, fibrinogen, insulin, homocysteine, leptin, procalcitonin, TGF-beta as well as PDGF levels did not differ between the groups. In logistic regression model (p<0.00002), among tested parameters only CCl was an independent and statistically significant factor of mortality with OR=1.82 per every point of CCl (p<0.0003). Cardiovascular calcification expressed as CCl confirmed to be a strong predictor of mortality in HD patients.

Correlation between fat mass and blood pressure in healthy children.

Obesity is a well-known risk factor for arterial hypertension. The aim of this study was to analyze which surrogate marker of adiposity, i.e., body mass index (BMI) or fat mass (FM), as measured by bioimpedance analysis (BIA), best correlated with blood pressure in healthy children. Body weight, height, and casual blood pressure (BP) were measured in 193 healthy children (103 boys), aged 8-16 years. Body composition was determined by BIA. The correlation between BMI and age was linear, whereas the correlation between percentage of FM and age was nonlinear and it was different in boys and girls. Blood pressure standard deviation scores (SDS) correlated with FM SDS (BIA) over the entire normal range (systolic: r = 0.26, p = 0.002; diastolic: r = 0.33, p < 0.01). An evaluation of the children based on BP (three groups: BP < 50th percentile, 50th < BP > 95th percentile; BP > 95th percentile) revealed that hypertensive children had a higher BMI (17.6 vs. 19.4 vs. 26.2 kg/m(2), respectively) and a greater FM (14.0 vs. 16.8 vs. 30.2%, respectively). In conclusion, the divergence in FM in healthy boys and girls can be determined by BIA but not by BMI. In healthy children, BP within the entire normal range correlated with FM, children with established hypertension presented with a significantly higher FM. The study points to FM as an important determinant of BP pressure in obese and non-obese children.

[The assessment of heart function in children with chronic kidney disease (CKD)]. / Ocena funkcji serca u dzieci z przewlekla choroba nerek (PChN).

THE AIM OF THE STUDY: The echocardiography evaluation of cardiac function in children with CKD. PATIENTS AND METHODS: 30 children (17 males, 13 females), aged 2-20 yrs with CKD 2-5. Left ventricular (LV) dimensions, LV ejection fraction (EF) and LV mass index (LVMI), as well mitral inflow velocity (E/A waves) and isovolumetric relaxation time (IRT) were evaluated. RESULTS: Impaired diastolic heart function were ascertained in 12 patients (in 2 from 5 with CKD 3, in 3 from 10 with 4 and 7 from 14 with 5). Left ventricular hypertrophy was observed in 13 children with CDD 3-5 (4, 4, 5), and decreased ejection fraction in 2. CONCLUSIONS: The vast majority of children with chronic kidney disease demonstrate an impairment of diastolic cardiac function.

[Evaluation of polyneuropathy severity in chronic renal failure patients on continuous ambulatory peritoneal dialysis or on maintenance hemodialysis]. / Ocena stopnia nasilenia polineuropatii u chorych ze schylkowa niewydolnoscia nerek leczonych ciagla ambulatoryjna dializa otrzewnowa lub powtarzanymi hemodializami.

UNLABELLED: The aim of the study was to assess severity of injury of the peripheral nervous system of chronic renal failure patients on continuous ambulatory peritoneal dialysis (CAPD) or on maintenance hemodialysis (HD) diagnosed based on the electrophysiological testing as well as to establish the effect of adequate dialysis dose on peripheral nerve functioning. The study was performed in 53 patients (21 males, 32 females) on CAPD for mean 16.9 +/- 14.4 months and 68 patients (46 males, 22 females) on HD for mean 47.5 +/- 46.5 months. Both groups were age matched (48.9 +/- 12.4 vs. 50.6 +/- 11.9 yrs; p= NS). Patients with co-existing diseases that could lead to disturbances in nerve conduction were excluded from the study group. METHODS: Electrophysiological testing was performed using Medelec Shaphire 2ME equipment. Nerve conductivity testing was performed in motor and sensory fibres of right ulnar nerve, motor fibres of right fibular nerve and left tibial nerve as well as in sensory fibres of right calf nerve. In the sensory nerves there were assessed: amplitude of the evoked sensory response, latency of the response and conduction velocity. In the motor nerves there were analyzed amplitude of the compound muscle action potential, latency of the evoked response, F-wave minimal latency and conduction velocity. Polyneuropathy was diagnosed if abnormal results obtained in electrophysiological examination were found in at least two out of four tested nerves. To assess dialysis adequacy in the CAPD group weekly Kt/V (wKt/ V) and weekly creatinine clearance (WCrCI) were used and in the HD patients the following indices were measured: Kt/V, PRU, TAC and TAD. RESULTS: Polyneuropathy diagnosed based on the above described criteria, was found in 59 (86.8%) HD patients and in 41 (77.4%) CAPD patients (p= NS). The results of motor conductivity testing showed significantly longer distal latency in HD patients in comparison to the CAPD patients in fibular nerve (4.9 +/- 0.9 vs. 4.5 +/- 0.8 ms; p< 0.05) and F-wave latency in ulnar nerve (29.3 +/- 3.1 vs. 27.3 +/- 2.5 ms; p< 0.05), in fibular nerve (52.4 +/- 6.4 vs. 48.5 +/- 7.94 ms; p< 0.05), in tibial nerve (54.8 +/- 7.8 vs. 50.6 +/- 7.12 ms; p< 0.05) and also significantly lower conduction velocity in ulnar nerve (51.9 +/- 5.9 vs. 55.6 +/- 6.99 m/s; p< 0.05), in fibular nerve (41.2 +/- 5.9 vs. 44.5 +/- 5.5 m/s; p< 0.05), in tibial nerve (40.1 +/- 5.81 vs. 42.7 +/- 4.6 m/s; p< 0.05). Mean value of sensory response amplitude evoked in ulnar nerve was significantly higher in the CAPD treated patients than in HD patients (21.2 +/- 14.8 vs. 15.1 +/- 11.4 microV; p< 0.05) and distal latency in calf nerve was significantly shorter (2.1 +/- 1.0 vs. 2.4 +/- 0.6 ms; p< 0.05). Analysing the effect of dialysis on peripheral nerve functioning in the group of CAPD patients a statistically significant relationship between the severity of peripheral nerve injury and WCrCl was demonstrated. Mean value of WCrCl in patients without features of neuropathy was significantly higher (83.3 +/- 28.98 l/week/ 1.73m2) in comparison with those with diagnosed polyneuropathy (59.9 +/- 15.9 l/week/1.73m2) (p< 0.01). Analyzing effect of WCrCl on conduction velocity in the tested nerves there was demonstrated that in patients with WCrCl value at least 60 l/week/1.73m2, mean velocity values were higher, and the statistically significant difference was found for sensory (p< 0.05) and motor (p< 0.01) fibers of ulnar nerve. Mean value of residual renal clearance in the CAPD treated patients without features of sensory and motor nerve injury was significantly higher (2.9 +/- 1.8 ml/min) when compared to the patients with diagnosed polyneuropathy (1.4 +/- 1.3 ml/min) (p= 0.006). In the hemodialyzed group no statistically significant relationship was found between conduction velocity in the tested nerves and indices of dialysis efficiency (Kt/V, PRU) as well as degree of exposure to uremic toxemia described by TAC and TAD. CONCLUSIONS: Polyneuropathy is a common complication in patients with chronic renal failure independently of a kind of the therapy. Well preserved residual renal function in CAPD patients plays an important role in improving effectiveness of the dialytic treatment, in consequence influencing preservation of proper peripheral nerve function.

[Influence of microinflammation and oxidative stress on atherosclerosis progression and calcifications in cardiovascular system of hemodialyzed patients during two years follow-up]. / Wplyw mikrozapalenia i stresu oksydacyjnego na progresje miazdzycy i zwapnien w ukladzie krazenia u chorych hemodializowanych w okresie dwuletniej obserwacji.

Atherosclerosis and calcifications in the cardio-vascular system are the most frequent causes of increased morbidity and mortality in patients with end-stage renal disease treated with hemodialyses. The aim of this study was to estimate the atherosclerosis progression and presence of calcifications in the circulatory system in patients treated with hemodialyses using, non-invasive imaging diagnostic techniques and to search for the relationships between these changes and microinflammation and oxidative stress during two years. The study was performed in 73 patients (36 female and 37 male), aged 25 to 75 years (mean -49.5), treated with hemodialyses, 3 times/week for 12 to 275 months (mean -73.8). In each patient before starting hemodialysis levels of: ox-LDL, Lp (a), procalcitonin, IL-1beta, IL-6, CRP, TGFbeta, TNFalpha, PDGF, AOPP and MPO were determined. Presence of artery calcifications was detected by Multi-Row Spiral Computed Tomography (MSCT) and expressed as coronary artery calcification score (CACS). Ultrasonography was used to evaluate CCA-IMT. During the study CACS increased significantly after 12 and 24 months (p < 0.00001) as compare with baseline. After 12 months, CACS increase significantly correlated with procalcitonin level (r = 0.30 p = 0.01) and after 24 months with CRP (r = 0.46; p = 0.0002) and IL-6 (r = 0.36; p = 0.005). Independent factor of coronary artery calcification progression after 24 months of observation was only CRP (beta = 0.569). CCA-IMT increased during the study and this increase was statistically significant (p < 0.00001). CCA-IMT increase correlated with CACS growth after 12 (r = 0.36; p = 0.003) and 24 months (r = 0.39; p = 0.002). After 12 months significant relationship was noted with procalcitonin (r = 0.29; p = 0.022). After 24 months CCA-IMT correlated with AOPP (r = -0.30; p = 0.017). The independent factor of CCA-IMT progression after 24 months of observation was only CACS (delta CACS beta = 0.49). From the performed study, we can conclude that exacerbation of atherosclerosis and calcification in the circulatory system of patients treated with maintenance hemodialyses depends on microinflammation and oxidative stress. Reasonable tools for diagnostic algorithm estimation of atherosclerosis advancement in this group of patients are non-invasive, visual diagnostic techniques such as MSCT and ultrasonography.

Selenium status indices, laboratory data, and selected biochemical parameters in end-stage renal disease patients.

We investigated the relations between selenium status (SeS) parameters, indexes of nutrition, erythropoiesis, and uremic toxemia, serum electrolytes, and other biochemical markers in end-stage renal disease (ESRD) patients, as no multivariate statistical analysis concerning all of these parameters was performed so far. SeS was evaluated by plasma Se concentration (plSe) and glutathione peroxidase (plGSHPx) activity in 69 uremic patients treated with hemodialysis (HD) and 40 healthy controls. The hierarchical multivariate partial least squares model (PLS2) was employed to establish data structure and correlations between parameters investigated. plSe and plGSHPx activity were significantly lower in patients when compared with controls (p=0.000). plSe was positively associated with indexes of erythropoiesis and nutritional status, as well as serum electrolytes and parameters of uremic toxemia. plGSHPx was inversely dependent on the pair of parameters: intact parathyroid hormone (iPTH) and aluminum plasma concentration (Al). We conclude that (1) ESRD strongly decreases selenium status and (2) the PLS2 approach revealed the existence of significant interactions among plSe, plGSHPx, and selected biochemical parameters or groups of such parameters; some of these associations need further studies to be clarified.

Factors involved in vascular calcification and atherosclerosis in maintenance haemodialysis patients.

BACKGROUND: Atherosclerosis and vascular calcifications are common causes of morbidity and mortality in maintenance haemodialysis patients. In addition to the well-known traditional risk factors, uraemia-specific factors appear to enhance dramatically the progression of the pathological processes involved. The aim of the present study was to evaluate the degree of atherosclerosis and vascular calcifications in chronic haemodialysis patients using non-invasive imaging methods, and to identify potentially involved factors. METHODS: The study included 73 patients (36 females, 37 males), aged 25-75 years, who were on haemodialysis treatment for 12-275 months (mean dialysis vintage 73.8 months). We assessed the following circulating parameters: calcium (Ca), phosphorus, 'intact' parathyroid hormone (iPTH), 25OH vitamin D, lipids, oxidized LDL (ox-LDL), Lp(a), homocysteine, leptin, IL-1-beta, IL-6, CRP, TGF-beta, TNF-alpha, (PDGF), advanced oxidation protein products (AOPP) and myeloperoxidase activity (MPO). Coronary artery calcification score (CACS) was assessed using multi-row spiral CT (MSCT). Intima-media thickness index of the common carotid artery (CCA-IMT) and presence of cervical artery atherosclerotic plaques were evaluated by ultrasonography. RESULTS: Coronary artery calcifications were observed in 79.5% of the patients, with CACS ranging from 0 to 4987. In univariate analysis, a positive correlation was observed between CACS and age, BMI, iPTH, CRP, IL-6 and CCA-IMT, whereas an inverse correlation existed with 25OH vitamin D, TGF-beta and PDGF. CCA-IMT ranged from 0.4 to 1.1 mm. It was positively correlated, in univariate analysis, with age, CACS, CRP and Il-6, and negatively with 25OH vitamin D, TGF-beta and PDGF. Only CACS remained as independent predictive factor of CCA-IMT in multivariate analysis. Atherosclerotic plaques were found in the carotid arteries of 53 patients (72%). The number of plaques was positively correlated with age, CACS, phosphorus, MPO, CRP and IL-6, and inversely with 25OH vitamin D in univariate analysis. In multivariate regression analysis, only age and CACS remained as independent variables. CONCLUSION: In addition to classic risk factors, the degree of atherosclerosis and vascular calcification in our dialysis patient population were associated with several factors that are frequently abnormal in advanced chronic renal failure, but except age, all of them were interdependent. Notably, as in the general population, CACS was an independent predictor of the degree of atherosclerosis in haemodialysis patients.

[Body mass index (BMI) or bioimpedance analysis (BIA) --which method enables a better assessment of fat mass in children?]. / Wskaznik masy ciala (BMI) czy analiza bioimpedancji elektrycznej (BIA)--która metoda pozwala lepiej ocenic zawartosc tkanki tluszczowej u dzieci?

A comparison of accuracy between electrical bioimpedance analysis (BIA) and body mass index (BMI) for fat mass evaluation in children was the aim of the study. One-hundred and ninety three healthy children (90 females, 103 males) were enrolled. The mean age of the studied population was 11.8 years (+/- 2.2), mean weight equalled to 42.6 (+/- 12.8) kg and mean height-151.1 (+/- 13.5) cm. BIA measurments were performed by multifrequency (1; 5; 50; 100 kHz) BIA 2000M analyzer using BIANOSTIC electrods. Calculations of free fat mass and fat mass were performed using Nutri 4 Data Input Software (Germany). The LMS method for percentile charts of FFM and FM acording to height has been applied and results for boys and girls were drawn separatelly. Percentile charts of FM and BMI were compared. Different shape of curves of FM content and BMI for boys during puberty was noticed. BIA allows for precise fat mass content evaluation in children and its use should be disseminated.

The evaluation of the effectiveness of multiple dose intradermal hepatitis B re-vaccination in hemodialyzed patients not responding to standard method of immunization.

Hepatitis B is a serious epidemiological problem in uremic patients treated with renal replacement therapy. A high proportion of hemodialyzed patients do not respond to the standard method of intramuscular (i.m.) hepatitis B vaccination. Low-dose intradermal (i.d.) inoculations and supplementary i.m. injections have been reported to improve the responsiveness in formerly non responding uremic patients. We applied a inoculation schedule of 10 microg Engerix B i.d. in 49 pts and i.m. (control group) in 13 pts once a week during 12 consecutive weeks in order to compare the effectiveness of the various ways of immunization in maintenance dialyzed patients not responding to standard vaccination. Serum anti-HBs antibody level, as well as biochemical and immunological parameters were examined. Already one month after initiation of the cycle, 57.1% of patients in the i.d. group responded by achieving the minimum protective anti-HBs antibody level (>10 IU/I.); while 14.3% reached full adequate anti-HBs antibody level (>100 IU/I.). After the full therapy period, anti-HBs antibody level >100 IU/I. was achieved in 42.9% of the patients, while a total of 81.7% of patients reached the anti-HBs antibody level >10 IU/I. In 18.4% of patients no response was observed. Surprisingly similar results were achieved in the i.m. group. Twelve months after termination of the inoculation cycle we noted decrease of anti-HBs antibody level; the values >100 IU/ I. was observed only in 18.4% of the study group, while 87.8% reached a titre >10 IU/I. We found a relationship between the effectiveness of immunization and RBC count, total serum protein and albumin levels and GGTP activity. Mitogen stimulation indexes in both groups were 4-5 times lower in comparison to reference values in the general population. In the study group that did not respond to vaccination, mitogen stimulation indexes were 2 times lower as compared to the group characterized as having a good response. In conclusion, the route of injection seems to be less important than the frequency and number of doses of the vaccine. Anemia and malnutrition may be responsible for the worse response to vaccination against hepatitis B virus.

The influence of sodium profiling on blood volume and intradialytic hypotension in patients on maintenance hemodialysis.

An accurate evaluation of water content in the body of hemodialyzed patients seems to be an important problem in chronic dialysotherapy. Acute intradialytic hypotension observed in 20-33% of hemodialysis patients is a very common complication of this kind of renal replacement therapy. The study was performed in 40 uremic patients, treated with hemodialysis at the Nephrology Clinic of the University Hospital in Cracow. In every patient, 3 model dialysis sessions were carried out. Total fluid removal was the same during every hemodialysis. The first model hemodialysis (HD1) was performed with constant dialysate sodium concentration (140 mmol/L), the second (HD2) with linear and the third (HD3) with expotential decrease of dialysate sodium concentration (from 144 to 136 mmol/L). Every hemodialysis was also monitored continuously with Crit-Line 2 R system (In-Line Diagnostics, Riverdale, UT). Before and after the first model hemodialysis (HD1), ultrasound examination of abdominal cavity was performed. The measurement of inferior vena cava diameter (mm), circumference (mm), area (mm2), at hepatic veins orifice-level, on expiration was performed. The fluid removal during the first model hemodialysis resulted in significant reduction of the vena cava inferior diameter, circumference and area, measured with ultrasound on expiration. The statistically significant lower fall of blood volume after the first and second hour of the second model hemodialysis session (HD2) was observed when compared to the first hemodialysis (HD1) - p<0.05 was observed. The statistically significant lower frequency of hypotension during the second hemo-dialysis session (HD2) as compared to HD1 (chi2=5.25 p<0.05). Differences among HD1 and HD3 and HD2 and HD3 did not reach statistical significance. The monitoring of hemodialysis with the Crit-Line instrument permits for optimalization of dry weight of dialyzed patients and allows reaching higher ultrafiltration rates during dialysis without hypotensive episodes. The changes in the blood volume, approximately 5% per one hour of dialysis session are an optimal value for these patients.

[Preliminary assessment of heart function in chronically dialysed children]. / Wstepna ocena funkcji serca u dzieci przewlekle dializowanych.

UNLABELLED: Renal replacement therapy has become a recognized treatment modality of children with chronic renal failure (CRF). Despite of unquestionable progress in heamodialysis treatment quite high morbidity and mortality still remain a serious problem among pediatric patients. The most common cause of death in haemodialyzed and transplanted patients are cardiovascular complications. The main aim of the study was an echocardiographic (ECHO) assessment of selected cardiac parameters in heamodialyzed children. METHODOLOGY: 16 chronically dialyzed (6 HD, 10 PD) children participated in the study (10 M, 6 F), aged 5-18,5 yrs (x=12.2 +/- 3.8 yrs). Echocardiography examinations were carried out with HP 5500 device and S4 ultrasound probe of variable frequency. Diastolic and systolic LV dimension, ejection fraction (EF) and LV mass index (LVMI) were evaluated. By means of pulsating Doppler method mitral flow peak E and A velocity and isovolumetric relaxation time (IRT) were assessed. RESULTS: On the basis of ECHO examinations 3 groups were singled out: A (n=3) of normal heart function, B (n=3) of impaired systolic and diastolic heart function and C (n=10) of normal systolic and impaired diastolic heart function. In group of children with severe cardiac lesion (B group) a higher LV mass (A vs B vs C: 74.7 vs 119.9 vs 73.5 g/m2) and statistically significant lower ejection fraction (68.1 vs. 33.7 vs. 65.9%) were ascertained. These children were anuric (996 vs. 0 vs. 1112 mild), their systolic (102.1 vs. 118.4 vs. 117,9) and diastolic (64,4 vs. 84.8 vs. 77.9) blood pressure were significantly higher, so was the number or hipotensive medications (0.33 vs. 1.72 vs. 1,44). CONCLUSIONS: The great majority of chronically dialyzed children demonstrates an impairment of cardiac function mainly of diastolic parameters. Anuria and hypertension stand for a significant risk factor of cardiac lesion.