Subcutaneous CERA for the treatment of chronic renal anemia in predialysis patients

Background: We investigated the efficacy, safety and tolerability of once-monthly administration of C.E.R.A. in erythropoiesis stimulating agents (ESAs) naive predialysis patients with CKD for anemia treatmentStudy Design: Single arm, open label study.Methods: A total of 75 patients (mean (SD) age was 52.8 (16.4) years, 76.0% were female) were included in this study conducted between 12 August 2008 and 30 October 2009 in 9 centers across Turkey. The mean change in Hb concentration (g/dL) between baseline (week 0) and the efficacy evaluation period (EEP) was the primary efficacy parameter evaluated in three consecutive periods including a dose titration period (DTP; with initial 1.2 mu g/kg dose of C.E.R.A., subcutaneously, 28 weeks), EEP (8 weeks) and a long-term safety period (16 weeks).Results: Our analysis revealed an improvement in Hb levels from baseline value of 9.4 (0.4) g/dL to time adjusted average level of 11.4 (0.7) g/dL in EEP in the per protocol (PP) population and from 9.3 (0.5) g/dL to 11.1 (1.0) g/dL in intent-to-treat (ITT) population. Mean (SD) change in Hb levels from baseline to EEP was 2.0 (0.7) g/dl in the PP population (primary endpoint) and 1.7 (1.1) g/dL in the ITT population. The percentage of patients whose Hb concentrations remained within the target range of 10.0-12.0 g/dL throughout the EEP was 43.9% (95% CI: 28.5-60.3%) in the PP population and 38.7% (95% CI: 27.6% to 50.6%) in the ITP population. A total of 206 adverse events (AE) were reported in 77.0% of patients with hypertension (20%) as the most frequent AE.Conclusion: Once-monthly subcutaneous C.E.R.A. administration is effective and safe in the treatment of anemia in pre-dialysis patients with CKD, who are not currently treated with ESAs

Thermal stress analysis and residual stresses in a thermoplastic composite beam

In this study, an elastic-plastic thermal stress analysis is carried out on a steel fibre reinforced thermoplastic matrix composite beam. Temperature is chosen to vary linearly, that is zero and T-o at the upper and lower surfaces, respectively. The beam is fixed by two rigid planes at the ends. The solution is performed at 0degrees, 45degrees, 60degrees, 75degrees and 90degrees orientation angles. Plastic yielding is not obtained for 30degrees orientation angle. The plastic region is expanded at the lower side of the beam. It is found that the intensity of the residual stress component of sigma(x) and the equivalent plastic strain are maximum at the lower surface of the beam. The residual stress is found to be greatest for 0degrees orientation angle. The intensity of the equivalent plastic strain is the greatest for 45degrees orientation angle. In addition, for the same plastic distribution, the intensity of the transverse displacement is the largest for that orientation angle

Effect of Local Polyhexanide Application in Preventing Exit-Site Infection and Peritonitis: A Randomized Controlled Trial

Topical antibiotic and antiseptic agents have been documented to reduce exit-site infection (ESI) and peritonitis in PD. The aim of this randomized controlled study was to evaluate the efficacy of polyhexanide in the prevention of ESI and peritonitis. Patients were excluded if they had active infection, > 18 years of age, ESI and peritonitis within the previous 4 weeks, received PD for less than 3-months and history of allergy to either drug. All patients were followed up until catheter removal, death, switch to dialysis, transplantation or the end of the study. ESI, tunnel infection, peritonitis, catheter removal and microorganism cause of catheter-related infection were recorded prospectively during clinic follow-up. A total of 88 patients (41 povidone-iodine group; 47 polyhexanide group) were enrolled with a total follow-up duration of 480 and 555 patient-months for povidone-iodine and alternating group, respectively. There were no significant differences in the age, sex, BMI, time of PD, rate of DM, and S. aureus carriage state. A total of 8 ESI and 25 peritonitis episodes were detected during the study. ESI and peritonitis rates tended to be lower in polyhexanide group compared with the povidone-iodine group (0.06 episodes/patient-year vs. 0.12 episodes/patient-year; 0.26 episodes/patient-year vs. 0.32 episodes/patient-year, respectively), but were not significant statistically. Moreover, catheter removal was similar in both groups (0.04 / patient-year vs. 0.05 / patient-year). Polyhexanide is efficient and safe for the prevention of ESI and peritonitis and it may be used as an alternative procedure for the care of healthy exit sites. © 2019 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therap

Mediterranean Fever

BackgroundCirculating levels of Pentraxin-3 (PTX3) have been shown to increase in several inflammatory conditions. However, there is no information about the levels of PTX3 in patients with familial Mediterranean fever (FMF). This study was designed to evaluate the serum PTX3 levels in patients with FMF during attack and free-attack periods.MethodsTwenty FMF patients in attack and free-attack period, and 20 age-, sex-, and body mass index-matched healthy controls were included in the study. Blood samples were obtained within the first 24 h of the attack period and between attacks, and levels of white blood cell, erythrocyte sedimentation rate, Fibrinogen, high sensitive CRP, and PTX3 were determined.ResultsPTX3 levels during the attack period were not significantly different from those in free-attack patients (4.9 4.6 ng/ml vs. 2.8 +/- 1.4 ng/ml, P > 0.05). However, both attack and free-attack patients had significantly higher PTX3 levels than healthy controls (4.9 +/- 4.6 ng/ml vs. 1.8 +/- 0.8 ng/ml, P < 0.001; 2.8 +/- 1.4 ng/ml vs. 1.8 +/- 0.8 ng/ml, P < 0.025, respectively).ConclusionsPTX3 levels were not markedly affected from FMF attacks, but high level of PTX3 in free-attack period of FMF patients shows ongoing subclinical inflammation. However, further studies are needed to determine its usefulness as a marker in clinical practice

Influence of intraperitoneal volume on QT dispersion in patients with continuous ambulatory peritoneal dialysis: Acute cardiac impact of peritoneal dialysis

Aim: The leading cause of mortality in dialysis patients is cardiovascular complications, including ventricular arrhythmias and sudden cardiac death. QT dispersion (QTd), a simple noninvasive arrhythmogenic marker, is used to assess homogeneity of cardiac repolarization. It was also significantly prolonged in continuous ambulatory peritoneal dialysis (CAPD) patients. The acute cardiac effect of increased abdominal pressure due to infused dialysate during CAPD is not clear yet. In this study we aimed to evaluate corrected QTd (cQTd) and cardiac injury markers such as plasma pro-brain natriuretic peptide (proBNP) and troponin I (TnI) in CAPD patients before and after an infusion of peritoneal dialysate fluid. Methods: Thirty subjects (16 women, 14 men; mean age, 40.21 ± 12.34 years) enrolled in our study. QTd, cQTd, maximum QT (QTmax), maximum corrected QT (cQTmax), minimum QT (QTmin), and minimum corrected QT (cQTmin) intervals were measured from standard 12-lead electrocardiography. Results: We found that cQTmax, cQTmin, and cQTd were not changed from baseline measurement after infusion of dialysate in CAPD patients (460 ± 49 vs. 460 ± 38, p = 0.9; 410 ± 36 vs. 410 ± 41, p = 0.8; 470 ± 30 vs. 460 ± 25, p = 0.7, respectively). There were no statistically significant differences between before and after peritoneal dialysate according to the levels of proBNP and TnI (155.64 ± 76.41 vs. 208.30 ± 118.46, p = 0.2; 0.008 ± 0.007 vs. 0.01 ± 0.011; p = 0.4, respectively). Conclusion: In conclusion, we did not find any significant effect of peritoneal dialysate fluid infusion volume on QTd and cardiac injury markers in patients with chronic renal failure receiving CAPD therapy, which is thought to be a safer modality of dialysis. © 2011 Informa Healthcare USA, Inc

dialysate in peritoneal dialysis

Background/Aim: Oral essential amino acids (AAs) containing supplements (EAS) and AA containing dialysate (ACD) are frequently used in peritoneal dialysis (PD) patients with malnutrition. The present study was conducted to investigate two strategies and compare their effects on the malnutrition status of PD patients. Materials and Methods: A total of 31 EAS, 14 ACD patients were enrolled in this study. Serum albumin levels were lower than 3.5 g/dL in all subjects. EAS group patients took five pills containing AAs three times a day with meals. In the other, 2.000 cc of 1.1% ACD was given to patients daily during the study. Demographic and laboratory parameters were analyzed and compared at baseline and 6th month. Results: Significant increases in BMI, albumin, and protein in both groups. Mean albumin levels increased significantly by 0.54 g/dL in ACD group (p<0.005) and 0.49 g/dL in EAS group (p<0.001) following 6 months. Mean albumin and delta albumin levels did not differ between two groups. Conclusion: These strategies may play an important role in increasing albumin levels and improving the nutritional status of PD patients