Two 750-mg infusions of FCM are a safe and effective alternative to multiple lower dose iron sucrose infusions in NDD-CKD patients with iron-deficiency anemia.
Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V urea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data.Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V urea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home.
Nine patients receiving maintenance high-efficiency hemodialysis were studied before and after a 12-week conditioning program to determine the efficacy of exercise immediately following hemodialysis. Each patient performed a combination of bicycle ergometry on the Schwinn Air-Dyne ergometer (SAE) and treadmill walking three times a week for a total exercise time of 15–35 min per session. A low-level Bruce treadmill test and an exercise test on the SAE were administered before and after training. Hematological, serum electrolyte, and serum lipid profiles were also determined before and after training. Following training, there were improvements in exercise capacities for both treadmill walking and ergometry on the SAE. Although a significant increase in serum apolipo-protein Al was seen following exercise, no significant changes were observed for total cholesterol, low-density -lipoprotein cholesterol, high-density-lipoprotein cholesterol or apolipoprotein B. Additionally, no significant changes were seen in hematological parameters and serum electrolyte profiles following the exercise program. The 9 patients demonstrated an average compliance record of 74%. This study demonstrated that patients on high-efficiency hemodialysis can safely engage in an exercise program immediately following dialysis at intensities and frequencies that can improve their physical work capacities.
Aluminum toxicity in dialysis patients is associated with decreased bone turnover and a relative parathyroid hormone (PTH) deficiency. Desferrioxamine (DFO), a chelating agent, has been reported to improve bone histology in aluminum associated, low turnover bone disease in dialysis patients not subjected to parathyroidectomy. Information on the effect of DFO therapy on parathyroid gland function is lacking. In the present study, in addition to changes in bone histology, parathyroid gland function was evaluated in 18 hemodialysis patients with aluminum associated, low turnover bone disease (osteomalacia and aplastic bone disease) before and after one year of DFO treatment (1 to 6 g/week). Parathyroid gland function was assessed by using a calcium free and high calcium (3.5 to 4 mEq/liter) hemodialysis bath.(ABSTRACT TRUNCATED AT 250 WORDS)
Diabetic patients on maintenance dialysis often are characterized by a relative parathyroid hormone (PTH) deficiency and a form of renal osteodystrophy with low bone turnover known as adynamic bone. The goal of the present study was to determine whether a reduction in the dialysate calcium concentration would increase the predialysis (basal) PTH and maximal PTH level. Thirty-three diabetic maintenance hemodialysis patients with basal PTH values less than 300 pg/ml were randomized to be dialyzed with either a regular (3.0 mEq/liter or 3.5 mEq/liter, group I) or low (2.25 mEq/liter or 2.5 mEq/liter, group II) calcium dialysate for 1 year. At baseline and after 6 months and 12 months of study, low (1 mEq/liter) and high (4 mEq/liter) calcium dialysis studies were performed to determine parathyroid function. At baseline, basal (I, 126 ؎ 20 vs. II, 108 ؎ 19 pg/ml) and maximal (I, 269 pg/ml ؎ 40 pg/ml vs. II, 342 pg/ml ؎ 65 pg/ml) PTH levels were not different. By 6 months, basal (I, 98 ؎ 18 vs. II, 200 ؎ 34 pg/ml, p ؍ 0.02) and maximal (I, 276 pg/ml ؎ 37 pg/ml vs. II, 529 pg/ml ؎ 115 pg/ml; p ؍ 0.05) PTH levels were greater in group II. Repeated measures analysis of variance (ANOVA) of the 20 patients who completed the entire 12-month study showed that only in group II patients were basal PTH (p ؍ 0.01), maximal PTH ( p ؍ 0.01), and the basal/maximal PTH ratio ( p ؍ 0.03) different; by post hoc test, each was greater ( p < 0.05) at 6 months and 12 months than at baseline. When study values at 0, 6, and 12 months in all patients were combined, an inverse correlation was present between basal calcium and both the basal/maximal PTH ratio (r ؍ ؊0.59; p < 0.001) and the basal PTH (r ؍ ؊0.60; p < 0.001). In conclusion, in diabetic hemodialysis patients with a relative PTH deficiency (1) the use of a low calcium dialysate increases basal and maximal PTH levels, (2) the increased secretory capacity (maximal PTH) during treatment with a low calcium dialysate suggests the possibility of enhanced parathyroid gland growth, and (3) the inverse correlation between basal calcium and both the basal/maximal PTH ratio and the basal PTH suggests that the steady-state PTH level is largely determined by the prevailing serum calcium concentration.
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