Measurements of total-body electrical impedance in the frequency range between 200 Hz and 300 kHz were performed on 37 diabetic patients undergoing chronic haemodialysis. Special attention was paid to the instrument design, where a self-balancing differential current source was used, reducing considerably the common-mode voltage at the amplifier input. The patient-instrument interface includes screened leads, separately driven by unity-gain buffers. The measurement error was < 1% for the impedance within the range of 20 to 1000 omega and < 0.3 degree (mean) for the phase angle. Impedance/phase and ultrafiltration measurements were carried out throughout the entire procedure. Total and extracellular water were computed and compared with extracted fluid volumes. The trends of change of the extracellular and intracellular fluid volumes during and immediately after dialysis corresponded to the respective clinical condition of the patients and enabled us to divide them into four groups. This approach is a step toward continuous monitoring and adaptive treatment, tailored to the individual patient needs.
This study evaluated the effect of age and renal impairment on pharmacokinetics of trimetazidine (TMZ) in healthy elderly and renally impaired subjects and assess safety and tolerability. In this open‐label, multi‐dose study, 73 subjects were divided into six treatment groups: (1) 55–65 years; (2) 66–75 years; (3) >75 years (dosing for groups 1–3 [healthy]: B.D. for 4 days), (4) mild renally impaired (dosed B.D. for 8 days); (5) moderate renally impaired (dosed O.D. for 8 days); and (6) severe renally impaired‐no dialysis (dosed once every 48 h for 8 days). Blood and urine samples were collected and analyzed. The geometric least squares mean ratios for; Group 2 and 1 of AUC(0−τ)ss was 112.2 (90% CI; 92.0–136.8) and Cmax,ss was 109.9 (89.6–134.8), Group 3 and 1 of AUC(0−τ),ss was 140.5 (115.9–170.3) and Cmax,ss was 137.8 (112.9–168.2), Group 4 and 1 of AUC(0−τ),ss was 114.2 (90.3–144.4) and Cmax,ss was 120.8 (92.5–157.8), Group 5 and 1 of; AUC(0−τ),ss was 213.0 (153.1–296.3) and Cmax,ss was 123.3 (92.2–164.7) and Group 6 and 1 of AUC(0−τ),ss was 247.4 (197.8–309.6) and Cmax,ss was 95.6 (73.0–125.1). Significant increase in systemic exposure of TMZ was observed in subjects; over 75 year's age and renally impaired compared to healthy subjects. TMZ was safe and well‐tolerated.
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