Hemodialysis patients treated with Optiflux® high flux single-use dialyzers experienced a mean increase in serum albumin levels, according to results from a recent clinical trial and separate retrospective analysis conducted by Fresenius Medical Care North America.
| WALTHAM, Mass., March 26, 2020 /PRNewswire/ -- Hemodialysis patients treated with Optiflux® high flux single-use dialyzers experienced a mean increase in serum albumin levels, according to results from a recent clinical trial and separate retrospective analysis conducted by Fresenius Medical Care North America. The results are included in two abstracts presented virtually this week as part of the National Kidney Foundation (NKF) 2020 Spring Clinical Meetings.
The preservation of albumin is important because a low level of albumin, known as hypoalbuminemia, has been previously associated with increased morbidity and mortality in patients on maintenance hemodialysis (HD).1,2 Optiflux high-flux dialyzers are designed to enhance small and middle molecule clearance without increasing albumin loss.3 The first abstract, Clinical Performance Of The Optiflux® F160NR Dialyzer, examines the results from a recent clinical trial that included a period of four weeks during which patients were using the F160NR Optiflux dialyzer. Within a single HD session in 23 patients, mean (SD) serum albumin increased from a pre-HD value of 3.97g/dL (0.31) to 4.29 g/dL (0.4) post-HD over the course of an HD session. In the second abstract, Evaluation of Biomarkers in Chronic Hemodialysis (HD) Patients Dialyzed with Optiflux High-flux Dialyzers, 976 in-center incident HD patients treated exclusively with Optiflux high-flux dialyzers for 6 months were analyzed as part of a retrospective analysis and showed a moderate, but statistically significant increase in serum albumin and a significant increase in hemoglobin, while maintaining dialysis adequacy. Within a sub-group of 156 patients with hypoalbuminemia at the start of the study, 87 percent of these patients had increases in serum albumin by the sixth month regardless of the Optiflux model (48/59 or 81.4 percent in F160NR, 82/92 or 89.1 percent in F180NR, and 5/5 or 100 percent in F200NR and F250NR). Overall, the mean increase in serum albumin was 0.31 g/dL in the hypoalbuminemia subgroup. “The results described in these abstracts are further indication of the benefit Optiflux dialyzers provide with regards to preserving serum albumin levels in patients on maintenance hemodialysis,” said Dr. Michael Anger, Chief Medical Officer for Renal Therapies Group at Fresenius Medical Care North America. “This is important, as many studies have demonstrated the potential dangers of low serum albumin levels, especially when patients have hypoalbuminemia at the start of hemodialysis.” For more information about Optiflux high flux single-use dialyzers, please visit here. 1Owen et al, NEJM, 1993. The urea reduction ratio and serum albumin concentration as predictors of mortality in patients undergoing hemodialysis. INDICATIONS FOR USE: Caution: Federal (US) law restricts these devices to sale by or on order of a physician. Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling at fmcna.com. In rare cases, thrombocytopenia or hypersensitivity reactions including anaphylactic or anaphylactoid reactions to the dialyzer, or other elements in the extracorporeal circuit may occur during hemodialysis. About Fresenius Medical Care North America Media Contact: Fresenius Medical Care North America
SOURCE Fresenius Medical Care Holdings, Inc. |
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