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Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study — EMCOPEW  

End Stage Renal Disease (ESRD) Clinical Trial

Official title:
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting

Clinical Trial Summary

In patients on maintenance hemodialysis (HD), protein energy wasting (PEW) defined as loss of muscle mass and fuel reserves of the body is frequent and associated with severe morbidity and mortality. Several factors, including inflammation, oxidative stress, metabolic disorders, loss of nutrients, diabetes, retention of middle molecule uremic toxins and dialysis procedure contribute to PEW. It has been previously reported that intensive HD treatments such as short daily and nocturnal HD may improve nutritional parameters. Moreover, post-dilution Online hemodiafiltration (OL-HDF) may also improve PEW by preserving lean body mass evaluated by bioimpedance analysis (BIA) probably through decreased inflammation, stimulation of appetite and better removal of uremic toxins. The recently developed medium cut-off dialyzer (MCO) in HD has demonstrated efficient depuration of middle uremic toxins as compared to high flux HD (HF-HD), similar to that of OL-HDF. Both MCO-HD and OL-HDF may exert beneficial effects on PEW, since they increase removal of higher weight middle molecules, which mostly encompass proteins related to inflammation and PEW in the uremic milieu

Clinical Trial Description

In a previous randomized study, we found, that after 3 months, MCO-HD was associated with higher middle molecules removal and significant decrease in beta2-microglobulin, oxidized low-density lipoprotein, kappa and lambda free light chain pre-dialysis levels, without change in other inflammatory and oxidative stress biomarkers. In addition, compared to HF-HD, a modulation of inflammation has been demonstrated with MCO-HD in another randomized trial. After 3 months, MCO-HD was shown to downregulate the expression of the pro-inflammatory IL-6 and tumor necrosis factor (TNF) mRNA in peripheral leucocytes. Moreover, higher removal and decrease in TNF alpha level with concurrent reduced resistance to erythropoiesis stimulating agents (ESA) has been also reported with MCO-HD. However, the long-term effects of MCO-HD on inflammatory, uremic toxins and malnutrition biomarkers remain to be established. To test the hypothesis that MCO-HD may positively affect body composition and nutritional status in HD patients we performed a 12-month single center retrospective pilot study. Compared to HF-HD, MCO-HD resulted in an improved variation rate of serum pre-dialysis creatinine level, lean tissue, skeletal muscle mass and index assessed by BIA, which are presumably good surrogate markers of PEW. The aim of the present prospective, controlled randomized study is to evaluate the effect of MCO-HD on PEW, compared to standard HF-HD in chronic hemodialysis patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05309109
Study type Interventional
Source Poitiers University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date September 26, 2022
Completion date June 26, 2024
View Details
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