MedTrace Logo

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

NCT05309109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-04-11

No results posted yet for this study

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

Conditions

  • End Stage Renal Disease (ESRD)

Interventions

OTHER

Hemodialysis sessions

Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2025-03-27
Completion
2025-03-27

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309109 on ClinicalTrials.gov