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

NCT05309109 | Completed

• 1 other identifier: EMCOPEW
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

hemodialysis; protein energy wasting; medium cut-off dialyzer; lean mass; bioimpedance

Outcome Measures

Primary Outcomes (1)

• The change from baseline to the end of the study in lean tissue mass measured using Bioimpedance analysis through the study.

  12 months

Study Arms (2)

MCO-HD group

EXPERIMENTAL

Hemodialysis sessions using the Theranova 500™ (Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg)

Other: Hemodialysis sessions

HF-HD group

EXPERIMENTAL

Hemodialysis sessions using the Elisio 21H™ (Nipro Europe, Zaventen Belgium; surface area 2.1 m², ultrafiltration coefficient: 82 ml/h/mmHg)

Other: Hemodialysis sessions

Interventions

Hemodialysis sessions OTHER

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

HF-HD group; MCO-HD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to give signed informed consent
• Age ≥ 18 years
• Patients established on HF-HD trice weekly four hour-sessions for at least 3 months.
• Patients able to walk
• Body mass index ≥ 20 and \< 40 Kg/m2

You may not qualify if:

• Any uncontrolled medical condition, psychiatric disorder or biological abnormality that might interfere with subject's participation or ability to sign an informed consent.
• Implanted pace maker or cardioverter defibrillator
• Pregnant or breast-feeding women
• Active malignant disease, chronic inflammatory disease or other critical illnesses that may interfere with inflammatory parameters. Baseline C-reactive protein \> 35 mg/l.
• Amputated limbs
• Prescription of oral or intra venous nutrition supplements
• Significant residual kidney function as defined by an urine output \> 500 mL

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

CHU de Poitiers

Poitiers, 86000, France

Location

AURA Poitou-Charentes

Saint-Benoît, 86281, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: September 26, 2022
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)