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

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hemodialysis sessions
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease (ESRD) focused on measuring hemodialysis, protein energy wasting, medium cut-off dialyzer, lean mass, bioimpedance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU de Poitiers
  • AURA Poitou-Charentes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MCO-HD group

HF-HD group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2022
Last Updated
July 20, 2023
Sponsor
Poitiers University Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05309109
Brief Title
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study
Acronym
EMCOPEW
Official Title
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study. Medium Cut-Off Hemodialysis and Protein Energy Wasting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 26, 2024 (Anticipated)
Study Completion Date
June 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
hemodialysis, protein energy wasting, medium cut-off dialyzer, lean mass, bioimpedance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCO-HD group
Arm Type
Experimental
Arm Description
Hemodialysis sessions using the Theranova 500™ (Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg)
Arm Title
HF-HD group
Arm Type
Experimental
Arm Description
Hemodialysis sessions using the Elisio 21H™ (Nipro Europe, Zaventen Belgium; surface area 2.1 m², ultrafiltration coefficient: 82 ml/h/mmHg)
Intervention Type
Other
Intervention Name(s)
Hemodialysis sessions
Intervention Description
Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.
Primary Outcome Measure Information:
Title
The change from baseline to the end of the study in lean tissue mass measured using Bioimpedance analysis through the study.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
AURA Poitou-Charentes
City
Saint-Benoît
ZIP/Postal Code
86281
Country
France

12. IPD Sharing Statement

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

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