Status:
COMPLETED
Effect of Medium Cut-Off Hemodialysis on Protein Energy Wasting: The EMCOPEW Study
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
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 lipoprot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05309109
Start Date
September 26 2022
End Date
March 27 2025
Last Update
April 11 2025
Active Locations (2)
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1
CHU de Poitiers
Poitiers, France, 86000
2
AURA Poitou-Charentes
Saint-Benoît, France, 86281