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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05309109

Collaborator

Baxter Healthcare Corporation (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease (ESRD)	Other: Hemodialysis sessions	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MCO-HD group Hemodialysis sessions using the Theranova 500™ (Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg)	Other: Hemodialysis sessions Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.
Experimental: HF-HD group Hemodialysis sessions using the Elisio 21H™ (Nipro Europe, Zaventen Belgium; surface area 2.1 m², ultrafiltration coefficient: 82 ml/h/mmHg)	Other: Hemodialysis sessions Patients will receive thrice weekly 4 hours hemodialysis sessions during 12 months.

Arm

Intervention/Treatment

Experimental: MCO-HD group

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

Other: Hemodialysis sessions

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

Experimental: HF-HD group

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

Other: Hemodialysis sessions

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

Outcome Measures

Primary Outcome Measures

The change from baseline to the end of the study in lean tissue mass measured using Bioimpedance analysis through the study. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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