Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

Study Overview
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Brief Summary
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Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Detailed Description
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Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state. Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called push pulls and uses internal convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis. Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection. The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.

Official Title
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Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

Conditions
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Daily Home Hemodialysis

Intervention / Treatment
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* Procedure: home hemodialysis session with 9L internal convection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: home hemodialysis since at least 2 weeks hemodialysis since at least 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis, intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental convection<br>session of dialysis with 9L internal convection | Procedure: home hemodialysis session with 9L internal convection<br>* home hemodialysis session with 9L internal convection<br>|
| No Intervention: free internal convection<br>session of dialysis with free internal convection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle molecular weight toxins clearance | Beta2-microglobulin levels | during hemodialysis procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home hemodialysis, Middle-molecular weight toxins, Beta2-microglobulin, Push-Pull, daily dialysis