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Clinical Trials/NCT05419271
NCT05419271UnknownNot Applicable

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

University Hospital, Caen1 site in 1 country16 target enrollmentStarted: May 9, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
16
Locations
1
Primary Endpoint
Middle molecular weight toxins clearance

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •home hemodialysis since at least 2 weeks
  • •hemodialysis since at least 3 months

Exclusion Criteria

  • Not provided

Arms & Interventions

free internal convection

No Intervention

session of dialysis with free internal convection

experimental convection

Experimental

session of dialysis with 9L internal convection

Intervention: home hemodialysis session with 9L internal convection (Procedure)

Outcomes

Primary Outcomes

Middle molecular weight toxins clearance

Time Frame: during hemodialysis procedure

Beta2-microglobulin levels

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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