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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05419271

Acronym

CIMHBaDD

Enrollment

Registered

2022-06-15

Start date

2022-05-09

Completion date

2022-09-30

Last updated

2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Daily Home Hemodialysis

Keywords

daily dialysis, home hemodialysis, Middle-molecular weight toxins, Beta2-microglobulin, Push-Pull

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.

Interventions

PROCEDUREhome hemodialysis session with 9L internal convection

home hemodialysis session with 9L internal convection

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Middle molecular weight toxins clearance	during hemodialysis procedure	Beta2-microglobulin levels

Countries

France

Contacts

Primary ContactMaxence FICHEUX

ficheux-m@chu-caen.fr0231063106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026