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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05419271

Collaborator

(none)

Enrollment

Location

Arms

3.8

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Daily Home Hemodialysis	Procedure: home hemodialysis session with 9L internal convection	N/A

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

Anticipated Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental convection session of dialysis with 9L internal convection	Procedure: home hemodialysis session with 9L internal convection home hemodialysis session with 9L internal convection
No Intervention: free internal convection session of dialysis with free internal convection

Arm

Intervention/Treatment

Experimental: experimental convection

session of dialysis with 9L internal convection

Procedure: home hemodialysis session with 9L internal convection

home hemodialysis session with 9L internal convection

No Intervention: free internal convection

session of dialysis with free internal convection

Outcome Measures

Primary Outcome Measures

Middle molecular weight toxins clearance [during hemodialysis procedure]
Beta2-microglobulin levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Caen Normandie	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT05419271

Other Study ID Numbers:

22-0017

First Posted:

Jun 15, 2022

Last Update Posted:

Jun 15, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Caen

daily dialysis

home hemodialysis

Middle-molecular weight toxins

Beta2-microglobulin

Push-Pull

Study Results

No Results Posted as of Jun 15, 2022