Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

Recruiting

• Conditions: Hemodialysis

• Registration Number: NCT04892745
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

Detailed Description

The study will be realized in dialysis facility of Ambroise Paré hospital, APHP. The duration of enrollment of subjects will be 3 months, each enrolled patient will has 2 or 3 week's follow-up.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-19
• Study Start: 2021-09-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient ⩾ 18 years;
• Patient undergoing chronic dialysis in hemodialysis facility of Ambroise Paré hospital;
• Patient has been informed and given no-opposition for participating to the study.

Exclusion Criteria

• Patient with a pacemaker or an implantable cardioverter defibrillator;
• Patient under guardianship or curatorship;
• Foreign patient under french AME scheme.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electrical parameters of subcutaneous impedancemetry	at the end of study, up to 4 months	Electrical parameter extracellular resistance (Re) will be assessed.

Secondary Outcome Measures

Name	Time	Method
Whole body impedancemetry assessement	at the end of study, up to 4 months	Whole body impedancemetry will be assessed by Re.
Cutaneo-muscular impedancemetry assessement	at the end of study, up to 4 months	Cutaneo-muscular impedancemetry will be assessed by extracellular resistance (Re).
Incidence of volemic or neuromuscular events	at the end of study, up to 4 months	Incidence of volemic or neuromuscular events during the session, such as: * peridialytic hypotension,; * crampses.

Trial Locations

Locations (1)

Service de Néphrologie, Hôpital Ambroise Paré, APHP; 🇫🇷 Boulogne-Billancourt, France