Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

Hemodialysis Clinical Trial

— H-ICMUS  

Official title:

Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892745
• Other study ID #: APHP210098
• Secondary ID: 2020-A03337-32
• Status: Recruiting
• Start date: September 29, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie ESSIG, MD, PhD
• Phone: + 33 1 49 09 56 48
• Email: marie.essig[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis

Locations

Country	Name	City	State
France	Service de Néphrologie, Hôpital Ambroise Paré, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical parameters of subcutaneous impedancemetry	Electrical parameter extracellular resistance (Re) will be assessed.	at the end of study, up to 4 months
Secondary	Cutaneo-muscular impedancemetry assessement	Cutaneo-muscular impedancemetry will be assessed by extracellular resistance (Re).	at the end of study, up to 4 months
Secondary	Whole body impedancemetry assessement	Whole body impedancemetry will be assessed by Re.	at the end of study, up to 4 months
Secondary	Incidence of volemic or neuromuscular events	Incidence of volemic or neuromuscular events during the session, such as: peridialytic hypotension,; crampses.	at the end of study, up to 4 months