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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04892745
Other study ID # APHP210098
Secondary ID 2020-A03337-32
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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