Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance (H-ICMUS)

September 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Service de Néphrologie, Hôpital Ambroise Paré, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients suffering chronic renal failure and undergoing chronic hemodialysis in Ambroise Paré hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical parameters of subcutaneous impedancemetry
Time Frame: at the end of study, up to 4 months
Electrical parameter extracellular resistance (Re) will be assessed.
at the end of study, up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneo-muscular impedancemetry assessement
Time Frame: at the end of study, up to 4 months
Cutaneo-muscular impedancemetry will be assessed by extracellular resistance (Re).
at the end of study, up to 4 months
Whole body impedancemetry assessement
Time Frame: at the end of study, up to 4 months
Whole body impedancemetry will be assessed by Re.
at the end of study, up to 4 months
Incidence of volemic or neuromuscular events
Time Frame: at the end of study, up to 4 months

Incidence of volemic or neuromuscular events during the session, such as:

  • peridialytic hypotension,
  • crampses.
at the end of study, up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Marie ESSIG, MD, PhD, Service de Néphrologie, Hôpital Ambroise Paré, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Actual)

May 25, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP210098
  • 2020-A03337-32 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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