Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

NCT04892745 | Completed

• 2 other identifiers: APHP2100982020-A03337-32
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Keywords

hemodialysis; electrical impedance; subcutaneous impedancemetry; cutaneo-muscular impedancemetry

Outcome Measures

Primary Outcomes (1)

• Electrical parameters of subcutaneous impedancemetry

  Electrical parameter extracellular resistance (Re) will be assessed.

  at the end of study, up to 4 months

Secondary Outcomes (3)

• Cutaneo-muscular impedancemetry assessement

  at the end of study, up to 4 months

• Whole body impedancemetry assessement

  at the end of study, up to 4 months

• Incidence of volemic or neuromuscular events

  at the end of study, up to 4 months

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Néphrologie, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

Location

Study Officials

• Marie ESSIG, MD, PhD

  Service de Néphrologie, Hôpital Ambroise Paré, APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: May 19, 2021
• Study Start: September 29, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)