Impact of Hemodialysis on Cutaneo-muscular Electrical Imp... | NCT04892745

Studies
Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

NCT04892745

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 2, 2025Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Hemodialysis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A03337-32	Registry Identifier	IDRCB

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2021Actual

Primary Completion Date

May 25, 2022Actual

Completion Date

May 25, 2022Actual

First Submitted Date

Apr 16, 2021

First Submission Date that Met QC Criteria

May 14, 2021

First Posted Date

May 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie ESSIG, MD, PhD	Service de Néphrologie, Hôpital Ambroise Paré, APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Néphrologie, Hôpital Ambroise Paré, APHP		Boulogne-Billancourt		92100	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided